Lead Optical Engineer

Responsible for providing leadership in the direction, planning, strategy and execution of the development of endoscopes for use with surgical system. This individual will work closely with external partners to develop the technical approach, detailed design and implementation path to bring a new laparoscope to market. This position will also oversee the testing and regulatory compliance for the project, ensuring that the development efforts meet the design control standards of a regulated marketplace.

Duties:

Work with external development partners to determine technical approach and detailed implementation plan.

Engage in design and test activities to supplement external efforts and ensure that market requirements are being achieved.

Create and develop product documentation, including systems, hardware and software specifications, design descriptions, verification and validation protocols, test reports, engineering studies and others as required.

Interface with engineering leaders engaged with other aspects of system to ensure that overall clinical and project requirements are met.

Coordinate project management activities within optical development.

Support FDA product approval submissions (510k, PMA) and CE Marking.

Communicate development status and strategy to the Executive Management Team.

Qualifications:

Bachelor’s degree in Optical Engineering or any other relevant degree

A minimum of 10 years of engineering experience developing optical systems within a medical device industry.

A solid working knowledge of regulatory requirements for optical system development, including knowledge of standards such as IEC 60601, ISO 13485, ISO 14971.

Experience with electromechanical systems integration strongly preferred.

Excellent project management skills and experience with product development from product conception through launch.

Sr. Optical Engineer

The Optical Engineer will develop and prototype optical systems for the Commercial Communications product line. In this responsibility they also will aid in the integration of the optical design into the system and the qualification. Responsibilities will include design and development of optical systems and subsystems. The potential candidate is an individual who is dedicated, articulate, energetic, and results oriented team player with positive attitude and excellent people skills.

KEY RESPONSIBILITIES:

Develop and prototype optical system for commercial communications utilizing various optical elements and sensors

Develop and implement optical test systems for commercial communications

Write detailed optical specifications and coordinate with optics vendors

Design test methodologies for system level validation and component test

Data collection and analysis of test links and from field trials

Understand and access technical trade-offs and recommend architecture/design direction to reduce cost and manufacturing complexity

Aid as part of the NPI team in releasing the product to production

May require technical team leadership of design engineering staff, in a matrix environment

QUALIFICATION - KNOWLEDGE/SKILLS - EXPERIENCE:

5+ years of experience as optical engineer working with optical or laser based technology and good understanding of an optical communication link

Excellent analytical skills and familiar with data processing and analytical software (Matlab/Mathematical or similar)

Working programming knowledge in VB/VBA and Matlab

Hands on experience in aligning complex optical systems

Strong communication skills and prior experience with delivering a product from concept through product development to manufacturing

Experience with products that need a thorough understanding of multiple disciplines including electrical, mechanical, optical, and software engineering

Prior experience with delivering a product from concept through product development to manufacturing

The ideal candidate will possess excellent written, verbal, and interpersonal communication skills, is customer-centric, collaborative, and decisive

Opto-Mechanical Engineer

Exciting opportunity for an Opto-Mechanical Engineer. The OME will be responsible for designing, developing, and implementing a variety of simple to complex systems supporting advancement of research. This activity requires a thorough knowledge of optical and mechanical engineering concepts and application. The OME will work collaboratively with research customers and department colleagues. The OME will work on projects from inception at the concept development stage to completion at the product delivery stage, playing a primary role to develop designs and products to meet customer specifications.

Principal Responsibilities:

Designs, develops, assembles, integrates, tests, and optimizes simple to complex opto-mechanical systems for neurobiological research. Applications will include development of systems, sub-assemblies and component parts.

Studies the project concepts, objectives, priorities, and requirements; analyzes user and potential user input.

Identifies and establishes performance requirements involving optical stress, strain, thermal, shock, vibration, acoustic, and radiation inputs and other system parameters and variables as needed.

Collaborates in the development of robust systems that can be distributed and replicated at multiple sites. Solid documentation management skills are required.

Assists with interpretation of requirements from research groups on short and long-term projects. Translates the requirements into mechanical concepts, designs and plans.

Executes designs in a 3D MCAD and optical design environment and performs design analysis, as needed.

Creates detailed drawings and perform document (revision) control.

Estimates up front costs, and then tracks time, effort, and supplies and materials costs to enable proper charges to customers.

Preferred Qualifications:

BS/MS or above. Physics, Mechanical Engineering or equivalent work- related experience required. MS in Physics, Optics, and Optical Engineering strongly preferred.

Experience working in a laboratory environment helpful.

Minimum of 5 years experience in developing Optical/Opto-Mechanical Systems.

Experience working in instruments for neurobiological research, preferred.

Ability to write software using LabView, Matlab, or Visual Studio tools is preferred.

Requires technical aptitude - complete knowledge of optical and mechanical engineering theory, principles and practice.  Experience with design and implementation of instrumentation and/or automation required.

Ability to contribute to and understand core project requirements, which will be of a scientific as well as technical nature, and suggest multiple options.

Ability to perform design work in a 3D CAD modeling environment. Autodesk Inventor® experience preferred.

Ability to perform optical designs in appropriate software. ZEMAX or OSLO experience preferred.

Experience with optical simulation tools required. Tracepro preferred.

Excellent detail drafting skills required. Knowledge of geometric dimensioning and tolerancing preferred

Ability to generate a detailed, costed Bill of Materials including commercially sourced components

Metrology Systems Engineer

New Product Development

The candidate will be responsible for aiding in the development of new and supporting current metrology systems by focusing on system integration, programming, and data analysis.

Lead hardware/software integration of fully custom and commercial-off-the-shelf metrology systems

Investigate improvements to current systems along with new technologies to increase core competencies

Develop proof-of-concept systems (hardware and software)

Work with vendors on requirements building, development strategy, and acceptance testing for production applications and metrology systems

Provide troubleshooting and advanced analysis of metrology data (large data sets, image processing, root cause investigations) for project specific issues

Contribute to acceptance testing of systems (validation, IQ, OQ, PQ)

Key Performance Indicators

Continued innovation in metrology systems related to new product development projects.

Support advanced metrology instrumentation in use by development teams.

Education :

Prefer electrical engineer or optical/mechanical/computer science/computer engineer with focus on systems and instrumentation. BS+5 yrs experience, MS+2 yrs experience.

Experience:

Hardware control (precision motion, cameras, sensors)

Integration of multiple components into working system

C#, LabView, MATLAB

Knowledge of software development life cycle a plus

Computer vision, interferometery, profilometery experience a plus

Excellent communication in written and verbal form

Senior Medical Device Development Engineer

This R&D position will work with the cross-functional core teams through product development process with the main goal of developing and delivering Volcano's new or existing medical device products to market.

Responsibilities:

Design Controls & Methodology

Has mastery over design controls (able to mentor others).

Strong knowledge of and ability to perform Product Development Process activities.

Competent in design approaches and level of rigor - good track record of successful designs.

Basic knowledge and experience with Regulatory requirements associated with design controls.

Design Competencies

Conceptualizes, designs, develops and documents - medium to large scale designs - moderate complexity.

Develops basic catheter /disposable designs, including transducer and optical development and fabrication.

Supports optimization of existing designs.

Ability to create process maps, value stream maps, CAD drawings, and schematics.

Develops and/or guide others in statistical analysis and problem solving. Development of statistical rationale plans for development studies techniques including, but not limited to verification and validation plans, DOEs, Gage R&Rs.

Define, perform and analyze complex linear experiments and complex DOE's.

Performs root cause analysis and implements corrective actions.

Performs development and validation of new test methods.

Direct others in design, building and testing.

Transfers new designs from R&D to production.

Design Documentation Skills

May be a lead on smaller design projects/components, often mentored by a Principal Level Engineer. Participates in research and/or development activities and acquires good laboratory practices (GLP).

Develops strategies and writes advanced technical reports and test plans.

Ability to generate basic test methods and procedures for evaluating designs, processes and products.

Ability to draft documentation for components, designs, processes and tools of moderate complexity.

Basic knowledge and experience in generation of work instructions, preventative maintenance schedules, documentation for components, tooling, and processes of moderate complexity; able to perform operator training.

Assists in organizing technical design reviews and presents relevant sub-sections.

Establishes topologies and architects documentation plans for medium complexity development efforts.

Discipline Leadership Responsibilities

Participates in development efforts as a Medical Device Development Core team representative.

Mentors technicians and junior members of the team.

Scientific Research Responsibilities

Develops and conducts/manages laboratory research. Develops domain knowledge based on, and may contribute to, technical and academic literature.

Executes disposable device performance testing. Develops domain knowledge based on technical and academic literature.

Researches new materials and adapts those materials and equipment into design and production processes.

Technical Communication

Team member or leader within functional area.

Communicates with technical resources, across functional areas, outside vendors and internal customers to resolve conflicts.

Education & Experience:

Bachelors of Science and a minimum of 5 years of relevant work experience; or a Master Degree with a minimum of 3 years of relevant work experience; or a PhD without experience; or equivalent work experience.

(Mechanical Engineering, Material Science, Plastics Engineering, or Biomedical Engineering preferred).

Demonstrate organizational and interpersonal skills working in a cross-functional, regulated environment.

Understanding of theories and principles of domain (preferably in a medical setting).

Skills and Abilities:

Must have familiarity with cardiology catheterization procedures, tools, and terminology.

Ability to work in a team environment to ensure conducive working relationships.

Excellent analytical skills.

Ability to organize and prioritize workflow in order to meet established time frames and schedules.

Assimilate techniques from scientific literature.

Develop intellectual property and support patenting process.

Remain current in discipline and domain.

Support patenting process.

Ability to travel up to 25% (domestic and international locations).

Proficiency in Microsoft Work, Excel, Powerpoint.

Desirable: Solidworks, Statistical Software, Project.

Senior Product Engineer

Rapidly growing medical device company, revolutionizing the industry with a broad suite of technologies that make imaging and therapy simpler, more informative and less invasive. Our products empower physicians around the world with a new generation of analytical tools that deliver more meaningful information-using ultrasound and light as the guiding elements.

Company combining patented MEMs (Micro-Electrical-Mechanical-Systems) devices and proprietary Micro-Optic technology with a highly scalable, automated assembly process to enable the highest performance optical engines for Telecommunications, Industrial, and Medical Imaging applications. We are looking for a successful Senior Product Engineer to join our manufacturing team.

Job Summary:

Provide cross-functional leadership as the "owner" of one or more product lines in Manufacturing

Transition new products from development to manufacturing

Develop systems and specifications to ensure manufacturability

Train operators so as to minimize Engineering involvement in manufacturing

Monitor product quality and performance

Correlate system performance to subassembly specifications and implement controls

Understand product performance at the filter, module, and system levels

Perform root cause analyses on failures

Drive product changes to increase functionality, reduce long term failures, and increase profitability by improving manufacturing yields and throughput

Develop robust processes that can leverage engineering and operations expertise

Responsibilities:

Develop specifications, processes, performance and test requirements for newly-introduced products and new customer configurations

Review Production Test Processes and Data before shipment to ensure compliance with customer specification and develop tools and processes for transition to Operations ownership

Work with Quality and Test to debug Production units, address component quality, and ensure quality of shipments to customers

Drive customer care/responsiveness by coordinating diagnosis of Product RMAs, performance of FMAs, and implementation of Corrective Actions

Work with Sales and Marketing to develop specifications for new product variants

Qualifications:

BS in Engineering or Science, MS desirable

Knowledge and Experience:

Statistical methods for use of SPC, calculating CpKs

Work with MEMS, Lasers, and Micro Optical Assemblies

7-10 years prior experience in manufacturing environment

Skills and Abilities:

Action-oriented and adaptable; strong sense of initiative and urgency

Team leader with excellent communication, influencing, delegating, and coaching skills

Pragmatic; calibrates the solution to the problem at hand

Sr. Mechanical Engineer

Performs a variety of engineering assignments utilizing a wide range of engineering principles.

Works at engineering lead level involving planning development and design of equipment, processes or facilities.

Participates with teams of engineers and/or technicians as necessary to achieve project completion.

Ensures that manufacturing equipment meets company specifications, schedules and budgets.

Facilitates and conducts engineering assignments involving projects of moderate magnitude and scope.

Coordinates projects with sub-contractors from beginning of design process through installation and start-up processes.

Acts as advocate for continuous improvement of technology and processes.

Adheres to environmental policy and procedures and supports department environmental objectives.

Plans, conducts and directs equipment engineering assignments for production support in areas of uptime, cycle time and yield.

Manages multiple projects across various disciplines.

Performs concept analysis and justification of capital projects and manage capital project executions.

Supervises teams of inside and outside designers, consultants and contractors.

Prepares equipment, process, safety and materials specifications and conducts technical analysis of vendor proposals.

Qualifies new equipment and performs vendor and site acceptance testing to meet project objectives.

Provides training to Operations engineers and technicians to operate, troubleshoot and maintain new equipment.

Qualifications:

Bachelors Degree in Mechanical Engineering BSME with a minimum of 4 years engineering experience in working in a manufacturing environment is required for this role.

Experience in equipment development and installation and qualification of machinery and construction is an asset. Project management, is required.

A minimum of 1 years experience working in regulated environment (i.e. Medical Device, Aerospace, Automotive, Silicone chips, etc) is required.

The ability to plan, conduct and direct equipment engineering assignments for production support is required for this position.

This position will require the ability to participate in Cross Functional Teams both internal and external.

Knowledge and understanding and application of principles, concepts and practices of manufacturing engineering is required. 2D & 3D CAD software experience is an asset.

Excellent written and oral communication skills required. Excellent organizational skills required.

Senior Process Engineer

Sr. Process Engineer to perform a variety of engineering assignments utilizing a wide range of engineering principles.

Works at an advanced technical expertise level involving planning development and design of materials, equipment, and/or processes.

Reviews progress and evaluates results of multiple projects across various disciplines.

Coordinates teams of engineers and/or technicians as necessary to achieve project completion.

Facilitates and conducts engineering assignments involving projects of major magnitude and scope.

Takes a leading position in activities involved with outside vendors from beginning of design process through feasibility and start-up processes.

Acts as advocate for continuous improvement of technology and processes.

Adheres to environmental policy and procedures and supports department environmental objectives.

Plans, conducts and directs research, development or engineering assignments.

Manages multiple projects across various disciplines. Project management internally as well as outside vendors (overseas travel necessary).

Performs concept analysis and justification of capital and expense projects for future project development of a medium complexity.

Prepares equipment, process, safety and materials specifications and conducts technical analysis of vendor proposals.

Develops and implements material, equipment and/or process enhancements that will improve product quality and yield, process sustainability and efficiency, and safety.

Performs other related duties as assigned by management.

Basic Qualifications:

Bachelors Degree - Engineering/Material/Natural/Physical Science or equivalent required experience. 5+ years engineering experience in project management and science related field required.

Thorough knowledge and complete understanding and application of principles, concepts and practices of Materials Science; preferably including polymers.

Experience in Operations or Manufacturing is preferred.

Knowledge of process validation is preferred in this role.

Excellent written and oral communication skills required.

Excellent organizational skills required. This position will required travel up to 25%.

Sr. Quality Engineer

Work supporting advanced cardiac imaging catheters and systems development programs.  Responsible for driving design and process quality into new catheter and system products and processes.

Responsibilities:

Participate on the technical teams that successfully develop and launch new advanced cardiac imaging catheters and systems

Own and lead quality assessment and improvement for new advanced cardiac imaging catheters and systems

Determine and Establish use, component and process failure modes, effects, likelihood of occurrence and risk mitigation strategies together with the technical team

Develop and Implement streamlined inspection data collection processes including trend reporting and establishment of quality goals

Interact with Engineering, Marketing, Regulatory, Manufacturing, Purchasing, Clinical, and other departments as appropriate

Education: 

B.S. degree in engineering, preferably mechanical or electrical 

Knowledge and Experience:

8+ years quality engineering experience in the field of medical devices including product development and design controls

Experience with electro-mechanical assemblies, systems and software

Strong analytical skills with a working knowledge of statistical quality methods, sampling methodologies, and Design of Experiments

Knowledgeable of FDA regulations, Quality System Regulations (QSR), and ISO 13485 requirements

Experience in Risk Management, FMEA's, and applying ISO 14971

Track record of success and appropriate cultural fit

Skills and Abilities:

Strong computer skills, generating reports, spreadsheets, presentations.

Strong presentation skills, both written and oral

Practical application of Design of Experiments (DOE)

Ability to work effectively with remote teams and operations

Desirable Qualifications:

Experience with medical device development and manufacturing

Experience with IEC 62304

Experience with IEC 60601-1 3rd edition

Fluidics Systems Engineer

Responsible for the technical leadership in establishing world class advanced fluid handling systems for the company’s product offering. The position will be involved in leadership by contributing in the continuous improvement of the currently offered dispensing and fluid handling systems and joint development integrations of best in class solutions.

ESSENTIAL DUTIES & RESPONSIBILITIES include the following.

Research and Development: Investigate and assess industry approaches of best in class fluid handling / dispensing solutions within the sub-microliter range to help guide and assist in the development of products. Interaction with industry leaders will be required in this capacity. Lead the development of instrumentation fluid handling subsystems.

Subject Matter Expert: Lead the advancement of core fluid handling discipline. Identify opportunities for cost reductions and quality improvements in our fluid handling technologies. Perform engineering analysis and modeling on critical form and function areas. Interact in a professional manner frequently with internal associates, external customers, suppliers and industry leaders. Travel to support customers, Sales, Business Development and Research needs related to fluid mechanics and handling. Mentors and coaches colleague engineers, technicians, field service technicians, and manufacturing personnel.

Technology Application: Develop fluid dispensing and fluid handling devices using new/existing technology within the industry. Apply or recommend the correct fluid handling technology to meet each project’s unique needs. Document and communicate technical solutions for intellectual property requirements.

Project Team Participation: Serve as a project team member, accountable to the project deliverables and schedule. Cooperate with other disciplines in development activities including software design, controls design, electrical design, mechanical design, document control, quality engineering, test engineering, manufacturing and field support services. Promotes / utilizes corporate processes including: design and development, verification and validation, engineering change control, and risk assessment for all designs

Engineer/Scientist Microfluidics and Sensor Technologies

Worldwide developer, manufacturer, and distributor of critical care and hemostasis in vitro diagnostic instruments and related reagents for use primarily in hospital laboratories and hospital point-of-care locations. Our products integrate a wide variety of technologies and disciplines, such as biochemistry, chemical engineering, electrochemistry, electro-optics, software, electronics, mechanical engineering, and microfluidics.

Ideally the candidate should have first project experiences in the development of integrated microsystems for life science applications with a focus on biochemical assay technologies.

Position Summary

This position will provide a key role in developing the pipeline of new products through engineering innovation primarily in the technology area of microfluidic systems for diagnostic laboratory instrumentation and will encompass all aspects of system development.

You will be working in the Dept of Technology Development as a member of multidisciplinary R&D project teams on highly innovative medical instruments.

The position will give the opportunity to work on design, prototyping, and optimization of instrument systems that integrate fluidics, electronics, robotic mechanisms, optics, thermal control, and chemistry analysis.

You will be able to use your engineering education to satisfy product design challenges such as:

Research and develop system and microfluidic architectures for fully automated medical diagnostic instruments, working in a multidisciplinary team.

Design, develop, simulate and evaluate liquid handling systems and sensors.

Design and perform critical experiments and engineering studies relating to system requirements and architecture

The ideal candidate will have a recent degree in micro engineering with a strong background in microfluidics, nanotechnology and a strong understanding of the fundamentals of fluidic theory. You will have a track record of product innovation, used to prototype design and build, ideally with some experience of taking concepts through to full product development.

The position includes technical concept development, systems modeling and the design and characterization of fluidic subsystems for new and existing blood analysis products.

Principal Duties & Responsibilities:

Medical instrument system design and development within a multidisciplinary team

Design and development of liquid handling systems including fluidics and sensor technologies from concept through to manufacture and system integration.

Keep up to date with external developments in the area of microfluidic systems for in vitro diagnostics

Knowledge Requirements:

Comprehensive knowledge of Microfluidic Engineering, coupled with a working knowledge of the other engineering disciplines e.g. mechatronics, sensor technologies and material sciences

Extensive knowledge in materials and component selection.

‘Good team player; able to work in a close-knit teams with design, analysis, integration and test engineers is mandatory.

Minimum Qualifications

MS/PhD in microsystems technology, mechanics, (bio) physics or equal qualification, specialized in microfluidics and nanotechnology with a broad knowledge in mechatronics and material sciences.

Ideally with first project experiences in the development of integrated microsystems for life science applications with a focus on biochemical assay technologies.

Opto-Mechanical/Mechanical Engineer

The major responsibilities of the Instrumentation Engineer include:

Working with R&D personnel to convert a scientific/technical concept to an engineering concept. This include to provide conceptual designs to the specified mechanical problems based on the known solutions, to develop innovative solutions with R&D scientists, and to assess the performance of the proposed solutions and finalize the concept for the engineering design and prototyping,

Working with engineering department to transfer the engineering concept and solution to the product design, review, prototype and finalization,

Testing and evaluating the designed system against the performance specification, and further improving the design with engineering department until the design meets the specification and finalized, helping to develop manufacturing processes and procedures for production.

The qualified candidate must have a Bachelor degree in Mechanical Engineering or Optical Engineering.

Two-years experience in opto-mechanical system related design and analysis,

Understanding of opto-mechanical design principles and solid background in opto-mechanical systems,

Capability in quantitative analysis of mechanical systems using software tools (such as FEA), including stress, deformation, material characteristics and their impacts to the designs,

Being able to use CAD software, preferably UniGraphics, to create 3D models for the conceptualization.

Sr. Researcher - Flexible Electronics

A multidisciplinary R&D laboratory pursuing applied research on new and differentiated materials, devices, advanced algorithms, and systems, with applications to displays, solar energy creation, energy management, biosensors, mobile health, and solid state lighting. Collaborates extensively with product groups and its R&D labs worldwide as well as with universities, US government, and other companies.

Seeking a talented senior researcher to lead a dynamic R&D effort in the area of flexible displays and printed electronics. This employee will drive the development of a strong in-house program in fields including displays, sensors, and lighting. This leadership role will be conducted in collaboration with management and other senior personnel. The employee will set the vision and lead a team of researchers, in addition to his/her own role as technical contributor. S/He will be responsible for technically managing existing projects and will be a key person for generating idea seeds that can provide future technology directions. S/He must have the technical and leadership skills to carry ideas from concept level to feasibility stage, within tight timeframes, and by bringing together other internal and external resources as appropriate. The employee will be expected to multitask, contributing to several projects within the organization. S/He will organize, conduct and interpret experiments and simulations, analyze data, and present actionable information to customers and partners in Japan. The employee will be responsible for project management at the program level and will be expected to act as mentor for junior-level employees. The employee will present pertinent information (progress, results, new proposals) to domestic and international audiences.

Must – Skills / Knowledge Requirements:

Ph.D. degree in Science or Engineering with emphasis on vacuum-free microelectronic materials and devices.

At least 10 years of experience, focused on flexible electronics, process integration and related system design and development.

Excellent leadership skills as evidenced by past record in building and guiding teams towards successful project completions.

Excellent theoretical understanding of solution processed material systems (i.e. organic and inorganic semiconductors), device physics, device integration and device characterization and troubleshooting.

Experience with printing technologies, as they pertain to electronic device fabrication.

Excellent understanding of flexible electronics markets and opportunities.

Past experience with idea-to-technology transfer cycles. Ability to generate and quickly screen new ideas and technologies.

Very strong project management and mentoring skills.

Very strong communication skills. Very strong presentation skills and ability to present at various levels (i.e. technical update, management update, executive update).

Knowledge of the various applications of flexible electronics.