Senior R&D Engineer

Note: We do not hire C2C

Additional position details from the manager are outlined below:

Must have:

• TMV (Test Method Validation)
• Design Verification
• Experience working with fixtures (line machinery)

Top skill sets required

• Development and testing for Phase 2 & Phase 3 stages.
• Creation and testing of characterization protocols.
• Generation and testing of design verification protocols.
• Development and validation of test methods.
• Development of fixtures.
• Analysis of technical specifications and requirements.
• Design modifications and translations into specifications/requirements.
• Testing and qualification of new components.

Main responsibilities/day-to-day activities

• Review and analyze current testing to determine if additional testing is needed.
• Generate testing data to support the testing strategy.
• Develop and validate test methods used to generate test data.
• Possibly review technical specifications and requirement documents.
• Potentially modify current designs to align with newer product technology/requirements.
• Possibly translate new requirements to suppliers..

Target years of experience

• 8-10 years, requiring someone independent and experienced.

Responsibilities may include the following and other duties as assigned:

• Understanding the requirements of cross-functional internal customers.
• Broad application and understanding of technical principles, theories, and concepts in the field.
• Participation in preclinical evaluations.
• Responsible for a subset of product design.
• Development of product specifications, test methods, and equipment; execution of tolerance analysis.
• Creation, review, and approval of protocols/reports.
• Interpretation of test results.
• Working knowledge of DRM and statistics.
• Responsible for subsystems of designs or smaller designs in their entirety.
• Completion of tasks associated with the area of responsibility within the assigned schedule.
• Solid understanding of regulatory indications and requirements, such as IDE, 510k, PMAs, and contribution to assigned sections of submission documents.
• Working knowledge of the internal quality system (e.g., SOPs, DOPs), external quality standards, and statistical methods.
• Experience in design characterization and design selection.

Preferred Qualifications:

• Experience with medical device-based products, processes, and technologies.
• Experience in the medical device/pharmaceutical or other regulated industries.
• Experience in design characterization and design selection.
• Experience with SolidWorks or AutoCAD.
• Proven experience executing product changes regulated by design control and applying the product development process to derivative product lines.
• Mechanical design experience, including modeling for devices and fixtures.
• Prototyping of devices and fixtures through 3D printing and/or machining; catheter device experience.
• Experience in device design verification testing and test development.