Research And Development Engineer

Job Title: R&D Mechanical Engineer

Duration: 6 Months (Possible extension)

Hybrid Role

Responsibilities:

• Will support integration of the acquired company’s Design History File (DHF) to compliance, with primary emphasis on design outputs, design verification prerequisite deliverables and execution, test method development and validation, technical problem-solving and issue resolution, and DHF documentation.
• Utilize your background in mechanical and/or systems design, design verification, test method development and validation, verification testing, engineering documentation, and technical problem-solving.
• Successfully completing engineering work in one or more of the following: design outputs; design verification prerequisite deliverables and execution
• Design Verification test method development and validation
• Essential Design Output identification; System/Subsystem/Component requirements tracing; and Design FMEA
• Providing input to project goals and progress and recommending appropriate revisions.
• Communicating progress, risks, and trade-offs of technical deliverables to R&D technical leadership and recommending revisions as needed.
• Work is expected to result in efficient and effective integration of medical device technologies to the portfolio.
• Providing technical problem-solving and issue resolution, including assessing the feasibility and soundness of alternative engineering processes, products, equipment, or documentation approaches.
• Completing clear and concise DHF and engineering documentation, including protocols, reports, rationales, design outputs, and verification-related deliverables.
• Demonstrating Technology Development and Product Development system knowledge through delivery of high quality, high impact deliverables.

Education/Experience:

• BS or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
• 4 yrs of Medical Device engineering or related experience with bachelor’s degree, or 2 yrs with Master’s
• Strong mechanical and/or systems engineering and problem-solving skills and attention to detail
• Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources

Preferred:

• Familiarity with IEC 14708 and 45502 Active Implantable standards
• Familiarity with IEC 60601 Medical Electrical Equipment standards
• Experience with statistical techniques (Gauge R&R, Process Capabilities Studies) and Minitab
• Experience in requirements tracing applications like Cognition Cockpit
• Experience in single-use device or active implantable test methods and test method validation