Role: R&D Systems Engineer/V&V Engineer - Medical Device

Location: Andover, MA - Onsite

Duration: 6 Months (Possible to extend)

Rate: $50/hr on W2 (Negotiable - No Benefits - No C2C)

***This is a not an IT Systems Engineer role - We need candidates who have worked on Bluetooth/RF-based products. Ideally, someone who has worked on a Closed Loop system from Insulet***

Our Medical Device client is seeking a highly motivated R&D Systems / V&V Engineer to join their team and play a key role in bringing new electromechanical medical devices to market.

In this role, you will be responsible for:

• Supporting new product development (NPD) projects from concept to completion.
• Leading design verification and validation (V&V) activities for electromechanical medical devices.
• Demonstrating a strong understanding of NPD processes, design lifecycle phases, and design qualifications specifications.
• Working with reliability test plans and ensuring compliance with IEC 60601 medical device safety standards.
• Performing gage R&R (repeatability and reproducibility) studies.
• Authoring and executing test protocols for various functionalities.
• Facilitating system integration and implementing product changes during phase-appropriate testing.
• Applying analytical and computational methods like Minitab for data analysis.

To be successful, you will have:

• Experience working on Bluetooth/RF-based products (ideal experience with Closed Loop systems from Insulet is a plus).
• A minimum of a Bachelor’s degree in Systems Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related discipline (preferred).
• A strong understanding of V&V planning and execution methodologies.
• Working knowledge of relevant IEC & ISO standards (60601, 14971, 13485, 21 CFR Part 11) for medical devices.
• Experience with medical device development is a requirement.
• Excellent analytical, problem-solving, and communication skills.
• The ability to work independently and as part of a cross-functional team.