Senior Product Development Engineer

Contraline • Charlottesville, VA

3h • Onsite

About The Position

The Senior Product Development Engineer will support the design and development of Class II and Class III medical devices and their associated delivery systems. This role requires strong analytical and technical skills, adherence to Quality System Regulations, and the ability to operate independently in a fast‑paced, hands‑on environment. This is a full‑time, on‑site position.

Requirements

• B.S., M.S., or Ph.D. in Biomedical, Mechanical, Chemical Engineering, or related field
• 5+ years in Class II/III medical device product development or manufacturing
• Experience with Process development & validation (IQ/OQ/PQ)
• Experience with Design Controls and DHF documentation
• Experience with Verification & Validation testing and protocol development
• Experience with Applied statistics (DOE, regression, capability analysis)
• Experience with Risk analysis (FMEA, hazard analysis, fault tree)
• Experience with Manufacturing transfer and supplier interaction
• Experience with ISO 13485 and FDA QMSR
• Strong communication, documentation rigor, and cross‑functional collaboration
• Self‑starter with strong problem‑solving skills
• Ability to work on‑site in lab and controlled manufacturing environments (PPE/cleanroom gowning, hands‑on work, lifting up to 25 lbs.)

Nice To Haves

• Design transfer for sterile/aseptic processes
• Class II/III implantable devices or combination products

Responsibilities

• Assist with the design and development of polymer implantable devices and delivery device tools through design development to manufacturing, consistent with medical devices regulatory and quality requirements.
• Own development and execution of V&V strategies, including protocol authorship, design traceability, and establishment of clear, testable acceptance criteria.
• Design and execute experimental benchtop studies and statistical analyses (e.g., DOE, capability studies) to assess the impact of processing parameters on product performance and variability.
• Interpret data and communicate findings to cross‑functional teams.
• Lead design transfer activities from R&D into manufacturing environments, including preclinical and clinical builds, with a focus on aseptic/sterile processing and process consistency.
• Collaborate with Operations, Quality, and external partners to ensure robust, scalable processes.
• Contribute to design controls and risk management activities, including verification, validation, and FMEAs.
• Manage relevant vendor relationships, including component vendors and external testing.
• Continuously monitor compliance with FDA, ISO 13485, and design control requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 1-10 employees