Contraline is a medical device company based in Charlottesville, Virginia. We are developing the first long-lasting, non-hormonal, and reversible male contraceptive. Our mission is to improve the reproductive health of patients worldwide by commercializing state-of-the-art medical products.

The Senior Product Development Engineer will support the design and development of Class II and Class III medical devices and their associated delivery systems.

• 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.

• 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)
• Design Controls and DHF documentation
• Verification & Validation testing and protocol development
• Applied statistics (DOE, regression, capability analysis)
• Risk analysis (FMEA, hazard analysis, fault tree)
• Manufacturing transfer and supplier interaction
• ISO 13485 and FDA QMSR
• Design transfer for sterile/aseptic processes (preferred)
• Class II/III implantable devices or combination products (preferred)
• 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.)

Apply here: https://ats.rippling.com/contraline-careers/jobs