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.

Contraline is seeking a Design Assurance Engineer to actively manage Design Controls and Risk Management activities for our medical devices.

• Work with Contraline’s product development team to plan and execute compliant, risk-based approaches to procedures, plans, design requirements & specifications, technical standards, and equipment verification/validation and verification and validation activities
• Represent Quality and Design Assurance in engineering/R&D core team meetings
• Establish and maintain Design History and Risk Management Files along with related records for Contraline products in our Quality System (DHF/RMF, DMR, DHR, etc)
• Partner with R&D to develop and provide feedback on all design documentation including user needs, inputs, product specifications, verification and validation plans and reports
• Provide Quality Engineer and Design Assurance support to Engineering to ensure compliance with applicable regulations and enable ongoing innovation
• Lead Risk management activities in conjunction with our R&D team
• Lead Design Reviews and manage related records, and activities to completion
• Oversee change management for design changes
• Partner with design teams on human factor study development and execution
• Drive and support updates to Quality System documentation outside of design controls and risk management as needed
• Support internal and external audits
• Collaborate with R&D team and external partners on component qualification, as well as equipment verification/validation

• Demonstrated proficiency in medical device Quality Management System regulations, standards and guidance including ISO 13485, FDA 21 CFR 820 and relevant documents
• Thorough understanding and application of EN ISO 14971, 21CFR820.30 and related subparts.
• Bachelor's degree or equivalent experience (engineering or technical discipline degree desirable)
• 3+ years' experience in a quality role (quality engineer, design quality engineer)
• Previous responsibility for design controls/risk management and related records, specification writing, statistical analysis, report writing, design transfer and medical device design reviews.
• Demonstrated experience and responsibility for compliance for FDA, MDD and ISO regulations
• ASQ Certification preferred