Senior Design Assurance Engineer

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.

• Partner with R&D to drive design assurance activities on product development projects, planning, design requirements & specifications, and technical standards.
• Lead Risk management activities in conjunction with our R&D team
• Lead Design Reviews and manage related records and activities to completion
• Lead Design Transfer activities with R&D and Operations
• Provide feedback on design documentation, planning, user needs, inputs, specifications, verification and validation activities
• Collaborate cross-functionally to plan, execute, and document design controls, risk management, and method/equipment verification/validation, as applicable
• Oversee change management for design changes
• Partner with design teams on human factor study development and execution
• Collaborate with internal and external partners on component qualification
• Maintain Design History and Risk Management Files along with related records for Contraline products (DHF/RMF, DMR, DHR, etc.)
• Provide Quality Engineer and Design Assurance support to Engineering and Operations to ensure risk-based approaches and compliance with applicable regulations
• Drive and support updates to Quality System documentation as needed
• Assist in supplier sourcing and performance management activities
• Support internal, external and supplier audits as needed
• Manage supplier communication and assess for appropriate change management activities

• Strong experience operating within the requirements of FDA 21CFR820 and ISO13485
• Thorough understanding and application of ISO14971 and related subparts throughout the product lifecycle
• Proficiency in process analysis and optimization
• Familiarity with product development best practices including design transfer
• Proficiency with supplier sourcing and ongoing management
• Experienced with statistical significance and its broad application to design, testing, and manufacturing
• Strong interpersonal skills, communication (verbal and written), organizational and project management skills
• Ability to motivate and influence people to ensure enterprise-wide compliance to regulatory requirements
• Committed to a team-oriented approach
• Ability to work both independently and with general direction
• Ability to travel, when requested
• Position based in Charlottesville, Virginia
• Bachelor’s degree or equivalent experience (engineering or technical discipline degree desirable)
• 5+ years experience in a quality role (quality engineer, design assurance, reliability engineer) in medical device
• Previous experience in 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

Contraline offers a comprehensive benefits package including health, dental, 401k and equity opportunities.