Senior Design Assurance Engineer

Website Contraline

About Contraline

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.

Job description

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

What you’ll do
  • 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
What you’ll need
  • 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.

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