Principal Design Assurance Engineer

Mobia
United States
Workplace: OnsiteFull timeUSD 110,000 - 160,000 annuallyFunction: Design (Product/UX/UI/Visual)Experience: 10+ yearsEducation: bachelorsSkills: ["Communication","Leadership","Analytical problem-solving","Independent judgment","Organizational/time management"]

Lead design assurance for new hardware and electrical medical device products, ensuring compliant transfer into manufacturing. Maintain Design History Files (DHF) and design risk management documentation, and serve as a technical bridge between Design Engineering and Quality. Support post-market sustaining activities including failure analysis, design changes, supplier performance, and complaint investigations. Drive design verification/validation, root cause and corrective actions, and provide subject-matter expertise in design controls, risk management, and regulatory standards.

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Mobia
Mobia
1 month ago

Principal Design Assurance Engineer

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Last checked: 1 hour agoStatus: Live

Job Summary

Lead design assurance for new hardware and electrical medical device products, ensuring compliant transfer into manufacturing. Maintain Design History Files (DHF) and design risk management documentation, and serve as a technical bridge between Design Engineering and Quality. Support post-market sustaining activities including failure analysis, design changes, supplier performance, and complaint investigations. Drive design verification/validation, root cause and corrective actions, and provide subject-matter expertise in design controls, risk management, and regulatory standards.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Design (Product/UX/UI/Visual)
Seniority: Mid level

Key Responsibilities

  • •Provide design assurance leadership for new hardware and electrical medical device product design and development through transfer into manufacturing.
  • •Maintain lifecycle documentation including Design History Files (DHF) and design risk management materials.
  • •Lead and support compliant development, verification, validation, and transfer activities, including design reviews and phase-gate reviews.
  • •Support post-market sustaining activities such as failure analysis, design change development/implementation, supplier performance evaluation, and complaint investigations.
  • •Lead root cause investigations, develop corrective actions, verify effectiveness, and support audits/regulatory inspections.

Pay and Benefits

Salary: USD 110,000 - 160,000 annually
Perks:Health InsuranceDentalVision401kPaid LeaveFsa

Key Requirements

  • •Bachelor’s degree in Electrical, Biomedical, Mechanical Engineering, or related field with 10+ years of progressive experience (or equivalent education/experience).
  • •Apply hardware and electrical design controls in regulated industries, including quality engineering and lifecycle documentation (e.g., DHF).
  • •Experience with risk management and new product development, including verification and validation testing.
  • •Strong knowledge of applicable regulations and standards including FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, IEC 61010, ISO 10993, and EU MDR.
  • •Strong communication and demonstrated ability to lead technical teams through collaboration and influence.
Experience:10+ yearsMedical deviceMedtechRegulated industries
Education:Bachelor's
Skills:CommunicationLeadershipAnalytical problem-solvingIndependent judgmentOrganizational/time management
Tech Stack:DHFCAPAComplaint investigationsNonconformance dispositionMicrosoft OfficeFDA 21 CFR Part 820ISO 13485ISO 14971IEC 60601IEC 61010ISO 10993EU MDRDesign verificationDesign validation

Company Brief

Mobia
MCIM 24x7 provides round-the-clock IT infrastructure monitoring, managed services, network and security support, and cloud infrastructure management for businesses seeking continuous operational uptime and technical support.
Industry: Professional Services
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