Sr/Principal Design Assurance Engineer

Custom Search Inc.; Minneapolis (MN); On-site; USD 120,000 - 160,000; Full time

Job summary

Custom Search Inc. seeks a Principal Design Assurance Engineer to lead design quality from concept to transfer for a medical device program. You will guide cross-functional teams, drive risk-based decisions, and ensure audit-ready DHF and strong V&V plans.

This role partners with R&D, QA, Ops, and Marketing to meet ISO/FDA expectations while maintaining innovation velocity. The ideal candidate will bring 10+ years in design assurance, proficiency with ISO 14971, design controls, DHF, and a track

Qualifications

• BS in Engineering or equivalent combination of education and experience.
• 10+ years of design assurance/quality engineering in medical devices.
• Strong knowledge of ISO 14971, design controls, DHF and regulatory expectations.
• Experience with complex systems (mechanical/electrical/software).
• ASQ CQE certification is a plus; proficiency in SolidWorks beneficial.

Responsibilities

• Serve as the Quality representative on cross-functional development teams from design through transfer and post-launch improvements.
• Own product safety and quality across design and process development, ensuring alignment with inputs/outputs and regulatory requirements.
• Maintain an audit-ready DHF including structure, deliverables, and procedures.
• Lead risk management activities (plans, analyses, FMEAs, reports) across the lifecycle.
• Drive alignment on risk controls, traceability, and documentation for regulatory reviews.
• Provide QA support across all development phases including design verification/validation and testing.
• Partner with R&D on test plans, data analysis, specs, and acceptance criteria.
• Support CAPA, nonconformances, and supplier qualifications; drive root cause analysis.

Skills

Design Assurance

Risk Management

Verification

DHF

ISO 14971

Education

BS in Engineering

Tools

SolidWorks

Statistical software

Job description

Our early-stage medical device client is adding a Principal Design Assurance Engineer to the team.You’ll be the Design Quality voice from early concept through design transfer—helping teams build safe, compliant products without slowing innovation. This is a high-impact, cross-functional role partnering with R&D, Clinical, Ops, and Marketing to drive risk-based decision making, strong verification/validation, and a clean path to regulatory success.

If you like owning the “how do we prove it?” work—risk, requirements, DHF, V&V strategy, usability, biocomp, sterilization, packaging/labeling—this is your lane.

Your role with the company:

Design Assurance leadership (end-to-end)

• Serve as the Quality representative on cross-functional development teams from early design through design transfer and ongoing product/process improvements.

• Own product safety + quality across design and process development, ensuring compliance with design inputs/outputs, ISO/FDA expectations, and applicable regulatory requirements.

• Maintain a strong, audit-ready Design History File (DHF): structure, deliverables, updates, and associated procedures.

Risk management (ISO 14971)

• Lead risk management activities across the lifecycle: risk management plans, user risk analysis, FMEAs, and risk management reports.

• Drive alignment on risk controls, traceability, and documentation that stands up to review.

Verification, validation, and technical documentation

• Provide Quality Engineering support across all development phases.

• Review/approve key deliverables tied to:

  • Design verification & validation

  • Process validation

  • Test method validation

  • Usability/human factors

  • Biocompatibility

  • Shelf life

  • Equipment qualification

  • Sterilization

  • Packaging and labeling

• Partner with R&D on test plans, data analysis, specs, acceptance criteria, and statistically sound verification methods.

Quality systems + continuous improvement

• Support the business in solving manufacturing and product-quality problems using strong quality tools (RCA, risk analysis, FMEA, DOE, statistical methods).

• Develop/improve product assurance systems including:

  • Receiving/in-process QA

  • SPC / process capability

  • Calibration & preventive maintenance

  • Nonconforming materials

  • Lot release testing & finished goods controls

• Track and report performance metrics (defects, NCMR trends, etc.) and translate data into action.

Compliance + audits + CAPA

• Ensure QMS compliance with 21 CFR 820 (QSR) and ISO 13485 (Canada/Europe).

• Help set strategic quality goals aligned to corporate objectives.

• Support internal audits, special investigations, and supplier qualification/audits.

• Manage customer complaint, NCMR, and CAPA processes; lead or participate in root cause analysis and implementation.

Desired Profile:

• BS in Engineering (or equivalent combination of education/experience)

• 10+ years of relevant experience in design assurance / quality engineering in the medical device industry

• Ideal candidate will have experience with complex systems such as mechanical/electrical/software

• Strong working knowledge of:

  • ISO 14971 risk management

  • Design controls + DHF

  • Verification/validation, process validation, and statistically valid testing

  • Regulatory/QMS expectations (ISO, FDA)

• Exposure to: biocompatibility, human factors, electrical safety, sterilization

• ASQ CQE certification

• SolidWorks proficiency, a plus

• Strong statistics + experience with statistical software