Sr​/Principal Design Assurance Engineer

Principal Design Assurance Engineer

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.

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.

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.

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.

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.

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.

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

Solid Works proficiency, a plus

Strong statistics + experience with statistical software