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.
Your Role With The Company:- 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
- BiocompatibilityShelf life
- Equipment qualification
- SterilizationPackaging 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 QASPC / 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.
- 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 + DHFVerification/validation, process validation, and statistically valid testing
- Regulatory/QMS expectations (ISO, FDA)
- Exposure to: biocompatibility, human factors, electrical safety, sterilizationASQ CQE certification
- SolidWorks proficiency, a plus
- Strong statistics + experience with statistical software
