Lead Design Assurance Quality Engineer

About the role

The Lead Design Assurance Quality Engineer is a core member of product development teams, representing Quality on new medical device projects and change initiatives. This role drives quality outcomes across the product lifecycle, collaborates with cross‑functional teams, and applies project‑management principles to coordinate quality activities.

Key responsibilities

• Guide cross‑functional teams in applying design controls in line with global medical device regulations.
• Lead design verification, validation, process verification and validation for new products and major changes.
• Facilitate Design FMEA, participate in Process FMEA reviews and conduct risk assessments per ISO 14971.
• Maintain Usability Engineering Files and support specification, test method, clinical, verification and validation programs.
• Partner with manufacturing sites, suppliers and QA functions for new product introductions.
• Apply statistical techniques (ANOVA, DOE, hypothesis testing, control charts, regression, survival analysis, MSA, acceptance sampling) to qualify products and processes.
• Review and approve pre‑production and first‑article inspections.
• Mentor colleagues on quality engineering tools and best practices.

Required profile

• Strong background in medical device quality engineering and design assurance.
• Experience with regulatory requirements, design controls and risk management (ISO 14971).
• Proven ability to lead quality activities within cross‑functional project teams.
• Excellent analytical, communication and documentation skills.

Required skills

• ANOVA
• Design of Experiments (DOE)
• Hypothesis testing
• Process capability studies
• Control charts
• Regression analysis
• Survival analysis
• Measurement system analysis (MSA)
• Acceptance sampling
• Excel
• SAP
• FMEA