West Leland Group · 1 day ago
Manager / Principal Design Quality Engineer
Nashville Metro
Full-time
Onsite
Senior Level, Lead/Staff
6+ years expWest Leland Group is partnering with a fast-growing medical device organization to hire a Manager / Principal Design Quality Engineer who will play a key role in shaping device quality across both new product development and external manufacturing. The role involves supporting device quality initiatives, leading risk management activities, and collaborating with R&D to ensure compliance with regulatory expectations.
Staffing & Recruiting
Hiring Manager
Jack Feeley
Responsibilities
Support device quality initiatives spanning new product development, design updates, and sustaining engineering
Partner with R&D to guide Design Control activities and ensure development projects meet regulatory and quality expectations
Shape verification and validation approaches, coordinating test planning, execution, and interpretation
Lead device risk management activities including hazard analyses and FMEAs
Serve as a technical resource on Six Sigma / process improvement, statistical methods including DOE, sampling plans, Gage R&R, tolerance stack-ups, and capability analysis
Provide quality support to external manufacturing partners to ensure consistent performance and compliance
Lead investigations into product performance issues, complaints, and nonconformances and ensure effective actions
Oversee quality system actions tied to product performance, change management, and continuous improvement within the eQMS
Collaborate cross-functionally to facilitate smooth transfer of products from development into commercial manufacturing
Act as a player-coach, remaining hands-on in design quality execution while mentoring junior engineers
Qualification
Required
Bachelor's degree in Engineering, Science, or related technical discipline
6+ years of experience in medical device quality engineering, including Design Controls within ISO 13485 environments
Strong grounding in Design Controls and product development
Experience planning or reviewing validation strategies, protocols, and reports
Demonstrated success leading investigations and closing CAPAs
Experience supporting or influencing external partners (CMOs, suppliers, contract manufacturers)
Familiarity with statistical tools including DOE, sampling plans, Gage R&R, and process capability
Clear communication and influencing skills across R&D, Quality, Operations, and external teams
Proficiency with Microsoft Excel and Minitab
Preferred
CQE or Six Sigma certification
Experience supporting FDA or notified body audits
Exposure to plastic injection molding, assembly, or component manufacturing
Experience supporting Design Transfer into commercial manufacturing environments
Benefits
Competitive compensation and benefits
Company
West Leland Group
West Leland Group is a specialized search firm focused on recruiting Quality Engineering, Quality Systems, and Regulatory Affairs talent within the Medical Device industry.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase