West Leland Group ยท 1 day ago
Manager, Design Quality Engineering
Nashville Metro
Full-time
Onsite
Mid, Senior Level
7+ years expWest Leland Group is partnering with a fast-growing medical device organization to hire a Manager, Design Quality Engineering who will play a key role in shaping device quality across both new product development and external manufacturing. The ideal candidate will support device quality initiatives, partner with R&D during Design Control, and lead device risk management activities.
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
Apply Six Sigma and structured problem-solving to improve process capability and reduce variation
Collaborate cross-functionally to facilitate smooth transfer of products from development into commercial manufacturing
Participate in internal audits, supplier oversight activities, and regulatory inspections
Act as a player-coach, guiding junior engineers while remaining hands-on in execution
Qualification
Required
Bachelor's degree in Engineering, Science, or related technical discipline
7+ years of experience in medical device (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
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