Sustaining Design Quality Engineering Manager (Hybrid)

Smith & Nephew; Mansfield (MA); Hybrid; USD 120,000 - 190,000; Full time

Benefits offered by this job

401(k) Matching Program

Tuition Reimbursement

Paid Holidays

Paid Time Off

Employee Wellness Program

Job summary

Smith+Nephew in Mansfield, MA is seeking a Sustaining Design Quality Engineering Manager to lead a high-performing team responsible for sustaining design quality across Joint Repair products. You will drive lifecycle initiatives, allocate resources, and ensure robust design control practices with DHF integrity.

You will review and approve key quality deliverables including V&V, risk management, CAPAs, and design changes while partnering with cross-functional teams to meet safety, performance,

Qualifications

• BS in Engineering or related field.
• 5+ years in medical devices or regulated environments.
• Strong knowledge of FDA QSR, ISO 13485, and ISO 14971.
• Proven leadership experience developing engineering teams.
• CQE or Lead Auditor certification preferred.

Responsibilities

• Lead Sustaining Design Quality Engineers across Joint Repair products.
• Drive lifecycle management initiatives and resource planning.
• Maintain robust, compliant design control and DHF integrity.
• Review/approve verification, validation, risk management, CAPAs, and changes.
• Collaborate cross-functionally to meet safety, performance, and regulatory requirements.
• Support regulatory submissions and audits; lead DHF gap analyses.
• Provide technical leadership and mentor quality engineers.

Skills

Cross-functional leadership

Regulatory knowledge

Design controls

Quality mindset

Mentorship

Education

Bachelor of Science in Engineering

Tools

CAPA system

Risk management software

Document control tools

Job description

Smith+Nephew in Mansfield, MA is seeking a Sustaining Design Quality Engineering Manager to lead a high-performing team responsible for sustaining design quality across Joint Repair products. You will drive lifecycle initiatives, allocate resources, and ensure robust design control practices with DHF integrity.

You will review and approve key quality deliverables including V&V, risk management, CAPAs, and design changes while partnering with cross-functional teams to meet safety, performance,