Sustaining Design Quality Engineering Lead

Smith+Nephew; Town of Mansfield (NY); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

401k Matching

Tuition Reimbursement

Medical Insurance

Dental Insurance

Vision Insurance

Paid Holidays

Flexible PTO

Hybrid Work

Job summary

Smith+Nephew in Mansfield, MA is seeking a Quality Leader to drive excellence across the full product lifecycle for Joint Repair products. You will lead Sustaining Design Quality Engineers, influence regulatory submissions, and ensure compliance with FDA QSR, ISO 13485, and ISO 14971 while developing talent.

You will champion robust design control, Mentor engineers, and collaborate with cross-functional teams to deliver safe and effective medical technologies.

Qualifications

• Bachelor of Science in Engineering or related field.
• 5+ years in medical device or regulated environment.
• Strong knowledge of FDA QSR, ISO 13485, ISO 14971.
• Proven leadership experience managing engineering teams.
• Ability to collaborate cross-functionally and communicate at all levels.
• CQE or Lead Auditor certification preferred.

Responsibilities

• Lead Sustaining Design Quality Engineers to support Joint Repair products.
• Drive product lifecycle management and allocate resources to meet business needs.
• Ensure robust design control practices and DHF integrity.
• Review verification/validation, risk management, CAPAs, and design changes.
• Partner with cross-functional teams to ensure safety, performance, and regulatory compliance.
• Support regulatory submissions and represent design control during audits.
• Lead DHF assessments and gap analyses for compliance and continuous improvement.
• Provide technical leadership and mentor quality engineers.
• Influence stakeholders and resolve complex quality/technical/operational challenges.

Skills

Leadership

Quality Leadership

Design Control

Regulatory Knowledge

Cross-functional Collaboration

CQE

Lead Auditor

Education

Bachelor of Science in Engineering

Tools

CQE Tools

Job description

Smith+Nephew in Mansfield, MA is seeking a Quality Leader to drive excellence across the full product lifecycle for Joint Repair products. You will lead Sustaining Design Quality Engineers, influence regulatory submissions, and ensure compliance with FDA QSR, ISO 13485, and ISO 14971 while developing talent.

You will champion robust design control, Mentor engineers, and collaborate with cross-functional teams to deliver safe and effective medical technologies.