Design Quality Engineering Manager - Sustaining Med Devices

smithnephew; Mansfield (MA); Hybrid; USD 110,000 - 170,000; Full time

Benefits offered by this job

Hybrid work model

Mentorship program

Wellbeing benefits

Volunteer time

Job summary

Smith+NePhew in Mansfield, MA is seeking a quality leader to drive excellence across the full product lifecycle. You will lead a high-performing engineering team, influence strategic initiatives, and ensure life-enhancing medical technologies remain safe, effective, and compliant.

As part of the role, you will strengthen design control practices, maintain Design History File integrity, and support regulatory submissions and audits while mentoring engineers and resolving complex quality

Qualifications

• Bachelor of Science in Engineering or related field
• 5+ years in medical device or similarly 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
• Experience driving design control activities and solving complex quality challenges
• CQE or Lead Auditor certification preferred

Responsibilities

• Lead sustaining design quality engineers for Joint Repair products across their lifecycle
• Drive product lifecycle management initiatives and strategically allocate resources
• Ensure robust and compliant design control practices, maintaining DHF integrity
• Review and approve verification/validation, risk management, CAPAs, and design changes
• Partner with cross functional teams to meet safety, performance, and regulatory requirements
• Support regulatory submissions and representing design control activities during audits
• Lead DHF assessments and conducting gap analyses to drive compliance and continuous improvement
• Provide technical leadership and mentorship to develop quality engineering talent
• Influence stakeholders and resolve complex quality, technical, and operational challenges

Skills

Leadership

Cross-functional

Quality systems

Regulatory knowledge

Communication

Mentoring

Problem solving

Education

Bachelor of Science in Engineering

Job description

Smith+NePhew in Mansfield, MA is seeking a quality leader to drive excellence across the full product lifecycle. You will lead a high-performing engineering team, influence strategic initiatives, and ensure life-enhancing medical technologies remain safe, effective, and compliant.

As part of the role, you will strengthen design control practices, maintain Design History File integrity, and support regulatory submissions and audits while mentoring engineers and resolving complex quality