Sustaining Design Quality Engineering Manager

Description

The company designs and manufactures medical technology intended to expand what patients can do in their daily lives.

This role is based in Mansfield, MA. You will lead a team of quality engineers responsible for keeping life-enhancing medical devices safe, effective, and compliant while the products stay on the market and continue to change.

The team supports Joint Repair products across their full lifecycle.

Responsibilities

• Lead a team of Sustaining Design Quality Engineers supporting Joint Repair products throughout their lifecycle.
• Manage product lifecycle initiatives and decide how resources are allocated to meet business needs.
• Keep design control practices robust and compliant, and keep the Design History File complete and accurate.
• Review and approve key quality deliverables, including verification and validation, risk management, CAPAs, and design changes.
• Work with cross-functional teams to confirm products meet safety, performance, and regulatory requirements.
• Support regulatory submissions and represent design control activities during audits.
• Lead DHF assessments and run gap analyses to drive compliance and ongoing improvement.
• Provide technical leadership and mentor quality engineers as they grow.
• Influence stakeholders and resolve complex quality, technical, and operational problems.

Requirements

• Bachelor of Science in Engineering or a related technical field.
• 5+ years of experience in the medical device industry or a similarly regulated environment.
• Strong knowledge of FDA QSR, ISO 13485, and ISO 14971.
• Proven experience leading and developing engineering teams.
• Ability to collaborate across functions and communicate clearly at every level.
• Experience running design control activities and solving complex quality problems.
• CQE or Lead Auditor certification preferred.

Conditions

The anticipated base pay range is $96,750.00 to $145,000.00 USD per year.

Actual base pay depends on factors such as job-related knowledge and skills, experience, and geographic location, and is decided case by case.

This is a hybrid role, based in Mansfield, MA.

The company is committed to inclusion and belonging, and encourages applicants of all backgrounds.

Benefits

• Competitive bonus in addition to base pay.
• Medical, dental, and vision coverage.
• Health Savings Account with an employer contribution of $500+ per year.
• 401(k) with matching and a 401k Plus Program, plus a Discounted Stock Purchase Plan.
• Tuition reimbursement.
• Medical leave programs and parental leave, plus fertility and adoption assistance.
• Flexible personal vacation time, paid company holidays, flex holidays, and a paid community service day with 8 hours of volunteer time per year.
• Employee Assistance Program and wellness offerings.
• Discounts on fitness clubs, travel, and more.
• Hands-on, team-customized training and mentorship.