Sustaining Design Quality Engineering Manager

Regulatory Jobs; Mansfield (MA); Híbrido; USD 97.000 - 145.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Tuition Reimbursement

Paid PTO

Paid Holidays

Volunteer Time

Wellness Program

Descripción de la vacante

Smith+Nebhew is seeking a Quality Engineering leader based in Mansfield, MA to guide Sustaining Design Quality Engineers across the product lifecycle, ensuring robust design controls and DHF integrity. You will direct regulatory submissions and collaborate with cross-functional teams to meet safety and regulatory standards.

The role focuses on advancing lifecycle quality, risk management, and continuous improvement while mentoring engineers and influencing stakeholders.

Formación

• Bachelor of Science in Engineering or a related technical field.
• 5+ years of experience in the medical device industry or similarly regulated environment.
• Strong knowledge of FDA QSR, ISO 13485, and ISO 14971.
• Proven leadership experience managing and developing engineering teams.
• Ability to collaborate cross functionally and communicate effectively at all levels.

Responsabilidades

• Lead Sustaining Design Quality Engineers to support Joint Repair products across their lifecycle.
• Drive product lifecycle management initiatives and allocate resources to meet business needs.
• Ensure robust design control practices and maintain 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 represent design control during audits.
• Lead DHF assessments and gap analyses for compliance and continuous improvement.
• Provide technical leadership and mentorship to develop quality engineering talent.
• Influence stakeholders and resolve complex quality, technical, and operational challenges.

Conocimientos

Leadership

Regulatory Knowledge

Cross-functional Collaboration

Communication

Mentorship

Quality Engineering

Educación

Bachelor of Science in Engineering

CQE or Lead Auditor certification preferred

Descripción del empleo

Life. Unlimited. At Smith+Nebhew we design and manufacture technology that takes the limits off living.

Are you a quality leader passionate about driving excellence across the full product lifecycle? This is an opportunity to lead a high performing engineering team, influence strategic initiatives, and ensure life enhancing medical technologies remain safe, effective, and compliant. Based in Mansfield, MA, you will play a critical role in sustaining innovation while shaping quality practices across the organization.

What will you be doing?

• Leading a team of Sustaining Design Quality Engineers to support Joint Repair products across their lifecycle
• Driving product lifecycle management initiatives and strategically allocating resources to meet business needs
• Ensuring robust and compliant design control practices, maintaining Design History File integrity
• Reviewing and approving key quality deliverables including verification and validation, risk management, CAPAs, and design changes
• Partnering with cross functional teams to ensure products meet safety, performance, and regulatory requirements
• Supporting regulatory submissions and representing design control activities during audits
• Leading DHF assessments and conducting gap analyses to drive compliance and continuous improvement
• Providing technical leadership and mentorship to develop quality engineering talent
• Influencing stakeholders and resolving complex quality, technical, and operational challenges.

What will you need to be successful?

• 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 leadership experience managing and developing engineering teams
• Ability to collaborate cross functionally and communicate effectively at all levels
• Experience driving design control activities and solving complex quality challenges
• CQE or Lead Auditor certification preferred

The anticipated base compensation range for this position is $96,750.00 to $145,000.00 USD annually.

The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, and geographic location. Compensation decisions are dependent upon the facts and circumstances of each position and candidate.

In addition to base pay, we offer competitive bonus and benefits, including medical, dental, and vision coverage, 401(k), tuition reimbursement, medical leave programs, parental leave, generous PTO, paid company holidays, 8 hours of volunteer time annually, and a variety of wellness offerings such as EAP.

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).

Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement

Work/Life Balance: Flexible Personal Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day

Your Wellbeing: Medical, Dental, Vision, Health Savings Account Employer Contribution of $500+ annually, Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

Flexibility: Hybrid Work Model for most professional roles

Training: Hands On, Team Customized, Mentorship

Extra Perks: Discounts on fitness clubs, travel and more

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Smith+Nebhew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.