Sustaining Design Quality Engineering Manager

Smith+Nephew is hiring a Sustaining Design Quality Engineering Manager. It pays $97k-$145k a year and Level rates it ; you can apply on Smith+Nephew.

Level's read on this job

Level rates this role Little AI ●○○○: aI is not part of the work.
Level classes it as a senior role.
Smith+Nephew has 346 other open roles on Level.

AI in this role

Life. Unlimited. At Smith+Nephew 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+Nephew 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.

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How we rate this

Sustaining Design Quality Engineering Manager at Smith+Nephew rates 37 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.