Design Quality Engineer (Mansfield, MA)

Davita Inc.; Mansfield (MA); Hybrid; USD 80,000 - 110,000; Full time

Job summary

Join a leading company in the medical device sector as a Design Quality Engineer 2. You will contribute to new product development, ensure compliance with design controls, and enhance product safety through risk management strategies. This hybrid role offers opportunities for professional growth, a competitive salary, and excellent benefits, including a robust 401k matching program and health savings account.

Benefits

401k Matching Program

Paid Time Off

Health Savings Account

Flexible Holidays

Tuition Reimbursement

Qualifications

• 2+ years' experience in the pharmaceutical/medical device industry.
• Familiarity with FMEA and design transfer activities.
• Solid understanding of regulatory requirements.

Responsibilities

• Responsible for ensuring design controls comply with regulations.
• Conduct risk management planning and design verification testing.
• Assist in the preparation for regulatory submissions.

Skills

Risk Management

Design Controls

Quality Assurance

Process Improvement

Education

Bachelor of Science in Engineering

Job description

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

Do you want to work in a collaborative environment that promotes innovation while prioritizing care for each other and our patients? Do you want to develop products that will enable friends and family to live life unlimited? If so, join our Smith+Nephew team as a Design Quality Engineer 2 and be part of a cross-functional team responsible for New Product Development for sports medicine joint repair products.

**This position does not offer visa sponsorship now or in the future**

What will you be doing?

A Design Quality Engineer 2 will be part of a cross-functional team for new product development to deliver safe and effective products to the market by ensuring all aspects of design controls are robust and comply with company polices and governmental regulations. Responsibilities include, but not limited to:

• Design quality engineer on new product development cross-functional core team.

• Responsible for risk management planning, use/design failure mode effects analysis (FMEA), risk control and mitigation and verification of effectiveness.

• Responsible for quality design transfer activities including test method validation / measurement systems analysis and incoming inspection. Support other design transfer activities, including process validations, master validation plans, process summaries, and process failure mode effects analysis (FMEA).

• Responsible for development and release of engineering design documentation, support core team during design reviews and support design history file compilation/audit activities.

• Provide quality input to product user needs, design inputs, design specifications and design outputs (including analysis/definition of critical to quality features).

• Support design verification testing, design validation and usability testing.

• Attend cadaveric labs with customers (sales, marketing, surgeons) to build understanding of user needs and conduct design validation/usability.

• Assists in preparation for regulatory submissions and support sustaining quality with defending design control elements during internal and external audits. Includes leading design control gap assessments (DHF audits).

• Assist in identification and implementation of process improvement initiatives which require cross-functional and multi-site collaboration.

What will you need to be successful?

• Education: Bachelor of Science in Engineering or technically related field

• Experience: 2+ years' experience in the pharmaceutical/medical device industry or related regulated industry.

• Travel Requirements: <10%

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

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

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/Life Balance: PTO, 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

#LI-LS2

#LI-HYBRID

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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