Design Quality Engineer (Andover, MA)

Smith & Nephew; Andover (MA, MN); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in the medical technology field is seeking a Design Quality Engineer 2 to support new product development in the Sports Medicine franchise. This role involves collaboration with cross-functional teams to ensure compliance with quality standards and effective risk management practices. Ideal candidates will have a bachelor's degree in engineering and relevant experience in quality engineering within regulated industries.

Benefits

401k Matching Program

Tuition Reimbursement

Paid Community Service Day

Medical, Dental, Vision coverage

Health Savings Account (Employer Contribution)

Parental Leave

Fertility and Adoption Assistance Program

Discounts on fitness clubs and travel

Qualifications

• 2-5 years' quality engineering experience in medical device or comparable regulated industry.
• Risk Management per ISO 14971 preferred.
• Medical device software development per IEC 62304 preferred.

Responsibilities

• Support new product development and implementation of new hardware/software products.
• Participate on cross-functional core team and provide quality input.
• Assist in preparation for regulatory submissions and provide support during audits.

Skills

Time management

Effective Collaboration

Effective written/oral communication skills

Accountability

Education

Bachelor's in engineering or a technically related field

Job description

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

Reporting into the Quality Department, the Design Quality Engineer 2 has responsibility for providing Quality Engineering support to New Product Development (NPD) activities for Hardware/Software products in the Sports Medicine franchise. Works collaboratively with project team members to develop and manage project plans and activities related to new product development. The Design Quality Engineer 2 is responsible for supporting the execution of design control and risk management activities for assigned projects in accordance with internal procedures and applicable standards/ regulations.

**This position does NOT offer any type of visa sponsorship now or in the future**.

What will you be doing?

• Support new product development and implementation of new hardware/software products via development of overall risk management file. Risk management planning, use/design/software failure mode effects analysis (FMEA), risk control and mitigation and verification of effectiveness.

• Support new product development of hardware/software products by participating on cross-functional core team. Provide quality input to product user needs, design inputs, software requirements, software detailed design specifications and design outputs (including analysis/definition of critical to quality features)

• Support design verification testing, design validation and usability testing. Support as needed software and/or system verification/validation testing activities including protocol and use case development, test execution and report writing.

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

• Under Quality Team supervision support, manufacturing quality activities including measurement systems analysis, incoming inspection, control plans, process summaries and process failure mode effects analysis (FMEA).

• Assist in preparation for regulatory submissions and provide support during audits and inspections.

• Improve knowledge of design controls, risk management, testing, statistics, Design Verification and Validation, Measurements Systems, applicable Quality System standards/regulations.

What will you need to be successful?

• Education: bachelor's in engineering or a technically related field.

• Experience: 2-5 years' quality engineering experience in medical device or comparable regulated industry.

• Risk Management per ISO 14971 preferred

• Medical device software development per IEC 62304 preferred

• ISO 13485 preferred

• Time management, ability to plan and schedule multiple projects and tasks

• Effective Collaboration with cross functional teams

• Effective written/oral communication skills

• Accountability

• Travel Requirements: <10%

You. Unlimited

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

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on 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

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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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