Design Quality Engineer (Andover, MA)

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

Job summary

A leading company in the medical device industry is seeking a Design Quality Engineer 2 to provide quality engineering support for new product development in the Sports Medicine franchise. This role involves collaborating with project teams, managing project plans, and ensuring compliance with design control and risk management standards. Candidates should have a Bachelor's degree in engineering and 2-5 years of relevant experience.

Benefits

401k matching

Stock options

Tuition reimbursement

PTO

Holidays

Flex holidays

Community service days

Medical, dental, vision

HSA

Employee assistance

Parental leave

Fertility and adoption support

Hybrid work model

Hands-on team mentorship

Discounts on fitness, travel, and more

Qualifications

• 2-5 years of quality engineering experience in medical devices or a regulated industry.
• Knowledge of risk management per ISO 14971 and medical device software development per IEC 62304 preferred.
• Understanding of ISO 13485 preferred.

Responsibilities

• Support new product development and implementation of new hardware/software products.
• Participate in cross-functional core teams to support product development.
• Support design verification and validation testing.

Skills

Time Management

Planning

Multitasking

Collaboration

Communication

Accountability

Education

Bachelor's degree in engineering or a 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?

1. Support new product development and implementation of new hardware/software products via development of overall risk management file, including planning, FMEA, risk control, mitigation, and verification.
2. Participate in cross-functional core teams to support hardware/software product development, providing quality input on user needs, design inputs, software requirements, and design outputs.
3. Support design verification and validation testing, including protocol and use case development, execution, and reporting.
4. Develop and release engineering design documentation, support design reviews, and assist with design history file activities.
5. Assist in manufacturing quality activities such as measurement systems analysis, incoming inspection, control plans, and FMEA.
6. Prepare for regulatory submissions and support audits and inspections.
7. Enhance knowledge of design controls, risk management, testing, statistics, and applicable standards/regulations.

What will you need to be successful?

• Bachelor's degree in engineering or a related field.
• 2-5 years of quality engineering experience in medical devices or a regulated industry.
• Knowledge of risk management per ISO 14971 and medical device software development per IEC 62304 is preferred.
• Understanding of ISO 13485 is preferred.
• Strong time management, planning, and multitasking skills.
• Effective collaboration, communication, and accountability.
• Travel availability.

You. Unlimited

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

Inclusion, Diversity and Equity

We are committed to welcoming and celebrating diversity. Learn more about Employee Inclusion Groups.

Other reasons why you will love it here!

• Your Future: 401k matching, stock options, tuition reimbursement.
• Work/Life Balance: PTO, holidays, flex holidays, community service days.
• Your Wellbeing: Medical, dental, vision, HSA, employee assistance, parental leave, fertility and adoption support.
• Flexibility: Hybrid work model.
• Training: Hands-on, team mentorship.
• Extra Perks: Discounts on fitness, travel, and more.

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Smith+Nephew is an equal opportunity employer. We support diversity and inclusion in our workforce.

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