Design Quality Engineer (Andover, MA)

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

Job summary

A leading company in medical technology is seeking a Design Quality Engineer in Andover, MA. This role supports New Product Development activities, focusing on risk management and quality assurance for hardware and software products. The ideal candidate will have a background in engineering and experience in the medical device industry, contributing to cross-functional teams and ensuring compliance with quality standards.

Benefits

401k matching

Health insurance

Work/life balance initiatives

Training

Extra perks

Qualifications

• 2-5 years' quality engineering experience in medical devices or a regulated industry.
• Knowledge of ISO 14971, IEC 62304, ISO 13485 preferred.

Responsibilities

• Support development and implementation of risk management files for new products.
• Participate in cross-functional teams to support product development.
• Assist in design verification, validation, and usability testing.

Skills

Time Management

Collaboration

Communication

Accountability

Education

Bachelor's degree in engineering or a related field

Job description

Join to apply for the Design Quality Engineer (Andover, MA) role at Smith+Nephew

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 supports New Product Development (NPD) activities for Hardware/Software products in the Sports Medicine franchise. The role involves collaborating with project teams to develop project plans, manage activities related to new product development, and support design control and risk management activities in line with internal procedures and standards.

Key Responsibilities

1. Support development and implementation of risk management files for new hardware/software products, including FMEA, risk control, and verification of effectiveness.
2. Participate in cross-functional teams to support hardware/software product development, contributing to user needs, design inputs, software requirements, and design outputs.
3. Assist in design verification, validation, and usability testing, including protocol and use case development, testing, and reporting.
4. Develop and release engineering documentation, support design reviews, and maintain design history files.
5. Support manufacturing quality activities such as measurement systems analysis, incoming inspection, control plans, and FMEA.
6. Assist with regulatory submissions and support audits and inspections.
7. Enhance knowledge of design controls, risk management, testing, and applicable quality standards.

Qualifications

• Bachelor's degree in engineering or a related field.
• 2-5 years' quality engineering experience in medical devices or a regulated industry.
• Knowledge of ISO 14971, IEC 62304, ISO 13485 preferred.
• Strong time management, collaboration, communication, and accountability skills.

Additional Information

This position does NOT offer visa sponsorship now or in the future.

Travel requirements are flexible and aligned with business needs.

Why Join Us?

We invest in our people and the patients we serve, promoting diversity and inclusion. Benefits include 401k matching, health insurance, work/life balance initiatives, training, and extra perks.

Smith+Nephew is an equal opportunity employer. Join our talent community to stay updated on jobs and company news.