Job Details
At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.
Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team
We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com
Stryker is hiring a Staff Advanced Quality Engineer (Hybrid) to support the Stryker Spine division in Shirley, Massachusetts to work as development partner with the product design & development teams and evaluate new products & existing product modifications to the applicable requirements of Design and Change controls. This Engineer will lead and own risk management activities to ensure the highest level of product and process quality.
Workplace Flexibility (Hybrid): Candidate must reside within a commutable
distance to Shirley, Massachusetts as you will be expected to be onsite at the facility multiple times/week.
Who we want-
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.
What you will do:
- Perform risk analysis and develop mitigation strategies, ensuring alignment with ISO 14971.
- Collaborate with R&D, AQEs, and SQEs on risk management activities, including the Software Design Life Cycle (IEC 62304).
- Guide Product Engineering through internal quality systems to ensure compliance with FDA, ISO, and other regulatory bodies.
- Develop, modify, and execute regulatory-related company guidelines and procedures.
- Review and evaluate project documentation for regulatory compliance and technical soundness.
- Author technical assessments and participate in Health Hazard Evaluations, including discussions with medical professionals and regulatory agencies.
- Support process validation programs for new and existing product development.
- Develop and update procedures for incoming, in-process, and final inspections.
- Provide quality perspective input throughout the design change process.
- Collaborate with Design Engineers to develop robust verification test strategies.
- Analyze failures using root cause analysis techniques.
- Perform supplier development activities, including PPAP.
- Conduct internal quality system audits and manage CAPA projects.
- Educate Product Engineering on risk management tools, statistical methods, design and process control activities, and verification and validation test planning.
- Train others on QA topics.
- Coordinate and present Health Hazard Evaluations to the Risk Management Board and Corporate.
- Participate in discussions with regulatory agencies regarding potential Product Field Actions.
What you will need
Required:
Bachelor’s degree in science or an Engineering discipline required.
Over 5 years of engineering experience in the medical device industry, with foundational knowledge of FDA regulations, ISO 14971, and other relevant standards. Possesses strong expertise in quality concepts, including CAPA, audits, and statistics.
Preferred:
MS, CQE, or CRE preferred. Six Sigma Green or Black belt preferred
Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
Demonstrated ability to read and interpret CAD drawings.
Experience with software development life cycle (SDLC), preferably compliant with IEC 62304, IEC is a plus.
Working knowledge of effective implementation of all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process
Our benefits:
-
12 paid holidays annually
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.
For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.
Know someone at Stryker?
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Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers... Read more