Senior Engineer- Software Quality

Why engineering at Stryker?

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

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• Minimum 6-8 years of experience as a Software Quality Engineer (Software QE) in a regulated design environment. Prefer experience with medical device product development life cycle, including risk management and design/ process verification & validation

• Knowledge of FDA QSRs, ISO 13485 Design Control Procedures, IEC 62304 and ISO 14971, ISO 62366
• Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA) and Root Cause Analysis
• Demonstrated ability in Software Development Life Cycle (SDLC)
• Partner with cross functional project teams to lead product and/or process planning, design and development activities
• Lead Risk Management activities throughout the product development life cycle
• Partner with Product Development to perform risk evaluation of product design and to define design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria
• Develop quality assurance documentation to support regulatory submissions
• Lead quality system maintenance for the division by identifying and correcting deficiencies in our procedures and practices
• Manage, lead and/or assist in resolving nonconformities and corrective/preventive actions (CAPA)
• Participate in internal and external compliance audits
• Demonstrated ability to advocate product excellence and quality

• Demonstrated ability to effectively work cross functionally with other departments including Advanced Operations, Product Development, Regulatory and Marketing.
• Demonstrated problem-solving and troubleshooting skills.
• Demonstrated interpersonal and communication skills.
• Demonstrated a positive, energetic approach to teamwork.
• Demonstrated ability to learn quickly and multi-task
• Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
• Computer proficiency with, MS Office applications.