Stryker (United States)

Weston, FL

Senior Engineer - Software Design Assurance

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. 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


Who we want

  • Patient-oriented achievers. Engineers with an unparalleled work ethic and customer-focused attitude who bring value to their partnerships.
  • Charismatic networkers. Relationship-savvy people who intentionally make connections with both internal partners and external contacts.
  • Challengers & Influencers. People who constantly challenge themselves and each other to achieve more & to win the right way.
  • Teammates. Partners who listen to ideas, share thoughts and work together to move the business forward.

What you will do

As a Senior Engineer, Software Design Assurance you will develop and implement methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Analyze reports and defective products to determine trends and recommend corrective actions. Collaborate with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.

Responsibilities:

  • Partner with cross functional project teams to lead product and/or process planning, design and development activities
  • Partner with Product Development to define requirements that will ensure appropriate level of rigor to software validation
  • 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
  • Provide guidance to the development team through Software Development and New Product Development process including demonstrating understanding of software lifecycle methodologies (e.g. Waterfall, Agile).
  • 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 actions/preventive actions (CAPA)
  • Participate in internal and external compliance audits

What you will need

  • Bachelors Degree & equivalent work experience in a software related role
  • 2+ years experience working in a highly regulated environment, software related role, engineering, quality, manufacturing or new product development.

Preferred Qualifications:

  • Bachelor’s Degree in Computer Science or related field of study strongly preferred
  • Prefer CQE certification or equivalent and Six Sigma Green or Black Belt
  • Experience as a Quality Engineer (QE) in a regulated design environment
  • Knowledge of medical device product development life cycle, including risk management and design/ process verification & validation and computer software validation.
  • Knowledge of FDA QSRs, ISO 13485 Design Control Procedures, IEC 62304 and ISO 14971

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program.