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-teamWe 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.comStryker is seeking to hire a Principal Software Design Quality Engineer (Remote) supporting Stryker's Medical Division to lead software Digital Health projects on new product development projects!Who We Want:
Self-directed initiators . People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Quality-oriented developers . Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions. Design capable Engineers who have the vision to push product designs to their limits to build design quality understanding and improvement.
Collaborative partners . People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
What you will do:
Lead quality assurance for new product development for the global Digital Health Portfolio for the Acute Care business at the Medical Division of Stryker.
Collaboratively drive software design, development, verification and validation strategies while aligning with the compliance requirements in the Quality Management Systems.
Collaborate with cross functional stakeholders including marketing, R&D, clinical, regulatory, operations and other core functions to deliver quality products.
Lead risk management activities leveraging ISO14971 standards to ensure safe medical products. Analyze and define critical quality attributes for products. Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.
Engage in Voice of Customer events to define user needs, usability, market feedback to support DIOVV activities.
Lead Quality Management System process definition and updates for software lifecycles applying software industry practices, compliance standards and guidance (FDA/TGA/EUMDR).
Engage in interdivisional, cross-functional project teams to lead product and/or process design and development activities for medical and non-medical software (SaMD, MDDS, AI/ML).
Utilize standard software development practices to drive adoption of processes and methodologies like SAFe for mobile development, cloud solutions and applications.
Ensure cybersecurity, data privacy and interoperability of the digital products are designed in.
Review software artifacts and drive design review of systems to ensure compliance and traceability.
Mentor other Quality Engineers.
What you need:Required :
Bachelor's Degree Required. Preference for Computer Engineering, Software Engineering or related.
8+ years of work experience.
Experience in the medical device industry.
Preferred :
Experience with medical device product development lifecycle, including risk management and design/process verification and validation.
Demonstrated applied knowledge of software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and Risk assessments.
Demonstrated experience working with software development R&D teams leveraging processes such as SAFe or Agile.
Knowledge of software design and development, release management, defect management and testing tools and processes. (Bitbucket/Github/Jira/Confluence).
Knowledge of software technologies for mobile, cloud and AI/ML solutions. (Amazon AWS/Microsoft Azure/Apple/Android etc.)
Thorough knowledge and understanding of US and International Medical Device Regulations (820/IEC 62304/IEC82304)
Demonstrated experience participating in both internal and external audits.
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).
Highly developed problem-solving skills. Strong analytical skills.
Demonstrated ability to successfully manage and complete projects in a matrix organization.
$112,800-$239,000salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.About StrykerOur 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 (https://cdn-static.findly.com/wp-content/uploads/sites/1427/2023/09/20143933/us-stryker-employee-benefits.pdf)About StrykerStryker 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. (http:)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 on our referral page (https://careers.stryker.com/referrals/)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 Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
