Senior Design Quality Engineer (Hybrid)
Stryker is hiring a Senior Design Quality Engineer (Hybrid), area to join our Communications Quality Assurance team! We are looking for a hands-on engineer passionate about innovation, being part of new product development, and ensuring product quality. In this role, you will focus on new product development for our surgical light, surgical table, and boom portfolios.
Experience the future of the OR: Stryker Communications
We are passionate about driving innovation and working with our customers to improve healthcare through high-quality product releases! This role will have the opportunity to engage with customers in the operating room (OR) setting to understand customer needs and challenges so that they can effectively drive patient safety and surgical workflow efficiency solutions to our customers through new product releases.
Work Flexibility: Hybrid. This role requires reasonable proximity to our Stryker facility. You should be comfortable working 3-4 days onsite.
Who we want:
Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to design medical devices.
User-focused creators. Engineers who design with the user in mind, developing medical devices that help change patients’ lives.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
What you will do:
Cybersecurity Risk Assessment: Identify and analyze potential cybersecurity risks to offer design recommendations to minimize cybersecurity risks. Collaborate closely with SW Systems and Development Engineers leverage software architecture.
Partner with R&D and other cross-functional teams to define design requirements and develop manufacturing processes to support new product development projects.
Lead risk management activities for new product development projects and to ensure the highest level of product quality.
Partner with cross-functional project teams to lead product and/or user design and validation development activities.
Develop quality engineering documentation to support new product development processes and regulatory submissions.
Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.
Present risks associated with the product use during Design Reviews and track the design, documentation, and manufacturing process mitigate those issues throughout the development process.
Partner with cross-functional project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
Develop, review, and approve inspection plans, routers, and product drawings for new products.
Support product design transfers to internal and/or external manufacturing facilities.
Provide support and direction for other Quality Engineers.
Evaluate predicate products for relevant quality issues that may impact new product development projects.
Analyze and define critical quality attributes for product and process through risk analysis techniques.
Participate in collection of initial market feedback on new products and address early concerns.
Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
What you need:
Required:
Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or Software Engineering or a related engineering discipline. Mechanical Engineering strongly preferred.
Minimum of 2+ years of experience within a regulated industry – Medical Device or Pharmaceutical is strongly preferred.
Preferred:
Proven work experience in software quality assurance preferred.
Previous experience working with OEMs to launch new medical devices, highly desired.
Technical experience should include but not limited to: New Product Development, Product Quality, Risk Assessment, Risk Management, Design Assurance, Design Verification and Validation, Defect Reviews, Product Reliability and Durability.
Ability to influence and lead others without direct authority.
Demonstrated ability to effectively work cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
Demonstrated ability to advocate for product excellence and quality.
Preferred experience with medical device product development lifecycle, including risk management and design/process verification and validation.
Thorough knowledge and understanding of US and International Medical Device Regulations preferred.
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.)
Experience in working in a compliance risk situation.
Strong knowledge of Quality Concepts
Must possess strong project management skills as well the ability to manage multiple tasks simultaneously.
Strong in critical thinking and "outside the box" thinking along with highly developed problem-solving and analytical skills.
