This is a permanent hybrid role with full Stryker benefits.
Who we want
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
What you will do:
As a Senior (Advanced) Quality Engineer, you will influence Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects. You will have the responsibility to drive reliability engineering, human factors engineering, risk management, and design validation, while ensuring compliance to Stryker quality system, FDA Quality System Regulations, ISO 13485 and other medical device regulations.
Develop quality assurance documentation to support new product development process and regulatory submissions.
You will guide new product development teams through internal quality system requirements to launch new products.
You will influence cross-functional project teams to build quality into product and/or process design and development activities.
Support quality system maintenance by identifying and correcting deficiencies in procedures and practices.
You will lead risk management for new development products, including risk analysis and development of sound mitigation strategies.
Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.
Engage in design reviews by identifying risks associated with the product used and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
Support design engineering and advanced operations team in problem solving.
Support Advanced Operations in the definition and development of manufacturing processes and process controls for new products.
You will use quality engineering tools, statistical methods, design development methods, process development and control methods, and design verification and validation planning to build quality into new products during development.
Develop, review, and approve inspection plans, routers, and product drawings for new products.
You will evaluate project tangibles for technical competence and compliance to ensure we are delivering robust products.
Analyze and define critical quality attributes for product and process through risk analysis techniques.
Support product design transfers to internal and/or external manufacturing facilities.
Evaluate predicate products for relevant quality issues that may impact new product development projects.
Participate in collection of initial market feedback on new products and address early concerns.
You will lead formative and summative studies with our customers and other human factors engineering activities to develop intuitive and safe new products.
You will lead design validation efforts to ensure new products meet all customer user needs.
You may lead NC & CAPA, which require expertise in problem solving and root cause analysis.
What you need:
Bachelors in a science, engineering or related discipline (Level 8).
A minimum of 2+ years of experience in a Technical Engineering or Quality Engineering position within an R&D or manufacturing environment.
Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.