Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions. Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.
What you will do
As a Staff Engineer, Design Assurance, you will partner with Product Development and Advanced Operations to define design requirements and develop manufacturing processes, respectively, for orthopedic surgical robotics product launches. Also lead risk-management activities in the new product development process to ensure the highest level of product and process quality.
Partner with cross functional project teams to lead product and/or process design and development activities
Lead Risk Management activities for high-volume orthopedic product launches
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 how the design, documentation and manufacturing process mitigate risks linked to product
Partner with Product Development to define design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria
Partner with Advanced Operations in the development of manufacturing processes for new products
Develop, review and approve inspection plans, routers and product drawings
Partner with Advanced Operations to define process and process controls and subsequently design transfer product to manufacturing
Develop quality assurance documentation to support regulatory submissions
Work with complaint investigators to complete post-market health risk assessments
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)
What you need
Bachelor’s Degree in Engineering.
Minimum 5 years working in quality, engineering or new product development environment.
Bachelors Degree or Master’s degree in relevant field desired.
Medical Device or highly regulated industry experience desired.
Employer will assist with relocation costs.
Internal Number: R411529
Stryker is a global leader in medical technology with a history of success and exceptional growth. We offer results-driven people a place where they can make a difference. It is our privilege to create medical technology that exceeds our customers’ expectations and improves peoples’ lives around the world.