Who we want 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 Senior Engineer, Design Assurance, you will lead Quality Engineering activities in the development of robotically-assisted surgical systems to ensure the highest level of product and process quality. Also provide guidance to the New Product Development teams to ensure compliance to the company’s quality system and external standards.
Support design, development and manufacturing of robotic systems, software and instruments.
Develops Quality Assurance Plans for new products.
Lead risk management activities for robotics by developing risk management plans/reports, conducting risk reviews, verifying implementation and effectiveness of risk controls and driving post market activities.
Partner with engineering to define design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria. Promote efficient testing practices.
Complete or contribute to the completion of final design verification and design validation test reports by providing clear concise conclusions with statistical validity and graphical support when necessary.
Utilize standard statistical analysis and problem-solving techniques as necessary to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
Identify supplier assessment requirements and communicate these to the supplier quality group.
Evaluate product design changes for verification and validation requirements and assist in change implementation.
What you need
Bachelors Degree in Engineering
Minimum 2 years’ experience in working in a highly regulated environment, quality, manufacturing, new product development or engineering.
Prefer CQE certification and Six Sigma Green or Black Belt
Prefer experience with medical device product development life cycle, including risk management and design/ process verification & validation
Knowledge of FDA QSRs, ISO 13485 Design Control Procedures and ISO 14971
Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poka Yoke.
Demonstrated ability to read and interpret CAD drawings
Demonstrated ability to advocate product excellence and quality
Demonstrated ability to effectively work cross functionally with other departments including Advanced Operations, Product Development, Regulatory and Marketing.
Demonstrated problem-solving and troubleshooting skills.
Demonstrated interpersonal and communication skills.
Demonstrated a positive, energetic approach to teamwork.
Demonstrated ability to learn quickly and multi-task
Employer will assist with relocation costs.
Internal Number: R422709
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.