Principal Design Quality Engineer - WATCHMAN
About The Position
In-depth understanding and application of Design Control and Risk Management concepts. Provide quality and compliance input to project teams. Support the execution and documentation of Design Validation & Verification and Usability activities. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization. Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications). Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs). Lead and support cross-functional root-cause analysis investigation and resolution activities Support regulatory submissions to notified bodies. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Requirements
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related Engineering field of study
- Minimum of 8 years of experience in design assurance, quality, or related medical device or regulated industry experience
- Experience in new product development: e.g. driving and creating risk management deliverables (risk management plan/report, hazard analysis, task analysis, dfmea, etc.), validating test methods, supporting the creation of design requirements, design verification and validation
- ISO 13485, ISO 14971, CFRs, and Quality System Regulations understanding & demonstrated use
- Excellent organizational and planning skills; drives for results
- Strong communication skills (verbal & written)
- Demonstrated use of Quality tools/methodologies
- Ability to travel up to 10%
- Experience in developing test methods
- Problem solver, capable of facilitating the problem-solving process
- Adaptable and effective collaborator in a team environment and in self-directed work
- Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups.
- Experience with Class III Medical Devices
Responsibilities
- Provide quality and compliance input to project teams.
- Support the execution and documentation of Design Validation & Verification and Usability activities.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
- Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications).
- Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
- Lead and support cross-functional root-cause analysis investigation and resolution activities
- Support regulatory submissions to notified bodies.
- Maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
