Design Quality Engineer III - Bolt Integration
About The Position
The Design Quality Engineer III provides support with high visibility which will provide the right candidate with excellent growth potential. Work with high-performance cross-functional sustaining team to ensure safety, quality and compliance of launched products while continuously improving their commercial value through end-of-life. The role would be supporting SEISMIQ console sustainment manufactured at Arden Hills and Carlsbad site. The Design Quality Engineer III works in close partnership with Research and Development and supporting functions (supplier engineering, operations, regulatory, post market) focuses on protecting the design intent of a product to meet safety, efficacy, regulatory, and business requirements.
Requirements
- Bachelor’s degree in chemical, medical engineering, science, mechanical, electrical, computer engineering, or related discipline
- 3+ years experience in design assurance, new product development, or related medical device / regulated industry experience
- Working knowledge of US and International regulations including 21 CFR 820, Medical Device Directive / Medical Device Regulation, EN ISO 13485, and EN ISO 14971
- Strong communication skills (verbal & written)
- Demonstrated use of Quality tools/methodologies.
- Ability to effectively work and collaborate in a cross-site environment.
Nice To Haves
- Experience with medical electrical systems / electrical medical equipment / capital equipment and software (inclusive of IEC 62304)
- Previous development of medical device system experience
- Problem solver, capable of facilitating the problem-solving process
- Adaptable and effective collaborator in a team environment or in self-directed work
- Experience with design changes, complaint risks, and corrective action
- Acquisition experience with cross-site collaboration
Responsibilities
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Proactively investigates, identifies, and implements best-in-class Design Quality Engineering practices.
- Actively participate in the Design Change process for systems to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed through the Design Control process.
- Partner with R&D, manufacturing, supplier team and cross-site teams to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
- Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, which may include NCEP and CAPA ownership, core team member and coordination
- Monitor field performance of recently launched and established medical devices against risk assessments
- Actively participate on Risk Change assessment process: generate, update, and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
- Support the verification, validation, and usability testing to meet or exceed internal and external requirements
- Interact with software changes for alignment with system level design impact assessments.
- Develop, update, and maintain Design History File and work with RD for Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
Benefits
- Relocation assistance may be available for this position at this time.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
