Senior Design Quality Engineer - Urology
About The Position
Your responsibilities will include: 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. Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling). Support regulatory submissions to notified bodies.
Requirements
- Bachelor's degree in chemical engineering, Biomedical Engineering, or related engineering field
- 5+ years of experience in design assurance, quality, new product development, or sustaining related medical device / regulated industry experience
- Detailed understanding of US and International regulations including 21 CFR 820 is required, as well as the Medical Device Directive, EN ISO 13485, and EN ISO 14971.
- Independently leads quality deliverables and supports decision-making with little supervision
- Adaptable and effective collaborator in a team environment and in self-directed work
- Strong communication skills (verbal & written)
- Demonstrated use of Quality tools/methodologies
Nice To Haves
- Experience with pharma/combination devices with working understanding of US regulations including 21 CFR, 210, 211, and 11 is preferred.
Responsibilities
- 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.
- Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
- Support regulatory submissions to notified bodies.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
