Principal Design Quality Engineer position to work on the Axonics Integration project, ensuring product and process safety, quality, and compliance with BSC and regulatory requirements.
Requirements
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Act as an effective team member in supporting quality disciplines, decisions, and practices
- Work within a cross-functional team to identify and implement effective controls and support integration of design control related products, records, and processes
- Write various technical documentation for procedure execution, technical rationale, and evidence of the development process.
- Support Design Assurance activities as related to Risk Management remediation, Design Control Quality System integration, and other DA related integration priorities
- Support Post Market activities, as necessary, of risk based on post-market signals
- Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed
- Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards.
- Support the verification, validation, and usability testing to meet or exceed internal and external requirements
- Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
- Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)
- Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
- Partner cross-functionally to identify and support value improvement efforts to support business goals
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- 401k plan
- Retirement plan
- Paid time off
- Relocation assistance
