Philips is looking to ensure new products transition seamlessly to production, adhering to quality and regulatory standards by hiring a Design Quality Engineer.
Requirements
- Minimum 2+ years experience in Design Quality Management in Medical Device.
- Prefer 5+ years of experience with Design, Test Validation, Usability, Reliability, Performance, Manufacturability, Safety, Audit, CAPA.
Responsibilities
- Creates and executes comprehensive Design Test Method Validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision.
- Handles the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards.
- Keeps a check on the drafting and updating of detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements.
- Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
- Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.
Other
- Bachelor's Degree/ Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remoteposition.
- For our office-based teams, this means working in-person at least 3 days per week.
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
- Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Colorado Springs CO.
