Job ID :
US - California - South San Francisco
- Provides guidance for: Market Specification, Functional Specification, Design Verification, Design Validation, Test Method Validation, Failure Mode Effects Analyses, and Design Reviews.
- Identifies the opportunities for continuous improvement of the Design Control process within the Quality System, design document generation, and design testing processes.
- Participates on team projects and assignments, facilitating or leading teams as necessary to support NPIs.
- Provides guidance to test methods, equipment acquisition, sample plan definition, and validation development.
- Provides guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.
- Provides direction and guidance to other Design Compliance engineers within Design Compliance team as needed.
REQUIREMENTS / EDUCATION:
- Demonstrated experience on Design Control for IVD or Medical device industries (CE IVD, FDA IVD, etc).
- Demonstrated change agent for Quality Systems - that includes ability to challenge the status quo & effecting change to achieve business results.
- Demonstrated ability to manage & implement multiple, large scale projects with minimal supervision, across the business &/or at remote &/or global locations.
- Requires the ability to perform independently & as part of a team.
- Must be able to influence & negotiate with people & resolve issues.
- Ability to make rational, objective & appropriate decisions relating to company & department needs & resource allocation.
- Ability to identify customer needs, issues and develop realistic solutions to meet needs & solve problems.
- Ability to communicate recommendation and decisions across a wide spectrum of the organization.
- Bachelor degree (or higher) in a Technical Field.
- 6 years in a Design Compliance quality engineering role in regulated industry (IVD or Medical Device).
- In depth knowledge of Quality Systems, IVD/medical device/Pharma manufacturing and regulatory requirements over a number of years.
- Excellent communication and presentation skills