Design Assurance Engineer
Direct hire, east side location, 90 - 100K
Reporting to the Sr. Manager, Quality, the Senior Product Quality Engineer will be responsible for supporting New Product Development (NPD) design assurance by providing input to the development teams, authoring or approving Design Control deliverables such as Risk Management Files, Quality Plans, and Design Verification and Validation Plans. This position is also responsible for providing guidance and coaching for post market product sustaining activities, such as design changes and CAPA.
- Provide guidance on New Product Development projects for: User Need Specification, Design Specification, Design Verification, Design Validation, Test Method Validation, Risk Management File, Design Transfer and Design Reviews.
- Facilitate risk management activities for new products using Risk Assessment Documents and FMEAs, as applicable.
- Review and approve product specification documentation for new products.
- Define work breakdown structures and quality plans for New Product Development as required.
- Ensure the Design History File for new products is adequately maintained and complete prior to product launch.
- Ensure design changes are captured and follow the design change control process.
- Identify the opportunities for continuous improvement of the Quality Systems, including the design control, risk management, document generation, and design testing processes.
- Participate on team projects and assignments, facilitating or leading teams as necessary.
- Provide guidance to test method development/validation, sample plan definition, and design validation development.
- Provide guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.
- Provide coaching to teams on post market product design change projects and CAPA.
- Use of risk management tools to evaluate impact of change.
- Ensure product verification and validation requirements are reviewed and defined appropriately.
- Represents Quality on Business Teams.
- Customer Advocate - provide a direct link between customer and process quality, manufacturing, and engineering in Rochester.
- Bachelor’s of Science Degree in Engineering or equivalent experience, and a minimum of 3 years direct Quality Engineering experience with expertise in Design Control for medical device industries.
- Experience in regulated medical device manufacture with compliance to FDA Quality System Regulation, EU Medical Device Directive and ISO 13485.
- Working knowledge of EN ISO 14971:2012.
- Working knowledge of Excel, Word, Access, quality software, and statistical methods (Statistical Process Control, Design Of Experiment, Gauge R&R, etc.).
- Familiarity with test methods, sampling plans and standards for the design, verification, and validation of medical device products, including sterilization, biocompatibility, packaging validation is a plus.
Additional Skills & Abilities
- Project planning and advanced computer skills.
- Plastic product manufacturing experience.
- Experience in New Product Development from product realization to product launch as a technical function.
- Experience in Process Validation (IQ/OQ/PQ).
- Demonstrated change agent for Quality Systems - that includes ability to challenge the status quo & affecting change to achieve business results.
- ASQ certification or Lean Six Sigma certification.