Sr. Design Compliance Quality Engineer

What will you do?

• Provide guidance for product development under Design Controls: User and Product requirements, Functional Specifications, Design Verification, Design Validation, Test Method Validation, Risk Management, and Design Reviews.
• Provide guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards
• Work closely with New Product Introduction teams to meet compliance requirements on schedule
• Participate on team projects and assignments, facilitating or leading sub-teams as necessary.

• The Senior Design Compliance Engineer will be responsible for supporting New Product Introduction (NPI) programs by providing input to the development teams and authoring or approving Design Controls deliverables.

How will you get here?

Education

Bachelor’s degree in a Technical or Science discipline required.

Experience

• Experience implementing Design for Compliance and training programs
• Experience in the Lab / IVD / Medical Device field is preferred.
• Four (or more) years of progressive professional experience in Design Compliance or Quality Engineering role.
• Knowledge, Skills, Abilities
• Strong knowledge of Design Controls, Risk Management, and regulatory guidelines and their application
• Excellent interpersonal and communication skills with ability to effectively interface with technical personnel at various levels of the organization.
• Ability to act quickly and decisively