Senior Design Compliance Quality Engineer

Job Title Senior Design Compliance EngineerWhen you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.How will you make an impact?Here is your opportunity to link your work experience with a job that allows you to be involved on projects developing real new world solutions. Your unique skillset is needed. If you have a Quality background in NPI (new product introduction) in IVD or Medical Devices, you are needed. If you have a statistics background, you are sought. If you have ASQ certifications, you certainly are in high consideration. And if you have experience with Software, you would be highly valued.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. This Design Assurance position is also responsible for providing guidance and coaching for post market product sustaining activities, such as design changes and CAPAs.How will you get here?Bachelor's degree in a Technical or Engineering discipline required

Experience in instrumentation and software product development is a plus.

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.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.