Job Information
Thermo Fisher Scientific, Inc. Sr. Design Compliance Quality Engineer in Grand Island, New York
Thermo Fisher Scientific Inc. seeks a Sr. Design Compliance Engineer in Grand Island, NY to:* Provide guidance for product development under Design Controls: User and Product requirements, Functional Specifications, Design Verification, Test Method Validation, Risk Management, and Design Reviews.* Provide guidance on Design Control Standards and Regulations including IVD requirements and various product types such as Reagents, Instrument and Software.* Provide guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.* Collaborate with New Production Introduction teams to meet compliance requirements on schedule.* Support New Product Introduction (NPI) programs by providing input to the development teams and authoring or approving New Design Controls deliverables.* Provide guidance and coaching for post market product sustaining activities, such as design changes and CAPAs.Travel: Up to 5% domestic and international travel required. MINIMUM REQUIREMENTS: Bachelor's degree or foreign degree equivalent in Materials Science and Engineering, Manufacturing Engineering, or related field of study plus 3 years of experience as a Design Compliance Engineer, Quality Engineer, or related occupation. Employer will also accept a Master's degree or foreign degree equivalent in Materials Science and Engineering, Manufacturing Engineering, or related field of study plus 1 year of experience as a Design Compliance Engineer, Manufacturing Engineer, or related occupation as an equivalent alternative. Required knowledge or experience with:* Design Controls, Risk Management, and regulatory guidelines and their application;* Implementing Design for Compliance and training programs;* Product Commercialization Process;* ISO 9001 and ISO 13485;* Validation and verification processes;* Root cause analysis and implementing corrective actions;* Technical writing skills for creating and maintaining control documentation;* Failure Modes and Effects Analysis (FMEA).
Minimum Salary: 118206 Maximum Salary: 128000 Salary Unit: Yearly