Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

COMPANY:                            Thermo Fisher Scientific, Inc.

LOCATION:                            3175 Staley Rd., Grand Island, NY 14072

TITLE:                                    Sr. Design Compliance Quality Engineer

HOURS:                                  Monday to Friday, 8:00 am to 5:00 pm

DUTIES:                                 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 decision 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.

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, Quality 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).

Salary: $118,206 to $128,000 per year.

#LI-DNI

87212267.v1-IMMIGRATION

Compensation and Benefits

The salary pay range estimated for this position Engineer III, QA based inNew York is $118,206.00–$128,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards