Product Development Engineer

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION

Join our collaborative Research & Development team in Meriden, CT as an Engineer , where you will play an important role in supporting commercially released products while also contributing to product and process improvement activities that strengthen long-term manufacturing capability. In this role, you will help ensure products remain compliant, consistent, and aligned with evolving materials, processes, equipment, manufacturing locations, and regulatory requirements, while also supporting initiatives that improve product robustness, manufacturability, and technical performance. This position is ideal for an engineer who enjoys working in a regulated manufacturing environment and has a strong interest in understanding how product design, manufacturing processes, and technical changes interact. You will develop deep knowledge of the product, process, and plant operations in order to assess the impact of change, support product evolution, and help ensure products continue to meet customer, regulatory, and business requirements. In this role, you will lead and support technical activities such as material changes, supplier changes, equipment updates, process improvements, qualification activities, and regulatory-driven updates. You will partner closely with Manufacturing, Quality, Regulatory, Product Development, and other cross-functional teams to perform technical assessments, define testing strategies, and execute or support verification and validation activities needed to confirm that product performance and design intent are maintained. This role combines technical analysis, engineering judgment, documentation, and hands-on engagement with manufacturing and testing. You will author and maintain engineering assessments, technical justifications, protocols, reports, and change documentation, helping ensure that product and process changes are implemented in a controlled, compliant, and scientifically sound manner. In addition, the role offers the opportunity to contribute to broader product and process development efforts, supporting the ongoing evolution of manufacturing capability and technical knowledge within the organization. Your work will directly support Thermo Fisher Scientific's mission by helping ensure our products continue to perform reliably and safely for customers around the world.

REQUIREMENTS

Education and Experience Bachelor's degree in Engineering or a scientific discipline and 5+ years of relevant experience in product engineering, sustaining engineering, manufacturing engineering, product development, commercialization, applied research, or a related technical field; or Advanced degree and 3+ years of relevant experience; or High school diploma/GED and 10+ years of equivalent industry experience in a related technical role. Preferred Fields of Study Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, Manufacturing Engineering, or related scientific/engineering discipline. Required Experience Experience in a regulated industry such as medical device, biopharmaceutical, life sciences, or other highly controlled manufacturing environment. Experience supporting post-market or sustaining products, including evaluating and implementing changes to materials, processes, equipment, suppliers, manufacturing locations, or product design. Demonstrated ability to perform technical impact assessments and determine how proposed changes may affect product performance, compliance, and design intent. Experience authoring technical documentation such as engineering assessments, risk analyses, protocols, reports, investigations, and change qualification packages. Experience supporting verification, validation, and/or qualification testing to confirm product equivalency and compliance. Experience collaborating cross-functionally with Manufacturing, Quality, Regulatory, R D, Supplier Quality, and Operations teams. Proven ability to analyze technical problems methodically and make sound engineering decisions in a documentation-driven environment. Preferred Experience Familiarity with quality systems such as

ISO 9001, ISO

13485, GMP, or related standards. Experience working directly in a manufacturing plant environment and partnering closely with production teams. Experience with risk assessment tools such as FMEA and with change control/design control processes. Experience with statistical analysis and data interpretation to support engineering decisions. Experience with filtration, separation, membranes, single-use technologies, or related bioprocess/manufacturing products. Knowledge, Skills, and Abilities Strong understanding of how changes in materials, processes, equipment, suppliers, or manufacturing sites can impact product performance and regulatory compliance. Ability to learn and apply detailed knowledge of product design, manufacturing processes, and plant operations to assess change impact. Strong technical writing skills with the ability to create clear, traceable, and defensible engineering documentation. Solid understanding of verification/validation principles and the ability to define or coordinate testing to ensure product consistency. Strong organizational skills and attention to detail, with the ability to manage multiple change activities and documentation packages simultaneously. Effective verbal and written communication skills, with the ability to collaborate across local and global cross-functional teams. Proficiency with Microsoft Office and familiarity with engineering, quality, or document management systems. Strong analytical reasoning, problem-solving ability, and the ability to work independently while maintaining strong collaboration with others. Ability to work in a manufacturing environment and engage directly with product, process, and testing activities as needed.

Additional Information Location:

Meriden, CT May require up to 10% domestic/international travel. May require work in manufacturing, laboratory, or controlled environments with use of appropriate PPE. Requires 32 hours/week in office. Compensation and Benefits The salary range estimated for this position based in Connecticut is $91,700.00-$130,000.00. 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