Product Development Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, 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.

Location: Charlotte, NC. Relocation assistance is NOT provided.

• Must be legally authorized to work in the United States without sponsorship.

• Must be able to pass a comprehensive background check, which includes a drug screening.

DESCRIPTION:

Join our collaborative Research & Development team in Charlotte, NC 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 industrial sectors such as microelectronics, food & beverage, 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, Marketing, and Operations teams.

• Proven ability to analyze technical problems methodically and make sound engineering decisions in a documentation-driven environment.

Preferred Experience

• Experience in a regulated industry such as medical device, biopharmaceutical, life sciences, or other highly controlled manufacturing environment.

• 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.

Apply today! http://jobs.thermofisher.com

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company 401k, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.