Product Development Engineer

Thermo Fisher Scientific•Charlotte, NC

12d•Onsite

About The Position

Join Thermo Fisher Scientific’s Research & Development team in Charlotte, North Carolina, supporting commercially released products and contributing to product and process improvements that strengthen long-term manufacturing capability. The role helps ensure products remain compliant, consistent, and aligned with changes to materials, processes, equipment, suppliers, manufacturing locations, and regulatory requirements. It also supports improvements to product robustness, manufacturability, and technical performance in a regulated manufacturing environment. The engineer develops detailed knowledge of product design, manufacturing processes, and plant operations to assess proposed changes and support product evolution. The role leads or supports technical activities including material and supplier changes, equipment updates, process improvements, qualification activities, and regulatory-driven updates. Working with Manufacturing, Quality, Regulatory, Product Development, and other cross-functional teams, the engineer performs technical assessments, defines testing strategies, and executes or supports verification and validation activities. The position combines technical analysis and engineering judgment with documentation and hands-on engagement in manufacturing and testing. The engineer authors and maintains assessments, technical justifications, protocols, reports, and change documentation to support controlled, compliant, and scientifically sound implementation of product and process changes. The role may also contribute to broader product and process development efforts. The position is based in Charlotte, NC. Relocation assistance is not provided. Candidates must be legally authorized to work in the United States without sponsorship and must be able to pass a comprehensive background check, including drug screening. The work schedule is standard Monday through Friday. The work environment includes a laboratory and office setting, manufacturing equipment noise, GMP safety standards, and some required PPE. The role requires being able to lift 40 pounds without assistance.

Requirements

Bachelor’s degree in Engineering or a scientific discipline and 5+ years of relevant experience; or an advanced degree and 3+ years of relevant experience; or a high school diploma/GED and 10+ years of equivalent industry experience in a related technical role.
Relevant experience in product engineering, sustaining engineering, manufacturing engineering, product development, commercialization, applied research, or a related technical field.
Experience in industrial sectors such as microelectronics, food and beverage, or another 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.
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.
Ability to analyze technical problems methodically and make sound engineering decisions in a documentation-driven environment.
Strong understanding of how changes in materials, processes, equipment, suppliers, or manufacturing sites can affect 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 and ability to create clear, traceable, and defensible engineering documentation.
Understanding of verification and validation principles and ability to define or coordinate testing to ensure product consistency.
Strong organizational skills and attention to detail, including ability to manage multiple change activities and documentation packages simultaneously.
Effective verbal and written communication skills and ability to collaborate across local and global cross-functional teams.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, including a drug screening.
Able to lift 40 pounds without assistance.

Nice To Haves

Preferred fields of study include Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, Manufacturing Engineering, or a related scientific or engineering discipline.
Experience in a regulated industry such as medical device, biopharmaceutical, life sciences, or another 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.
Knowledge of filtration, separation, membranes, single-use technologies, or related bioprocess/manufacturing products.

Responsibilities

Support commercially released products and product and process improvement activities.
Assess the impact of changes to materials, suppliers, equipment, processes, manufacturing locations, product design, and regulatory requirements.
Lead or support material changes, supplier changes, equipment updates, process improvements, qualification activities, and regulatory-driven updates.
Partner with Manufacturing, Quality, Regulatory, Product Development, and other cross-functional teams on technical assessments and change activities.
Define testing strategies and execute or support verification, validation, and qualification activities to confirm product performance, equivalency, and design intent.
Author and maintain engineering assessments, technical justifications, risk analyses, protocols, reports, investigations, and change documentation.
Help ensure product and process changes are implemented in a controlled, compliant, and scientifically sound manner.
Contribute to product and process development and the evolution of manufacturing capability and technical knowledge.