Work ScheduleStandard (Mon-Fri)
Environmental ConditionsLaboratory Setting
Job DescriptionJob DescriptionThis role is based in the United States within our dynamic and innovative Engineering division. Join a team that thrives on collaboration, technical excellence, and a strong commitment to quality.
Discover Impactful Work
As a Product Engineer at Thermo Fisher Scientific, you will support the lifecycle of our Biopharmaceutical Filtration and Separation products by ensuring they remain compliant, consistent, and aligned throughout regulation, material, and manufacturing changes. This role is ideal for someone who enjoys methodically analyzing a variety of technical changes as well as documentation in regulated environments, while collaborating in a cross-functional global team.
A Day in the Life Lead and coordinate product and process change management projects, including raw material changes, quality improvements, supplier transitions, cost reductions, and regulatory-driven updates impacting one or multiple manufacturing sites.
Author, maintain, and organize comprehensive product documentation including engineering assessments, technical reports, justification documents, protocols, and change qualification packages.
Partner closely with global manufacturing sites to implement and validate changes.
Collaborate with interdisciplinary teams in the U.S. and internationally to maintain global product consistency.
Prepare and communicate documentation and results in both electronic and written formats.
Ensure strict adherence to quality and regulatory requirements (ISO 9001 with key elements of ISO 13485).
Drive continuous improvement using methodologies such as project management, Agile/SCRUM, Six Sigma, DOE, and Process & Product Understanding (PPU).
Keys to SuccessSuccess in this role requires exceptional organization, strong engineering fundamentals, and the ability to independently manage documentation-heavy work while collaborating effectively across
functions. This position is ideal for someone who wants a mix of technical analysis, methodical documentation, cross-functional communication, and periodic hands-on lab work.
Education High school diploma and 10+ years of equivalent industry experience, or
Bachelor's degree or higher in engineering or a scientific discipline with 5+ years of relevant engineering experience in product engineering, new product development, applied research, commercialization, or manufacturing engineering.
Experience (Required)
5+years in a regulated industry (medical devices, biopharma, life sciences strongly preferred).
Experience supporting or executing product change management, including impact assessments for material, process, or design changes.
Demonstrated success in roles requiring substantial technical documentation, including writing engineering justifications, assessments, risk analyses, protocols, investigations and reports.
Exposure to verification, validation, and qualification testing (design verification, validation and process qualification IQ/OQ/PQ).
Experience collaborating with Quality, Regulatory, Manufacturing, and/or Supplier Quality functions.
Ability to interpret engineering drawings, specifications, and product performance requirements.
Proven track record of analytical problem-solving and methodical technical decision-making.
Preferred Experience
Prior work within ISO 13485, ISO 9001, or similar quality systems.
Experience with filtration, membranes, or related bioprocessing technologies.
Experience in a role where documentation represented the majority of day-to-day responsibilities.
Knowledge, Skills & Abilities Strong understanding of product lifecycle management within regulated environments, including how changes affect product performance and end-user safety.
Ability to methodically analyze and document technical impact assessments for product or process changes.
High proficiency writing clear, traceable, and defensible engineering documentation.
Familiarity with Design Controls and risk assessment tools (e.g. FMEA)
Solid understanding of verification/validation methods and the ability to design or coordinate tests to confirm product equivalency.
Exceptional attention to detail and ability to manage large volumes of technical information.
Excellent communication skills, including the ability to collaborate with global and cross-functional teams.
Proficiency with Microsoft Office and foundational statistical methods (ANOVA, t-tests, CpK, PpK).
Strong analytical reasoning, technical curiosity, and the ability to work both independently and collaboratively
Location: Maplewood, MNTravel: May require up to 10% travelCompensation and BenefitsThe salary range estimated for this position based in Minnesota is $83,300.00-$125,000.00.
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:
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