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Thermo Fisher Scientific jobs

Product Development Engineer

$83,300 - 125,000
Thermo Fisher Scientific
Saint Anthony Avenue 1661, Saint Paul
$83,300 - 125,000
Company Size icon
Company Size
5k+
Company Type icon
Company Type
Product
Exp Level icon
Exp Level
Senior
Job Type icon
Job Type
Full-Time
Language icon
Language
English
Visa sponsorship icon
Visa sponsorship
No

Requirements

Must:
- High school diploma and 10+ years of equivalent industry experience, or - Bachelors 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. - 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. - Proven success in roles requiring substantial technical documentation, such as 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. - Demonstrated analytical problem-solving skills and methodical technical decision-making.

Technologies

Responsibilities

- Lead and coordinate product and process change management initiatives, including raw material changes, quality enhancements, supplier transitions, cost savings, and regulatory updates affecting one or more manufacturing locations. - Author, maintain, and systematize detailed product documentation encompassing engineering assessments, technical reports, justification documents, protocols, and change qualification packages. - Collaborate closely with global manufacturing facilities to execute and validate modifications. - Work alongside interdisciplinary teams both domestically and internationally to uphold global product consistency. - Prepare and deliver documentation and findings in both digital and written formats. - Ensure rigorous compliance with quality and regulatory standards (ISO 9001 with key elements of ISO 13485). - Drive continuous enhancement using methodologies such as project management, Agile/SCRUM, Six Sigma, DOE, and Process & Product Understanding (PPU).

Description


We are Thermo Fisher Scientific, located in Maplewood, MN, and we are excited to invite you to join our dynamic and innovative Engineering division. With a strong emphasis on collaboration and technical excellence, our team is committed to delivering high-quality outcomes. Our Product Engineer role supports the lifecycle of our Biopharmaceutical Filtration and Separation products, ensuring compliance, consistency, and alignment through regulatory, material, and manufacturing changes. We offer a competitive salary ranging from $83,300.00 to $125,000.00, along with a great benefits package, including comprehensive health plans, paid time off, and retirement savings programs. Were dedicated to supporting our staff and their families in all aspects.
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