Process Validation Engineer (Medical Devices)

By | June 1, 2026

Process Validation Engineer (Medical Devices)

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Job ID: 10245624

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Waltham, MA, US

Engineering

Bachelors Degree

Full Time, Temporary

$45 - $50/hr

Experienced (Non-Manager)

On-site

Biotechnology/Pharmaceuticals

First Shift (Day)

Waltham, MA, US

$45 - $50/hr

Experienced (Non-Manager)

Full Time, Temporary

Biotechnology/Pharmaceuticals

On-site

Engineering

Bachelors Degree

First Shift (Day)

Apply Now Applied

Job details

Process Validation Engineer (Medical Devices)

 

  • Location: 100% ONSITE – Waltham, MA (02451)

  • Duration: 12 month contract – (extension potential)

  • Pay: Negotiable depending on DIRECT related experience Up to $45 – $50/hr

  • Type: W2 contract ONLY – (C2C OR THIRD-PARTY arrangements will NOT be considered)

  • Work Authorization: Must be currently located and authorized to work in the United States without sponsorship requirements.

 

 

Job Summary and Required Experience:

  • Strong understanding of medical device manufacturing process development, transfer, optimization, and validation (IQ/OQ/PQ).

  • Demonstrated experience supporting both internally developed and externally sourced manufacturing processes within regulated environments.

  • Solid foundation in statistical methods and data-driven problem solving, including DOE, process characterization, process capability analysis, and root cause investigation.

  • Proficient in use of Minitab, or similar statistical software.

  • Working knowledge of risk management and design control methodologies, including FMEA, control plans, and design transfer activities.

  • Experience with complex medical device manufacturing processes such as catheter assembly, balloon processing, laser processing, extrusion, thermal forming/heat setting, bonding, precision assembly, and/or injection molding preferred.

  • Familiarity with electro-mechanical and capital equipment manufacturing processes preferred.

  • Ability to troubleshoot complex manufacturing and process-related issues and implement effective corrective and preventive actions.

  • Ability to read, understand, and create engineering drawings using common engineering software, including GD&T interpretation for tight-tolerance components.

  • Ability to conduct complex statistical, geometric, and mathematical calculations.

  • Demonstrated project and task management skills across multiple concurrent initiatives.

  • Strong technical communication skills, including the ability to write and review protocols, reports, specifications, and technical documentation.

 

 

*** Kelly does not expense relocation/interview costs. ***

 

 

Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.

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