Overview
Process Validation Engineer (Medical Device) Jobs in Waltham, MA at Kelly Science, Engineering, Technology & Telecom
Title: Process Validation Engineer (Medical Device)
Company: Kelly Science, Engineering, Technology & Telecom
Location: Waltham, MA
Process Validation Engineer
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 [email protected].
