Process Validation Engineer; Medical Device

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.