Process Validation Engineer - Medical Device

The candidate will be responsible for developing, optimizing, and scaling manufacturing processes for the client products. This role bridges R&D and manufacturing, ensuring robust, scalable, and regulatory-compliant processes for new product introductions and existing product improvements. This is an Onsite contract role (5 days per week). Ideal candidate will possess strong, hands‑on experience in the following:

• Design, develop, and optimize manufacturing processes
• Collaborate with R&D during design transfer to ensure manufacturability, scalability, and compliance with regulatory requirements (e.g., FDA, ISO 13485).
• Support manufacturing tech transfer.
• Develop process validation protocols (IQ/OQ/PQ), DOE studies, and risk assessments (FMEA).
• Support current process‑related CAPAs, NCRs (NCMRs) as a CAPA/NCR owner.
• Identify automation opportunities to improve yield, throughput, and product consistency.
• Generate a list of the required technical documentation including SOPs, batch records, validation reports, and engineering change orders.
• Evaluate new equipment, materials, and technologies for integration into manufacturing processes.

• Bachelor’s Degree in Engineering or equivalent work experience.
• Minimum of 7 years direct process engineering experience in medical device industry.
• Good analytical and problem‑solving skills.
• Excellent written and verbal communication skills with good presentation and technical writing skills.
• Collaborative attitude with the ability to work well in a team environment.
• Strong engineering, design, and analysis skills.
• Working knowledge of tooling and manufacturing processes.
• Experience with medical devices from concept to commercialization.
• Understanding of FDA Quality Systems Regulations.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law.