Process Validation Engineer- Class III-Medical Device #2323

About the role

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.

Responsibilities

• 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 a 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.

Requirements

• Bachelor’s Degree in Engineering or equivalent work experience.
• Minimum of 7 (seven) 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.

Qualifications

• Not specified

Skills

• Measurement System Analysis (MSA)
• Operational Qualification (OQ)
• Class III medical device manufacturing environments

Benefits

• Not specified

Pay

• Not specified

Schedule

• Not specified

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. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.