Process Validation Engineer- Medical Device #2323

Process Validation Engineer- Medical Device #2323 Enhanced Compliance Inc. - 3.6 West Boylston, MA Job Details Full-time 22 hours ago Qualifications New product introduction engineering projects Medical device manufacturing facility experience Biomedical regulatory compliance Biomedical manufacturing processes Full Job Description About ECI ECI's mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry. 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. Ideal candidate will possess strong, hands-on experience in the following: Measurement System Analysis (MSA) Operational Qualification (OQ) Class III medical device manufacturing environments What you'll do 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. What you will bring 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. 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.