Sr. Process Engineer #8665

OverviewSr. Process Engineer #8665 role at ECIJoin to apply for the Sr. Process Engineer #8665 role at ECI.About ECIECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients rely on our diverse perspectives and decades of expertise to tackle their toughest challenges and we provide transformative solutions with distinctive, sustainable, and long-term value. ECI has a proven track record of providing full product life cycle consulting on a variety of challenging projects. Our collaborative culture, welcoming team, and flexible employment & benefit options help us maintain strong relationships with the most talented individuals in the life sciences industry.About The RoleThe candidate will be responsible for developing, optimizing, and scaling manufacturing processes for client products. This role bridges R&D and manufacturing, ensuring robust, scalable, and regulatory-compliant processes for new product introductions and existing product improvements. What You’ll Do Design, develop, and optimize manufacturing processes for IVD assays and reagents. Collaborate with R&D during design transfer to ensure manufacturability, scalability, and compliance with regulatory requirements (e.g., FDA, ISO 13485). Develop process validation protocols (IQ/OQ/PQ), DOE studies, and risk assessments (FMEA). Identify automation opportunities to improve yield, throughput, and product consistency. Generate the technical documentation list 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 years direct process engineering experience in the medical device industry. Strong analytical and problem-solving skills. Excellent written and verbal communication skills with good presentation and technical writing abilities. Collaborative attitude and ability to work effectively in a team. 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. ECI will not sponsor applicants for U.S. work visa status for this opportunity. Seniority levelMid-Senior level Employment typeFull-time Job functionManagement and Manufacturing IndustriesBusiness Consulting and Services Referrals increase your chances of interviewing at ECI. Get notified about new Senior Process Engineer jobs in Boston, MA. #J-18808-Ljbffr

Created: 2025-09-17