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.

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).

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.

Please apply online at Careers | ECI | Enhanced Compliance Inc.   Req#8665  

Expertise. Passion. Accountability.

At ECI, we employ passionate professionals who understand why we do what we do. We engage individuals eager to explore their own potential, relish the process of continual learning, and embrace challenges with enthusiasm.

Our collaborative team engages with industry trailblazers seamlessly merging science, technology, and a profound understanding of compliance regulations across diverse projects. The outcomes of our endeavors—innovative, life-changing, and life-saving advancements—positively impact people's lives. Join us to nurture your career growth at ECI.

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.