Additional Info

Process Validation Engineer- Medical Device #9664- Onsite- West Boylston, MA
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 Process Validation Engineer will play a critical role in developing and optimizing manufacturing processes that bring life-saving medical technologies to patients around the world. This is an ONSITE role in West Boylston, MA.
What You'll Do

Lead development, optimization, and validation of manufacturing processes for new and existing products

Drive process design, equipment selection, and layout to ensure efficient, scalable production

Partner with R&D, Quality, Operations, and Supply Chain to support new product introduction (NPI) and commercialization

Identify and execute automation opportunities, including transitioning manual processes to automated solutions

Develop and implement process controls using statistical methods (SPC, DOE, capability analysis)

Lead process validation activities (IQ/OQ/PQ) and ensure compliance with regulatory standards (FDA, ISO)

Investigate process issues, perform root cause analysis, and implement sustainable corrective actions

Support continuous improvement initiatives using Lean, Six Sigma, or similar methodologies

Mentor and provide technical guidance to junior engineers and cross-functional team members

What you will bring

Bachelor's Degree with a minimum of 5 years related experience

Strong knowledge and experience in either medical device or pharmaceutical regulated manufacturing environments

Strong background in automation, equipment integration, or advanced manufacturing technologies

Experience with plastics processing (injection molding, extrusion) or complex assembly processes

Demonstrated success supporting NPI and process scale-up

Knowledge of process validation, risk management (FMEA), and quality systems

Lean Six Sigma certification or equivalent continuous improvement experience

Strong data analysis and problem-solving skills

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.

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