ECI
Senior Process Engineer - Technical Transfer - Medical Devices #0574 Charlotte,
ECI, Charlotte, North Carolina, United States, 28245
Senior Process Engineer - Technical Transfer - Medical Devices #0574 Charlotte, NC
2 days ago Be among the first 25 applicants
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.
Brief Description 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 Senior Process Engineer will support cross-functional teams in transferring equipment used in the production of medical devices to consolidate manufacturing operations, ensuring compliance with regulatory requirements, quality standards, and business objectives. You will work in fast-paced cross-functional teams to maintain and support manufacturing process engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements. This role requires up to 50% travel on an as needed basis.
What You’ll Do
Development and Execution of Validation Protocols during tech transfer including: installation qualification, operational qualification, and performance qualification
Drive continuous improvement in transfer processes to ensure timely completion of deliverables and enhance operational efficiencies.
Ensure compliance with FDA, ISO 13485, and other applicable regulatory standards.
Ensure products and processes meet specific standards
Provide Support for testing, analysis, and continuous improvement
Support updates to ECI’s client processes or other documentation as directed
Drive completion of Process Engineering activities within prescribed timeline
Manage injection modeling machines and molds (very large equipment)
What You Will Bring
Bachelor’s degree in mechanical engineering, Life Sciences, or related field.
8+ years of experience in medical device manufacturing, product development, or technology transfer.
Proven track record supporting complex, multi-site projects in a regulated environment.
Strong knowledge of design control, process validation, and manufacturing scale-up.
Results-oriented, positive attitude focused on delivering timely, accurate and best in class execution
Exceptional communication, collaboration and problem-solving skills.
Experience with plastics processing, such as molding and/or extrusion a must.
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.
Visa Requirements 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.
Seniority level Mid-Senior level
Employment type Full-time
Job function Management and Manufacturing
Industries Business Consulting and Services
Referrals increase your chances of interviewing at ECI by 2x
Get notified about new Senior Process Engineer jobs in
Charlotte, NC .
#J-18808-Ljbffr
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.
Brief Description 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 Senior Process Engineer will support cross-functional teams in transferring equipment used in the production of medical devices to consolidate manufacturing operations, ensuring compliance with regulatory requirements, quality standards, and business objectives. You will work in fast-paced cross-functional teams to maintain and support manufacturing process engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements. This role requires up to 50% travel on an as needed basis.
What You’ll Do
Development and Execution of Validation Protocols during tech transfer including: installation qualification, operational qualification, and performance qualification
Drive continuous improvement in transfer processes to ensure timely completion of deliverables and enhance operational efficiencies.
Ensure compliance with FDA, ISO 13485, and other applicable regulatory standards.
Ensure products and processes meet specific standards
Provide Support for testing, analysis, and continuous improvement
Support updates to ECI’s client processes or other documentation as directed
Drive completion of Process Engineering activities within prescribed timeline
Manage injection modeling machines and molds (very large equipment)
What You Will Bring
Bachelor’s degree in mechanical engineering, Life Sciences, or related field.
8+ years of experience in medical device manufacturing, product development, or technology transfer.
Proven track record supporting complex, multi-site projects in a regulated environment.
Strong knowledge of design control, process validation, and manufacturing scale-up.
Results-oriented, positive attitude focused on delivering timely, accurate and best in class execution
Exceptional communication, collaboration and problem-solving skills.
Experience with plastics processing, such as molding and/or extrusion a must.
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.
Visa Requirements 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.
Seniority level Mid-Senior level
Employment type Full-time
Job function Management and Manufacturing
Industries Business Consulting and Services
Referrals increase your chances of interviewing at ECI by 2x
Get notified about new Senior Process Engineer jobs in
Charlotte, NC .
#J-18808-Ljbffr