Sr. Validation Engineer - Medical Device #6561
About the company
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 transformative solutions with distinctive, sustainable, and long-term value. ECI boasts a proven track record of 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
Assists in optimization of current processes and development of new processes in support of R&D, Manufacturing, and Product Development. Provides support and guidance on validation activities related to manufacturing/test equipment and processes. The process engineer will conduct a gap analysis of existing sealing equipment and establish/document a validated test method and qualified sealing equipment to ensure reliable seal strength measurements in compliance with ISO 11607 and ASTM standards.
Responsibilities
- Conduct TMV compliance gap assessments
- Review existing service test methods and determine if validated methods can be leveraged from other products
- Identify validation gaps and determine where new TMVs are required
- Execute Test Method Validations (TMVs)
- Support Process Validation activities
- Write validation protocols, reports, and technical rationales
- Partner with technical leads supporting service and manufacturing processes
Requirements
- 5+ years direct process engineering experience in the medical device industry
- Strong engineering, design, and analysis skills
- Working knowledge of tooling and manufacturing processes
- Experience with medical devices from concept to commercialization
- Manufacturing and/or operations experience
- Experience with electrical and electromechanical testing
- Ability to assess validation strategies and make recommendations
- Advanced computer skills including MS Office applications (Word/Excel) and Minitab statistical analysis software
- Knowledge of statistical techniques and sampling for process validation and process monitoring desired
- Experience with Agile PLM or other documentation management system desired
Skills
- Accurate – Ability to perform work accurately and thoroughly
- Communication (Written/Oral) – Ability to communicate effectively in written and oral form; excellent report writing skills essential
- Problem Solving – Ability to find a solution or deal proactively with work-related problems
- Interpersonal – Ability to develop and sustain positive relationships with internal as well as external customers