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
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.
What You'll Do:
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Conduct TMV compliance gap assessments
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Review existing service test methods and determine if validated methods can be leveraged from other products
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Identify validation gaps and determine where new TMVs are required
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Execute Test Method Validations (TMVs)
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Support Process Validation activities
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Write validation protocols, reports, and technical rationales
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Partner with technical leads supporting service and manufacturing processes
What We Look For:
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Accurate – Ability to perform work accurately and thoroughly.
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Communication (Written /Oral) – Ability to communicate effectively in written and oral Form. Excellent report writing skills essential.
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Problem Solving – Ability to find a solution or deal proactively with work related problems.
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Interpersonal – Ability to develop and sustain positive relationships with internal as well as external customers.
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Advanced computer skills including MS Office applications (Word/Excel) and Minitab statistical analysis software are required.
- Knowledge of statistical techniques and sampling for process validation and process monitoring desired.
- Experience with medical devices from concept to commercialization.
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Manufacturing and/or operations experience
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Experience with electrical and electromechanical testing
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Ability to assess validation strategies and make recommendations
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Experience with Agile PLM or other documentation management system desired.
- 5+ years direct process engineering experience in medical device industry.
- Strong engineering, design, and analysis skills.
- Working knowledge of tooling and manufacturing processes.
ECI does not accept unsolicited resumes from third-party recruiting agencies not currently under a signed agreement. Any unsolicited resumes that are sent to directly to ECI or its employees by a third-party recruiting agency not currently under a signed agreement with ECI, will be considered property of ECI. If a third-party recruiting agency submits a resume without an agreement, ECI reserves the right to pursue and hire those candidate(s) without any financial obligation to the third-party recruiting agency.
Enhanced Compliance Inc. is an equal opportunity employer.
