Senior Process Development Engineer

LifeLens Technologies Inc.•Ivyland, PA

3d•Onsite

About The Position

LifeLens Technologies, Inc. is a medical device developer located in Ivyland, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring. We are seeking to hire a Senior Process Development Engineer. In this role, you will have the opportunity to work on cutting-edge technologies designed to revolutionize wearable health care. You have a collaborative mindset and a passion for developing new technology. You are detail-oriented and goal-driven. You are a capable problem solver with excellent organizational skills and superior verbal and written communication skills. Your passion and drive will be rewarded with a competitive salary, benefits, and long-term growth opportunities. This is a full-time, on-site position.

Requirements

Medical device manufacturing experience required.
Experience leading a team of engineers and technicians in a manufacturing environment.
Solid understanding of roll-to-roll manufacturing processes.
Process validation/verification and FMEA.
Experience with DOE, conducting experiments, and analyzing results using statistical analysis software.
Must be knowledgeable of polymer materials
Must be a versatile, self-starter who can manage several different aspects of the given project
Must be detail oriented
Must be functional with Microsoft Office, including Word, Power Point, and Excel

Nice To Haves

Worked under ISO9001 and/or ISO13485 manufacturing standards.

Responsibilities

Lead process validation activities including authorship and completion of installation, operational, and performance qualification (IQ/OQ/PQ) protocols and reports.
Evaluate process requirements and determine appropriate validation acceptance criteria.
Lead and document process risk analysis activities including implementation of statistical sampling plans and testing strategies to ensure process outputs meet product specifications.
Establish stable and capable processes meeting company manufacturing and quality goals.
Implement process development discipline and best practices.
Explore and develop novel processes as designs evolve.
Support daily manufacturing activities through process engineering development and continuous improvement projects.
Evaluate process changes and material/composition interactions.
Conduct process trials with appropriate protocols and documentation.
Implement safety protocols for manufacturing equipment.
Work with Quality and R&D in process development.
Conduct process DOEs and author process reports for studies
Other tasks as assigned