Process Development Engineer

Job Title: Senior Process Development Engineer

Work Location: Bucks County, Pennsylvania

Summary:

The Senior Process Development Engineer will drive the development, validation, and improvement of manufacturing processes for advanced product lines. This role is integral to all stages of product development, from research and design to production, ensuring robust and efficient processes that meet high-quality standards. The position requires technical expertise, leadership, and a proactive approach to process innovation and problem-solving.

Responsibilities:

• Lead process validation activities, including authoring and executing IQ/OQ/PQ protocols and reports, and establishing validation acceptance criteria.
• Conduct and document process risk analyses, implement statistical sampling plans, and develop testing strategies to ensure product specifications are met.
• Establish and maintain stable, capable manufacturing processes aligned with quality and production goals.
• Apply process development best practices and continuously seek opportunities for process improvement and innovation.
• Develop and refine novel manufacturing techniques as product designs evolve, ensuring adaptability and scalability.
• Support daily manufacturing operations through process engineering initiatives and continuous improvement projects.
• Evaluate process changes, material interactions, and conduct process trials with thorough documentation and protocol adherence.
• Collaborate with cross-functional teams, including Quality and R&D, to drive process development and ensure compliance with safety and regulatory standards.

Qualifications:

• Experience working under ISO9001 and/or ISO13485 manufacturing standards.
• Medical device manufacturing experience required.
• Demonstrated leadership of engineering and technical teams in a manufacturing environment.
• Strong understanding of roll-to-roll manufacturing processes.
• Expertise in process validation/verification, FMEA, and DOE methodologies.
• Proficiency in conducting experiments and analyzing results using statistical analysis software.
• In-depth knowledge of polymer materials.
• Advanced degree in Polymer Science, Chemistry, Chemical Engineering, or a related technical discipline preferred.
• Versatile, self-motivated, and able to manage multiple project aspects simultaneously.
• Detail-oriented with strong documentation and reporting skills.
• Proficient in Microsoft Office applications, including Word, PowerPoint, and Excel.