Process Development Engineer

ClinLab Solutions Group; Pennsylvania; On-site; USD 110,000 - 170,000; Full time

Job summary

ClinLab Solutions Group in the United States seeks a Senior Process Development Engineer to drive manufacturing process development, validation, and improvement across advanced product lines, from R&D to production.

You will lead IQ/OQ/PQ validation, perform DOE and FMEA, and collaborate with Quality and R&D to ensure compliance with ISO13485 and ISO9001 standards, while optimizing throughput and product quality.

Qualifications

• Experience with ISO9001 and ISO13485 quality systems.
• Medical device manufacturing experience required.
• Proven leadership of engineering teams in a manufacturing environment.
• Strong knowledge of roll-to-roll manufacturing processes.
• Expertise in process validation/verification, FMEA, and DOE methodologies.
• Proficient in data analysis and documentation.

Responsibilities

• Lead process validation activities, including IQ/OQ/PQ protocols and reports.
• Conduct process risk analyses, implement sampling plans, and develop testing strategies.
• Establish and maintain stable, capable manufacturing processes.
• Apply process development best practices and pursue continuous improvement.
• Develop and refine novel manufacturing techniques as product designs evolve.
• Support daily manufacturing operations through process engineering initiatives.
• Evaluate process changes and conduct trials with proper documentation.
• Collaborate with Quality and R&D to ensure safety and regulatory compliance.

Skills

Leadership

Process validation

DOE methodologies

FMEA

Statistics

Cross-functional lead

Documentation

Polymer materials

Education

Advanced degree in Polymer Science or related field

Tools

Statistical analysis software

Microsoft Excel

Office suite

Job description

Job Title: Senior Process Development Engineer

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.