Lead Process Development Engineer — Medical Devices

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

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.