POSITION SUMMARY

The Process Development Engineer will lead the design, development, and validation of robust manufacturing processes to support new product development and continuous improvement initiatives. This role is critical in ensuring products are designed and manufactured with quality, reliability, and cost efficiency in compliance with industry regulations.

QUALIFICATIONS

• Bachelor’s degree in Engineering (minimum); advanced degree preferred.
• 4+ years of experience in process development, manufacturing, or quality engineering within a regulated industry (medical device experience strongly preferred).
• Strong knowledge of process validation (IQ, OQ, PQ) and test method validation.
• Experience creating detailed work instructions and technical documentation.
• Solid understanding of statistical techniques and analysis; proficiency with DOE.
• Proficient in Minitab, Excel, Word, and MS Project.
• Experience with Design for Reliability and Manufacturability (DRM).
• Excellent problem-solving, analytical, and communication skills.

• Lead the exploration, evaluation, and integration of new process technologies into product development or existing manufacturing lines.
• Partner with cross-functional engineering teams to design and develop manufacturing processes that optimize yields, cost, and quality.
• Plan and execute manufacturing studies to characterize process inputs and define critical process specifications using Design of Experiments (DOE) and statistical methods.
• Identify, develop, and qualify required equipment, tooling, and fixtures for pilot and production operations.
• Generate and maintain documentation including engineering protocols/reports, PFMEAs, work instructions, and other regulatory-compliant records.
• Develop and execute equipment qualifications (IQ, OQ, PQ) and process validation activities.
• Lead test method development and validation to ensure robust product testing.
• Ensure compliance with Good Manufacturing Practices (GMP), internal quality procedures, and applicable regulations.