Job Description:

• 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.

Responsibilities:

• 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.

Requirements:

• 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