Job Description

Process Development Engineer – NPD/NPI

Location: Irvine, CA | Los Angeles, United States

Experience: 4–6 Years of Experience

Job Summary:

We are seeking a highly motivated Process Development Engineer to support New Product Development (NPD) and New Product Introduction (NPI) projects within a regulated medical device manufacturing environment. The successful candidate will be responsible for end-to-end process design, characterization, equipment and product validation, and implementation of Good Manufacturing Practices (GMP) and documentation standards. This role will work cross-functionally with engineering, quality, manufacturing, and regulatory teams to ensure compliance and drive continuous improvement initiatives

Key Responsibilities:

• Lead process development activities for new product introduction, including process design, scale-up, and technology transfer.
• Plan and execute Process Validation (IQ/OQ/PQ) and Equipment Qualification in compliance with FDA , GMP , and ISO 13485 regulations.
• Conduct Design of Experiments (DOE) , Statistical Process Control (SPC) , and process capability analysis to support robust process development and root cause investigations.
• Collaborate with R&D, Quality, and Manufacturing teams to ensure design and process requirements are met throughout the product lifecycle.
• Author and maintain technical documentation, including process flow diagrams, validation protocols, risk assessments, and reports.
• Utilize PLM tools (preferably Windchill ) for document control, change management, and project tracking.
• Support the development and optimization of standard operating procedures (SOPs), work instructions, and training documents.
• Drive continuous improvement initiatives using Lean and Six Sigma methodologies to improve yield, reduce cost, and enhance quality.
• Communicate project updates, risk mitigation strategies, and validation outcomes to cross-functional stakeholders and leadership.

Required Qualifications:

• Bachelor’s Degree in Engineering, Life Sciences, or a related technical field.
• 4–6 years of experience in process or manufacturing engineering within the medical device or regulated industry .
• Proven expertise in NPI/NPD , process characterization , and validation .
• Working knowledge of GMP , ISO 13485 , and FDA regulatory requirements.
• Hands-on experience with validation and statistical tools such as Minitab , FMEA , SPC , and Gage R&R

Preferred Skills:

• Experience working with PLM systems , preferably Windchill .
• Familiarity with standard costing and cost reduction techniques.
• Ability to independently analyze data and develop process improvement strategies.
• Proficiency in MS Office Suite (Excel, Word, PowerPoint, Outlook).
• Excellent interpersonal, communication, and organizational skills.

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