Process Development Engineer

Pay Rate Low: 110000 | Pay Rate High: 135000

Position Summary

The Process Development Engineer is responsible for developing, qualifying, and transferring robust manufacturing processes for new products and for existing processes requiring significant development.

Responsibilities

• Develop, optimize, and qualify manufacturing and inspection processes for new and existing products
• Review and interpret product functional and design specifications
• Lead and provide oversight for process development projects from concept through production handoff
• Collaborate with cross-functional teams, including operations, quality, manufacturing, and engineering, to ensure robust process design and execution
• Coordinate with external vendors and contract manufacturers to ensure alignment on requirements, timelines, and quality expectations
• Communicate project timelines, requirements, and status to internal teams, customers, and senior management
• Ensure resource needs are identified and supported in collaboration with operational and quality leadership
• Lead process validation and qualification activities, ensuring compliance with internal, customer, and regulatory requirements
• Perform process characterization, SPC analysis, and continuous improvement activities to meet quality and cost targets
• Support vendor audits, root cause analysis, and customer alignment activities, including occasional travel
• Manage multiple projects within design specifications, timelines, and budget constraints
  
  

Qualifications

• Bachelor’s degree (B.S.) in Engineering or a related technical field
• 7–15 years of experience in process development or manufacturing engineering
• Experience in a highly regulated industry; medical device experience preferred
• Experience with contract manufacturing and external vendor management
• Proven experience leading large-scale projects involving CAPEX, process development, and extensive qualification requirements
• Strong understanding of manufacturing process development, validation, and qualification methodologies
• Working knowledge of PFMEA, Control Plans, MSA, SPC, PPAP, OQ/PQ, and First Article Inspections
• Strong project planning, organizational, analytical, and problem-solving skills
  
  

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

INDBH