Lead Process Development Engineer - Regulated Manufacturing

Real; Minneapolis (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Real is seeking a seasoned Process Development Engineer to lead manufacturing process development from early-stage development through launch. You will work cross-functionally to design, validate, and optimize processes for highly regulated products, providing technical leadership, data analysis, and continuous improvement.

The ideal candidate has 5+ years in process development or manufacturing engineering, experience in regulated environments (medical devices a plus), hands-on validation

Qualifications

• Bachelor's degree in Engineering or related field.
• 5+ years of engineering experience in process development or manufacturing engineering.
• Experience in regulated manufacturing environments; medical device a plus.
• Hands-on experience with process validation and equipment qualification.
• Strong data-driven decision making and statistical analysis skills.
• Proven ability to manage technical projects and drive results.
• Excellent communication and cross-functional collaboration abilities.

Responsibilities

• Lead development, optimization, and validation of manufacturing processes for highly regulated products.
• Drive technical problem-solving and provide solutions to complex engineering challenges.
• Apply process characterization, DOE, risk assessments, and data analysis to support decisions.
• Develop and maintain robust manufacturing processes to support new product introductions and scale-up.
• Identify and implement new equipment, tooling, and fixtures with qualification/validation.
• Author and review technical documents, validation protocols, and process reports.
• Collaborate with cross-functional teams to ensure project execution and transfer to production.
• Provide technical guidance and mentorship to engineers and foster continuous improvement.
• Partner with manufacturing teams to troubleshoot production issues and improve process performance.
• Support strategic initiatives and additional engineering projects as needed.

Skills

Process development

Manufacturing engineering

Statistical analysis

Cross-functional collaboration

Project management

Problem solving

Effective communication

Education

Bachelor's degree in Engineering

Tools

DOE (Design of Experiments)

Equipment qualification

Validation protocols

Job description

Real is seeking a seasoned Process Development Engineer to lead manufacturing process development from early-stage development through launch. You will work cross-functionally to design, validate, and optimize processes for highly regulated products, providing technical leadership, data analysis, and continuous improvement.

The ideal candidate has 5+ years in process development or manufacturing engineering, experience in regulated environments (medical devices a plus), hands-on validation