Senior Process Development Engineer, Regulated Manufacturing

Real; Minneapolis (MN); On-site; USD 90,000 - 140,000; Full time

Job summary

Real is seeking a candidate to lead process development from early development through manufacturing launch, working cross-functionally to validate, optimize, and improve processes for highly regulated products.

The role emphasizes hands-on problem solving, data analysis, and continuous improvement, with mentoring of engineers and collaboration with manufacturing teams to transfer new processes to production.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 5+ years of engineering experience in process development or manufacturing engineering.
• Experience in regulated manufacturing environments; medical device experience is a plus.
• Hands-on experience with process validation and equipment qualification.

Responsibilities

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

Skills

DOE

Data analysis

Statistical methods

Problem solving

Project management

Communication

Mentorship

Education

Bachelor's degree in Engineering

Job description

Real is seeking a candidate to lead process development from early development through manufacturing launch, working cross-functionally to validate, optimize, and improve processes for highly regulated products.

The role emphasizes hands-on problem solving, data analysis, and continuous improvement, with mentoring of engineers and collaboration with manufacturing teams to transfer new processes to production.