Lead Process Development Engineer (Regulated Manufacturing)

Real Staffing; Minneapolis (MN); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision coverage

Paid leave

Job summary

Specialist Staffing Group seeks a process development leader to drive manufacturing process development, optimization, and validation for highly regulated products. You will guide cross-functional teams, apply DOE and data analysis, and ensure smooth transfer to production.

The role emphasizes hands-on problem solving, collaboration, and continuous improvement with travel between local sites as business needs require.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 5+ years in process development or manufacturing engineering.
• Experience in regulated manufacturing environments; medical device a plus.
• Hands-on process validation and equipment qualification.
• Strong statistics and data-driven decision making.
• Excellent communicator with cross-functional influence.

Responsibilities

• Lead development, optimization, and validation of manufacturing processes.
• Solve complex engineering and manufacturing challenges.
• Apply DOE, risk assessments, and data analysis for decisions.
• Develop and maintain robust processes for new product introductions and scale-up.
• Identify and qualify new equipment, tooling, fixtures.
• Prepare validation protocols, studies, and process development reports.
• Collaborate with cross-functional teams and transfer to production.
• Provide technical guidance and mentorship to engineers.
• Support strategic initiatives and other engineering projects.
• Travel between local manufacturing and engineering sites as needed.

Skills

Process development

Manufacturing engineering

DOE

Statistical analysis

Data-driven decisions

Cross-functional teamwork

Project management

Communication

Problem solving

Education

Bachelor's degree in Engineering

Tools

Equipment qualification

Validation protocols

Data analysis software

Job description

Specialist Staffing Group seeks a process development leader to drive manufacturing process development, optimization, and validation for highly regulated products. You will guide cross-functional teams, apply DOE and data analysis, and ensure smooth transfer to production.

The role emphasizes hands-on problem solving, collaboration, and continuous improvement with travel between local sites as business needs require.