Senior Process Development Engineer

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

This role offers the opportunity to lead process development efforts for innovative products, from early-stage development through manufacturing launch. You'll work cross-functionally to develop, validate, and improve manufacturing processes while providing technical leadership, analyzing data, and driving successful product commercialization. The ideal candidate enjoys hands-on problem solving, collaboration, and continuous improvement.

Key Responsibilities

• Lead the development, optimization, and validation of manufacturing processes for highly regulated products.
• Drive technical problem-solving efforts and provide solutions to complex engineering and manufacturing challenges.
• Apply process characterization methodologies and statistical tools, including DOE, risk assessments, and data analysis, to support decision-making.
• Develop, implement, and maintain robust manufacturing processes to support new product introductions and product scale-up activities.
• Identify, evaluate, and implement new equipment, tooling, and fixtures, including qualification and validation activities.
• Author and review technical documentation, 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.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline preferred.
• 5+ years of engineering experience in process development, manufacturing engineering, or a related field.
• Experience in regulated manufacturing environments strongly preferred, with medical device experience being a plus.
• Hands-on experience with process validation, equipment qualification, and manufacturing process development.
• Strong understanding of statistical analysis and data-driven decision-making methodologies.
• Proven ability to manage technical projects, prioritize workstreams, and drive results.
• Excellent communication skills, with the ability to present technical concepts to diverse audiences.
• Demonstrated success working cross-functionally and influencing stakeholders at multiple levels of an organization.
• Experience supporting continuous improvement initiatives and implementing process enhancements.
• Willingness to travel between local manufacturing and engineering sites as business needs require.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.