Senior Process Development Engineer

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

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.