Senior Process Development Engineer

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

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‑functional 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.

To find out more about Real, please visit www.realstaffing.com