Senior Engineer: Medical Device Process Optimization

ProMed Molded Products, Inc.; Maple Grove (MN); Hybrid; USD 97,000 - 159,000; Full time

Benefits offered by this job

401k with company match

Medical Insurance

Vision Insurance

Life Insurance

Paid Family Medical Leave

Job summary

ProMed Molded Products, Inc. in Maple Grove, MN seeks a senior engineer to translate complex pharmaceutical and medical device concepts into scalable manufacturing processes.

You will drive DoEs, process development, and validation strategies to meet stringent regulatory standards and customer specs. Responsibilities include leading cross-functional teams, scaling development to commercial manufacturing, preparing comprehensive technical documentation, and mentoring junior engineers to build

Qualifications

• Design of Experiments (DoE) methodology knowledge with statistical analysis.
• Ability to work with cross-functional teams including Business Development, Operations, Quality, and Project Management.
• Experience in process development, equipment implementation, and process control in pharmaceutical or medical device manufacturing.
• Bachelor's degree or higher with extensive regulated industry experience as described.

Responsibilities

• Drive DoEs to identify optimal process parameters and robust manufacturing strategies.
• Collaborate with Operations to scale development toward commercial manufacturing.
• Lead design, execution, and analysis of DoEs to optimize processes.
• Develop and optimize pilot processes meeting regulatory requirements.
• Lead technical problem solving to resolve process challenges and improve efficiency.
• Provide technical leadership across feasibility and development initiatives and mentor staff.

Skills

Design of Experiments (DoE)

Process Development and Optimization

Equipment Qualification and Validation

Technical Documentation

Statistical Analysis Software

Cross-Functional Collaboration

Data Analysis and Synthesis

Technical Writing and Reporting

Laboratory Notebook Maintenance

Process Scale-Up

Client Communication and Presentation

Education

Bachelor's degree in engineering or physical science with 6+ years experience; or Master's with 3+ years; Ph.D. or 9+ years in lieu

Job description

ProMed Molded Products, Inc. in Maple Grove, MN seeks a senior engineer to translate complex pharmaceutical and medical device concepts into scalable manufacturing processes.

You will drive DoEs, process development, and validation strategies to meet stringent regulatory standards and customer specs. Responsibilities include leading cross-functional teams, scaling development to commercial manufacturing, preparing comprehensive technical documentation, and mentoring junior engineers to build