Process Development Engineer II

4 days ago

Maple Grove, Minnesota, United States Pharmavise Corporation Full time
Job Summary

The Process Development Engineer II will develop products, materials, processes, or equipment for projects of moderate complexity. Under limited supervision/guidance, they will compile, analyze, and report operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.

About the Role

The ideal candidate will be a highly motivated and experienced engineer with expertise in new product development to lead the design and commercialization of new cutting-edge technology and products. They will have a desire to utilize their skills to solve technical/complex problems in a hands-on manner, working in a fast-paced environment, and across multiple functions in a global company.

Responsibilities
  • Collaborate cross-functionally to develop robust designs and processes.
  • Assess process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on projects.
  • Apply technical knowledge to innovate, design, and develop processes, procedures, tooling, and/or automated equipment.
  • Write clean and concise manufacturing work instructions that can be understood by product builders.
  • Write technical reports, validations, and qualifications by capturing experimental results.
  • Write validation protocols and reports applicable to new processes.
  • Execute experiments, analyze results using standard statistical methods, report out recommendations, and generate next steps to improve performance, process efficiency, and technical understanding.
  • Gather and provide technical data for technical reviews.
  • Assist in completing proper documentation to meet quality systems requirements.
  • Oversee development builds associated with the project using special work requests.
  • Assist in developing qualified production lines.
  • Provide Design for Manufacturability (DFM) input to the engineering print package.
  • Contribute ideas to or generate Intellectual Property submissions.
  • May train manufacturing personnel when required as part of a validation.
Quality Systems Duties and Responsibilities

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Minimum Qualifications

2-5 years' experience with BS in Engineering field. Industry related experience (internships, co-ops can be included in 2-5 years of experience). Statistical background. Candidate will need to have the ability to work cross-functionally and with other sites in order to be successful.

Preferred Qualifications

Highly motivated individual that can independently drive deliverables to completion through collaboration among team members and internal support staff. Basic understanding of DFM, medical device design control, quality systems, and the product development process (PLCP) is highly desired. Strong statistics background. MINITAB experience a plus.

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