Skip to content

Job Openings

Process Development Engineer

Minnetonka, MN 55343

Posted: 02/04/2025 Employment Type: Contract Job Category: Engineering Job Number: 617419 Is job remote?: Hybrid Country: United States

Job Description

POSITION SUMMARY:
This position will lead efforts to design, develop, implement, and maintain processes and equipment used to manufacture existing products and products in development. Products include but are not limited to combination pharmaceutical/medical devices used for self-injection. Processes include but are not limited to mid to high volume complex assembly, packaging, and labeling. ESSENTIAL DUTIES AND

RESPONSIBILITIES:
Responsibilities include, but are not limited to: 
  • Collaborate with cross-functional teams to understand user/product requirements and recommend design for manufacturability elements for the product design
  • Design and develop manufacturing processes and equipment that are lean and mistake-proof
  • Develop equipment specifications and work with suppliers to quote, procure, and implement
  • Develop process validation plans, lead the execution of plans, and document results in reports
  • Lead cross-functional teams to develop pFMEA’s and other risk assessments and implement effective manufacturing controls
  • Collaborate with Operations team to develop effective process work instructions
  • Implement equipment calibration and maintenance plans/schedules
  • Design experiments and gather/assess/summarize data using statistical tools to make conclusions and decisions
  • Develop and validate test methods used in manufacturing
  • Lead cross-functional teams to develop and manage project plans and schedules
  • Identify and implement continuous improvement projects compliant with change management procedures
  • Develop cost of goods estimates and cost/benefit analyses
  • Provide guidance and mentorship to other engineers and technicians
  • Lead CAPA projects and problem-solving efforts
EDUCATIONAL REQUIREMENTS (degree, license, certification):
  • Bachelor’s degree in Engineering or related technical field
YEARS OF EXPERIENCE:
  • 5-10 years in process development or manufacturing
OTHER SKILLS AND ABILITIES:
  • Experience in medical device, pharmaceutical, GMP, or regulated industry preferred
  • Experience with process validation (IQ/OQ/PQ) preferred
  • Experience with design and troubleshooting automated equipment preferred
  • Six Sigma Black Belt preferred
  • Proficient in the use of Minitab, MS Project, and SolidWorks preferred
  • Experience with Lean principles and metrics, problem solving methodologies, DMAIC, SPC, process capability analysis
  • Ability to communicate across all levels of the business and externally with customers and suppliers
  • Ability to author technical plans and reports
  • Ability to travel up to 10% as projects require













Pay Rate Range: $50-65/hr depending on experience 
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Minnetonka, MN

Discover exciting job opportunities in the enchanting Minnetonka, Minnesota area! Embrace a thriving professional scene amidst the picturesque landscapes and vibrant culture this region has to offer. From the iconic Minnehaha Falls to the renowned Guthrie Theater, there's no shortage of attractions to explore during your off hours. Indulge in the local delicacies like Juicy Lucy burgers and explore the numerous art galleries and parks that make this area truly unique. Whether you're a sports enthusiast cheering for the Vikings at U.S. Bank Stadium or seeking tranquility in the stunning Lake Minnetonka, this region promises growth opportunities and a fulfilling career path. Start your journey today by exploring our latest job listings in Minnetonka, MN!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.