What are the responsibilities and job description for the Process Development Engineer - Minnetonka, Hybrid position at Hydrogen Group?
Location: Minnetonka, MN/Hybrid
Schedule: Standard Office Hours
Duration: 2-Month Contract
Pay range: $55.00 - $65.00 per hour
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:
- 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
- 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
...
Salary : $55 - $65
