Development Process Engineer
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Job Location:
Saint Paul, MN - USA
Monthly Salary:
Not Disclosed
Posted on:
7 days ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Development Process Engineer
Location (On-site Remote or Hybrid): St. Paul MN (onsite)
Contract Duration: Contract until 04/26/2027
Working hours: 8AM - 5PM
Total hours: 40
Location (On-site Remote or Hybrid): St. Paul MN (onsite)
Contract Duration: Contract until 04/26/2027
Working hours: 8AM - 5PM
Total hours: 40
Description:
Exempt/Non Exempt: non exempt
Years Experience: 5
Skills: Experience working in a broader enterprise/cross-division business unit model work within a team individual contributor multitasks ability to prioritize strong written and verbal communication strong organizational skills attention to detail results driven
Education: Bachelor of Science in Engineering or Technical Field an equivalent combination of education and work experience
Duties: Establish processes based on product specifications evaluate process and design alternatives based on Design for Manufacturability principles understand principles of Cost of Goods Sold manage program compliance with Quality Control requirements (i.e. Design Control Process validation etc.) understand IP issues relative to processes being developed maintain knowledge of new developments in manufacturing and design technologies understand work environment issues (i.e. OSHA regulations etc.) support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS) Environmental Management Systems (EMS) and other regulatory requirements Complies with U.S. Food and Drug Administration (FDA) regulations other regulatory requirements Company policies operating procedures processes and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees customers contractors and vendors
Primary Responsibilities:
Years Experience: 5
Skills: Experience working in a broader enterprise/cross-division business unit model work within a team individual contributor multitasks ability to prioritize strong written and verbal communication strong organizational skills attention to detail results driven
Education: Bachelor of Science in Engineering or Technical Field an equivalent combination of education and work experience
Duties: Establish processes based on product specifications evaluate process and design alternatives based on Design for Manufacturability principles understand principles of Cost of Goods Sold manage program compliance with Quality Control requirements (i.e. Design Control Process validation etc.) understand IP issues relative to processes being developed maintain knowledge of new developments in manufacturing and design technologies understand work environment issues (i.e. OSHA regulations etc.) support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS) Environmental Management Systems (EMS) and other regulatory requirements Complies with U.S. Food and Drug Administration (FDA) regulations other regulatory requirements Company policies operating procedures processes and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees customers contractors and vendors
Primary Responsibilities:
- Run design of experiments (DOE) studies to characterize processes to improve yield and efficiency
- Coach mentor and provide guidance to technicians trainers and operators
- Manage projects which include new production equipment process development/improvements and cost reductions while supporting new product introductions
- Conduct equipment qualifications and process validations
- Improve product quality labor efficiency and throughput through the use of Lean manufacturing concepts and root cause investigation tools (e.g. DMAIC)
- Coordinate the design procurement build and debug of tooling machinery and test equipment
- Work cross functionally with R&D Finance Quality and Operations to define process inputs and outputs
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) Environmental Management Systems (EMS) and other regulatory requirements.
- Ensure compliance with U.S. Food and Drug Administration (FDA) regulations other regulatory requirements company policies operating procedures processes and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees customers contractors and vendors.
Required Qualifications:
- Bachelors Degree in Chemical Industrial or Mechanical Engineering or other related discipline
- 5 years manufacturing engineering experience in medical device or related industry including working on and documenting process improvement initiatives
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Previous experience working in a highly matrixed and geographically diverse business environment
- Strong analytical problem solving and project management skills
- Strong organizational and follow-up skills as well as attention to detail
- Individual should be innovative resourceful and work with minimal direction
- Individual should have excellent organization problem solving communication and team leadership skills
- Proficient with MS Office (Word Excel Outlook PowerPoint)
Preferred Qualifications:
- Medical device experience
- Previous close interface with R&D preferred
- Previous delivery system experience in design and driving yield improvements reducing cost while increasing capacity
- Lean 6 Sigma Green or Black Belt certification
