Manager, Sustaining Manufacturing Engineering

The Manager Sustaining Manufacturing Engineering is responsible production support for complex electro-mechanical Medical instruments/devices including mechanical, electrical, tubing, and disposable consumable assembly processes. This position involves a strong focus towards process, process improvement and day to day support of production line activities. This position will coordinate the ongoing product and process improvements to meet quality and production goals. The Supervisor/Manager Sustaining Manufacturing Engineer will also be responsible to provide day to day direction and prioritization to a team of Manufacturing Engineers responsible for production support of products produced at NorthStar’s Beloit, WI facility.
All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:

1. Execute production support of electro-mechanical assemblies, chemical/fluid, filling, packaging processes in both factory and pharmaceutical clean room environments.
2. Develop and maintain cGMP compliant process work instructions, batch production records, reports, and plan documentation
3. Execute ongoing product & process improvements to meet quality and production goals.
4. Execute Factory/Site Acceptance Testing of complex custom equipment.
5. Develop/execute standards/processes for qualification and process validation
6. Proactively identify technology and process gaps in the manufacturing processes and establish system level metrics and test plans by collaborating with engineering and RA/QA teams to ensure the product meets performance requirements involving accuracy, repeatability, and reliability.
7. Analyze and improve material/people flows, process layouts to optimize plant efficiency
8. Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
9. Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
10. Ensure production equipment is capable and has capacity for growth, involving integrating equipment, people, material flow systems, and information systems.
11. Assist other Engineering and Service personnel with troubleshooting and support of all NorthStar products, within the production environment.
12. Support complaint/event/CAPA/deviation/out of specification investigations
13. Lead/mentor team in troubleshooting and disciplined problem solving activities to resolve current manufacturing issues.
14. Responsible for day to day management and work assignment of assigned manufacturing engineers supporting production including performance development (appraisal).
15. Support NorthStar’s Quality System and Health and Safety Program by following procedures and mentoring others.

Ability to travel internationally and domestically could be required, this is expected to be less than 10% of the time.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Bachelor’s Degree in Engineering and a minimum of 8 years of experience as a Manufacturing Engineer; or equivalent combination of education and experience. Experience executing process validation and documentation activities (IQ/OQ/PQ) is required. Strong experience with FDA regulations, cGMP regulations, and pharmaceutical/medical device industry is preferred.

Proficient knowledge of Microsoft Office Suite software programs

• Strong Multi-tasking skills
• Excellent problem solving skills
• Strong organizational and communication skills.
• Strong Mentorship skills.

If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line



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