The NPD Engineering Manager provides direction to the Engineering and Laser Technicians in the design and manufacture of medical devices. They are responsible for hiring, training, and managing the staff in the Engineering Department. Their role is to create accountability in their team to ensure that customer and internal departments are provided the engineering support they need. This includes solving manufacturing challenges, developing sound manufacturing processes that can effectively and efficiently deliver products and assisting customers through the design, validation and production ramp up of medical device products. The NPD Engineering Manager provides recommendations for capital equipment purchases and works with Production on preventative maintenance programs. They coordinate repair efforts to minimize downtime. They work closely with Sales and Account Managers to manage new product development projects and provide inputs to the quoting process. They must also work with the Quality Department to validate equipment and processes and ensure that manufacturing and inspection processes yield results that meet customer expectations as well as fall within ISO 13485:2016 requirements.
Other Functions & Responsibilities:
- The NPD Engineering Manager manages projects and is accountable for a team working together and with other departments to meet or exceed the needs of our customers.
- This Manager works with suppliers, and customers during all aspects of a project.
- Works with Purchasing on selection and specification of raw materials and outsource vendors for tooling, building fixtures and other manufacturing operations
- Supports Sales and Estimating to help quote new jobs
- Supports production through laser processing and delivery processes and applications with results to improve both current and new processes in order to fully meet customer requirements.
- Develop project timelines to meeting internal/external commit dates
- Provide verbal and written communications with internal/external customers
- Work with Purchasing to order materials, tools, and equipment as required
- Create product test plans and validate processes as required by FDA and ISO standards
- Other duties as assigned
Experience & Educational Requirements:
- Experience in effectively building and leading an Engineering department in medical device manufacturing or a similar field
- Technical training in engineering, machine building, operations
- Bachelor’s degree in Engineering, Science, Math or related experience
- Seven years plus in a management / leadership position
- Project management experience.
- ISO 13485 experience in a medical device manufacturing field a minimum for 5 years
- Bachelor of Science in Engineering
- Machine building experience
- Annual Bonus
- Life Insurance
- Paid Time Off
- Holiday Pay
Location: Cokato, MN
Employment Type: Full-time
Minimum Experience: 5 years