Manufacturing Engineer II - Onsite

Starkey is adding a Manufacturing Engineer II to its manufacturing engineering team at its global headquarters in Eden Prairie, MN. Do you have a background in medical device, process validation, 3D modeling, and the ability to lead process improvements? If so, this could be your next career move.

This position is responsible for assisting in the development and application of new processes and equipment for the manufacturing and assembly of our products. Serve as a point of communication between manufacturing departments and all other areas to facilitate, analyze, and offer solutions to manufacturing problems.

Starkey is a world leader in the manufacturing and distribution of advanced hearing technologies. We are in the business of connecting people and changing lives. Our teams come to work each day focused on ensuring people everywhere have the products and services they need to hear better and live better. We were founded in 1967 and are headquartered in Eden Prairie, Minnesota, with over 5,000 employees in 29 facilities across the globe and business in more than 100 markets worldwide.

Job responsibilities include ongoing process improvement for our custom, standard, and accessory products. This role will interact with design, quality, manufacturing, and contract manufacturers to ensure manufacturability and performance goals are met.

• Continually improve the manufacturing processes of our custom, standard, and accessory products.
• Support PFMEA efforts during product development to reduce process risks.
• Represent Manufacturing Engineering (voice of manufacturing) to other development teams within R&D and contract manufacturers.
• • Act as technical manufacturing lead at the program level
  • Interface with R&D teams while developing and maintaining positive interdepartmental collaboration
  • Interface with contract manufacturers while developing and maintaining positive collaboration
  • Provide recommendations regarding contract manufacturing capabilities
  • Support and provide input for DFM improvements through Program / Project charters and system requirements specifications
• Lead, drive improvement efforts on existing manufacturing processes that are justified and implement new fully tested processes.
• Partner with Design Engineering on new product development. Participate in design reviews, establish manufacturing requirements, and coordinate needed testing or device builds.
• Partner with Quality Engineering to identify and implement ongoing quality improvements
• Qualify and validate new and improved processes, fixtures, equipment and technology for manufacturability

Drive testing and troubleshooting of product to characterize the device.

• Generate test plans and procedures to characterize the unit.
• Coordinate product testing and report generation.
• Identify opportunities and implement solutions

Optimization of key manufacturing measures. Organize and report on key manufacturing measures.

• Identify and drive opportunities to manage and reduce the internal rework of Starkey’s hearing aids.
• Identify and drive opportunities to manage and reduce the internal material variance of Starkey’s hearing aids
• Lead conference calls with manufacturing facilities to determine root cause and action items

Participate in solving product and process issues.

• Lead / Facilitate Starkey and contract manufacturing Production PIPs (Product Improvement Programs) on a regular basis.
• Production and recovery support.
• Initiate internal and external product and process audit to drive improvements and other problem-solving techniques to improve internal quality.
• Provide yield expectations and analysis, time studies, and capacity.
• Lead and define Manufacturing system design and maintenance strategies
• Perform other duties/responsibilities as assigned.

Minimum Education, Certification and Experience Requirements

• Education
  • Bachelor's degree in electrical, mechanical, or manufacturing engineering
• Experience
  • Three plus years of manufacturing engineering experience
  • One year hearing aid industry or medical device industry experience preferred

Knowledge / Technical Requirements

• Knowledge of process validation required
• Knowledge of relevant product development methods and best practices
• Experience solving technical problems
• Experience managing multiple projects simultaneously
• Experience with 3D modeling and solutions required
• Experience with 3D printing techniques and technologies
• Excellent analytical skills required

Work Context

Working Conditions

• Standard office conditions

Equipment Operation

• Standard office equipment

Salary and Other Compensation

The target rate for this position is between $78,540 to $104,475/year. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.

Benefits The following benefits for this position, subject to applicable eligibility requirements, include medical, dental and vision insurance, 401(k) retirement plan with company match,…