Duties and Responsibilities:

Supervise the team of engineers within the product development department.
Responsible for the development of new products as determined by the company's product development roadmap. Continually researches for new methods or components to enhance or improve existing products.
Prepare and/or review engineering change requests; coordinate cross functional teams to determine feasibility, develop and oversee preparation and implementation of all engineering change notices and document change control.
Responsible for maintaining and implementing processes and procedures covered by design control.
Assist quality and compliance in the implementation of the quality system including but not limited to support in conducting risk analysis, closing customer complaints, CARs, internal audits, and other activities covered by the quality system.
Assist manufacturing operations with development of processes, tooling, molds, and design transfer necessary to produce new products.
Provide customer service and sales & marketing departments with orientation and training on new products, and assist with preparation of sales presentations, service/repair methods, and marketing literature.
Perform other duties as assigned Requirements
Bachelor's degree in mechanical engineering.
Minimum 5+ years of engineering experience within the medical device industry.
3+ years in a leadership role within product development, engineering, design, etc.
Experience with GMP and other regulatory compliance requirements.
Experience with design & development of medical devices within a design control process.
Prior hands-on customer interaction and proven experience understanding the voice of the customer.
Change management: willing to make hard fact-based decisions, comfortable with an uninstructed and changing environment.
Skilled at developing new ideas from both a product and process perspective.
Demonstrated practical application of design FMEA, value engineering, and design for manufacturability concepts.
Extensive experience in 3D CAD modeling and 2D dimensioning using Solidworks.

Physical /

Mental Demands:

Working conditions are normal for an office environment.
Work may require weekend and evening work.
Work may require travel.
Physical activity includes sitting, walking, standing, bending, squatting, reaching above shoulders and lifting up to 40 pounds.
Work under stress in a fast-paced environment.
Must be alert, able to concentrate, and use good judgment.

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Product Development Manager - Medical Device