Job description

We are looking for both a Principal and Senior Product Development Engineer for our medical device manufacturing client that is growing and planning to introduce new products!

The desired individual will possess a broad range of medical device design and development skills and experience. Applies knowledge and expertise acquired through progressive experience to resolve crucial design issues and/or unique conditions. Keeps informed of new methods and developments affecting their projects. Routinely serves as technical lead. Provides direction/ training for technicians and PDE I level resources with support from management. The ideal candidate is a self- motivated individual who is excited by the prospect of working in a dynamic, entrepreneurial environment.

• Ability to provide technical input on catheter design such as material selection, reinforcement, and manufacturing processes,

• Demonstrates a complete understanding of the relationship between all deliverables required to complete the DHF and can provide well-justified recommendations for modifications of DHF deliverables and deliverables list.

• Lead improvement projects for complex production processes. Assist in the establishment of process improvement priorities based on production and quality metrics

• Lead activities for individual customer Corrective Action Requests

• Participate and lead design reviews and provide guidance to improve designs to meet usability requirements while considering design for manufacturability aspects.

• Able to identify opportunities and drive changes for continuous improvement of quality systems and procedures

• Interface with customers to determine design inputs

• Coordinate development activities to meet customer requirements

• Generate technical documentation (i.e. Design History File, Risk Management Documents, Product/Process Validation Protocols/Reports)

• Develop new technologies/processes to expand manufacturing capabilities

• Develop detailed manufacturing processes and inspection protocols for medical devices

• Implement and qualify new equipment, fixtures, and tooling for manufacturing

• Develop solid models and prints using Solidworks

• Procure equipment and raw materials

• Perform process/manufacturing risk analysis and coordinate with manufacturing and quality to mitigate risk

• Identify key product features and generate test methods to verify design output meets design inputs

• Update design documentation and submit engineering change orders

• Mentor junior engineers, modeling and encouraging creativity, innovation, data drive decision making, and careful use of the scientific method

• Represent company as a senior technical lead in customer discussions.

• Design for plastic injection molding and over-molding.

Minimum Requirements

• Experience: a Minimum of 6 years in the medical device manufacturing industry, emphasis on balloon catheter and implant delivery systems based products.

• Bachelor’s / Master's Degree in Engineering or related field

• Injection Molding, machining and 3D Printing is preferred

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Experience level:

• 5 years

Schedule:

• Day shift
• Monday to Friday

Ability to commute/relocate:

• Brooklyn Park, MN: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Do you have experience with heart catheter design or development?

Experience:

• Manufacturing: 5 years (Required)

Work Location: In person

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