Job Description

One of Swoon’s top clients, a medical device company is looking to add a Research and Development (Design Transfer) Engineer to their team in St Paul, MN!

This position will contribute to the design, development, enhancement or maintenance of products and processes in the Advanced Surgery GBU, Microsurgery portfolio. The candidate will work with Technical Leads, Product Design Owners (PDOs) and subject matter experts (SMEs) on tasks related to development, regulatory compliance, change control, design control, product maintenance, and risk management for Advanced Surgery products.

Day-to-day

• Perform standard engineering assignments which are typically a significant portion of a larger project, interfacing with development and other technical support groups.
• Support the updating and maintenance of the Design History Files and Risk Management files as necessary
• Generate protocols and reports for design verification, design validation, material qualification, and process qualification activities
• Develop design transfer plans and support transfer of new products and product configurations to production
• Coordinate and document design reviews as needed.
• Generate and manage workflows for execution of small to moderate scale projects and change control plans.
• Gather technical information from SMEs, literature, and technical resources to support project activities

What’s required?

• Solid communication skills – both written and oral
• Excellent organizational skills and attention to detail
• Ability to work effectively independently and in team environment.
• Ability to manage projects of moderate complexity with minimal guidance
• Knowledge and experience working with medical device regulatory requirements, design control, change control, and risk management.
• Display a solid technical understanding of engineering principles and procedures
• Prefer experience with Problem Solving methods (e.g. lean, six sigma)
• B.S/M.S in Biomedical/Mechanical or other engineering major
• 0 - 3 years of professional experience preferably in an R&D role at a medical device company involving combination products/biologics.

Top Skills

• Someone who has done design to production transfers, process set up, or scale-up to production

What else should you know:

• Competitive pay! Offering $42/hour W2 and medical, dental and vision benefits offered after 30 days of employment.
• The position starts as a 6-month W2 contract with the possibility for extensions!

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