Product Development Engineer

Product Development Engineer

We are seeking a Product Development Engineer to lead and support new product development, product improvements, and line extensions within a medical device manufacturer. This role partners cross-functionally with engineering, manufacturing, quality, and commercial teams to bring products from concept through production.

Key Responsibilities

• Lead or support product development projects, enhancements, and engineering changes
• Translate customer and user needs into product design requirements
• Develop product concepts, testing methods, validation plans, and technical documentation
• Collaborate with manufacturing teams on design transfer and production readiness
• Manage timelines, priorities, and project deliverables across multiple initiatives
• Ensure compliance with FDA and ISO design control and risk management requirements
• Work with external vendors, labs, and consultants as needed

Qualifications

• Bachelor's degree in Engineering (Mechanical, Biomedical, Manufacturing, Materials Science, or related field)
• 3+ years of engineering experience within the medical device industry
• Experience with FDA design controls, ISO 13485, and risk management processes
• Strong problem-solving, project management, and communication skills
• Proficiency with CAD software such as Solid Works, AutoCAD, or similar
• Ability to travel up to 10%

Location:

Remote role with preference for candidates located within driving distance of Wisconsin or Northern Illinois to visit plants as needed.