R&D Engineer Mid-Level

Prevailing Medical is seeking a hands-on mid-level R&D Engineer to advance catheter-based medical devices from concept to commercialization, collaborating with customers and cross-functional teams in a fast-paced environment.

Responsibilities

• Lead and support project planning, scheduling, and execution to meet milestones and deliverables on schedule.
• Design, develop, and refine catheter-based devices and associated manufacturing processes.
• Advance product development from concept through commercialization.
• Fabricate prototypes and perform design verification, validation, and performance testing.
• Prepare and maintain engineering documentation, including drawings, test protocols, reports, risk analyses, and Design History File documentation.
• Collaborate with customers, and with Quality, Regulatory, and Manufacturing teams to ensure project success.
• Lead root cause investigations and implement corrective actions for technical challenges.
• Assist design transfer and product launch activities into manufacturing.
• Participate in continuous improvement initiatives to enhance product quality and manufacturing efficiency.

Requirements

• Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• Three to seven years of R&D experience in the medical device field.
• Experience with FDA Quality System Regulations and ISO 13485 design controls.
• Proficiency in CAD tools such as SolidWorks or an equivalent program.
• Strong practical engineering capabilities with hands-on troubleshooting and problem-solving skills.
• Excellent written and verbal communication abilities.

Technologies

• SolidWorks

Benefits

• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Why join our team

• Contribute to medical technologies that improve patient outcomes and make a difference in care.
• Direct engagement with customers and a meaningful influence on project results.
• Opportunity to work across all phases of product development.
• Growing organization where individual contributions have a substantial impact.
• Collaborative, entrepreneurial work environment.

Pay

Salary range: USD 80,000 to 105,000 per year.

Work Location

Minneapolis, MN, onsite (in person).