R-D Engineer I - Exempt

This exciting opportunity is located in Plymouth, MN, a vibrant hub for innovation and technology. Join a team dedicated to advancing healthcare solutions and making a difference in patients' lives.

Must Have:

• Bachelor’s degree (minimum) in Engineering or Scientific discipline and 0-2 years of technical engineering experience
• Strong technical writing, analytical, and problem-solving skills
• Working knowledge of QMS requirements and document control processes

Nice to Have:

• 0-2 years of experience with testing and data analysis, creating test protocols and reports
• Engineering experience in medical device, regulated manufacturing, or related industry
• Experience supporting TMVs, PPAPs, IQ/OQ/PQ activities, or equipment validations
• Experience with validation activities, technical documentation, and regulated quality systems
• Familiarity with design verification, test methods, equipment qualification, or process validation
• Hands-on laboratory or manufacturing support experience

Position Overview:

This engineer will support the PTA and Procedural Support portfolio within our R&D Released Product Management (RPM) team in the Peripheral Vascular Health Operating Unit. The role involves execution of product and process development activities, technical documentation, validation efforts, and cross-functional collaboration. Ideal for an engineer eager and quick to learn, who enjoys hands-on technical work, and is motivated by contributing to projects and teams that directly impact patients.

Key Responsibilities:

• Support execution of technical strategies and deliverables for the PTA and Procedural Support portfolio within the R&D RPM group
• Execute and support test strategies, including development, coordination, and completion of testing activities
• Perform hands-on laboratory and product evaluation work to build technical understanding of products and associated therapies
• Develop understanding of product functionality through test methods (TM), technical documentation, and product evaluations
• Execute Test Method Validations (TMVs) in accordance with applicable procedures and regulatory requirements
• Support Production Part Approval Process (PPAP) activities and associated documentation requirements
• Route, review, and approve technical reports while ensuring compliance with Quality Management System (QMS) procedures and documentation standards
• Collaborate with Regulatory Affairs to understand submission strategies and support regulatory documentation needs
• Support cross-functional teams to ensure project timelines, compliance requirements, and operational objectives are achieved

Additional Responsibilities:

• Design, develop, analyze, troubleshoot, and provide technical skills during research and/or product development
• Design studies to investigate specific life science questions within the field of expertise
• May be involved in product research and development and/or clinical trials
• Translate research discoveries into usable and marketable products