Senior R&D Engineer, Vascular Access Devices

FLEX Vascular; Plymouth (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

FLEX Vascular is seeking an Engineer III in Minnesota to lead design, development, and verification of vascular access devices. You will own DHF/DMR content, mentor junior engineers, and drive cross-functional reviews with clinicians to translate real-world needs into robust specifications for safe device performance.

Independent project management, expert SolidWorks modeling, and deep knowledge of design controls are essential as you guide testing, validation, and regulatory compliance efforts

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering.
• 5–8 years of engineering experience in medical devices or FDA-regulated manufacturing.
• Proficiency with SolidWorks, including assemblies, drawings, and GD&T.
• Strong knowledge of design controls and validation principles (IQ/OQ/PQ, TMV, MSA).

Responsibilities

• Lead device design, development, and testing activities with protocol authoring and data analysis.
• Own DHF/DMR content and review contributions from junior engineers.
• Design and fabricate fixtures and tooling, including 3D printing of prototypes.
• Lead design/process reviews and present technical rationale to cross-functional stakeholders.
• Develop and maintain product specifications translating clinician needs into requirements.

Skills

Design controls

Cross-functional leadership

Project management

Communication with clinicians

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

JMP

Job description

FLEX Vascular is seeking an Engineer III in Minnesota to lead design, development, and verification of vascular access devices. You will own DHF/DMR content, mentor junior engineers, and drive cross-functional reviews with clinicians to translate real-world needs into robust specifications for safe device performance.

Independent project management, expert SolidWorks modeling, and deep knowledge of design controls are essential as you guide testing, validation, and regulatory compliance efforts