Sustaining Engineer II - Vascular Access Devices

FLEX Vascular; Plymouth (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

FLEX Vascular is seeking an Engineer II in Sustaining Engineering for vascular access devices. You will support design, development, validation, and sustaining engineering, while adhering to design controls and QMS requirements.

The role involves creating test methods, performing TMV/MSA, participating in risk management (DFMEA/uFMEA), and collaborating across engineering, QA, and manufacturing to ensure ongoing product reliability and process improvements.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or related engineering.
• 2–5 years in medical device or FDA-regulated environment.
• Experience with design controls and validation (IQ/OQ/PQ, TMV, MSA).
• Ability to author technical protocols and reports for regulated document systems.
• Proficiency with 3D CAD software and standard office tools.

Responsibilities

• Provide project support including device and component testing, protocol authoring, documentation of test results, data analysis, and technical reports.
• Contribute to Design History File (DHF) and Device Master Record (DMR).
• Design, model, and fabricate test and manufacturing fixtures, including CAD modeling and 3D printing of prototypes.
• Participate actively in design and process reviews.
• Design and execute TMV, MSA, and DOE studies; analyze results and report.
• Support IQ/OQ/PQ activities, protocol/report authoring, and testing.
• Develop sampling plans and acceptance criteria with statistical rationale.
• Participate in PFMEA/DFMEA and update risk management files.
• Interact with suppliers to support process transfers and changes.
• Inspect products and components per policies; assist in shipping/receiving.

Skills

SolidWorks

Design controls

DOE

MSA

3D printing

Education

Bachelor's degree in engineering

Tools

SolidWorks

MS Office

Job description

FLEX Vascular is seeking an Engineer II in Sustaining Engineering for vascular access devices. You will support design, development, validation, and sustaining engineering, while adhering to design controls and QMS requirements.

The role involves creating test methods, performing TMV/MSA, participating in risk management (DFMEA/uFMEA), and collaborating across engineering, QA, and manufacturing to ensure ongoing product reliability and process improvements.