Engineer II - Sustaining Engineer - Med Device

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

ENGINEER II - Sustaining Engineering (Vascular Access Devices)

Position Summary

The Engineer II role supports the design, development, validation, and sustaining engineering of vascular access devices and their associated manufacturing processes. Working within established procedures and under general supervision, the Engineer role II independently executes defined engineering projects — including test method development, process and equipment qualification, fixture design, and technical investigations — and documents the results in compliance with the Quality Management System and applicable regulatory requirements. The role escalates novel or ambiguous technical problems to senior engineering staff and contributes to cross-functional design and process review activities.

Essential Duties and Responsibilities

Design and Development Support

• Provide project support including device and component testing, protocol authoring, documentation of test results, data analysis, and preparation of technical reports in accordance with design control procedures.
• Contribute to Design History File (DHF) and Device Master Record (DMR) content for assigned projects.
• Design, model, and fabricate test and manufacturing fixtures, including CAD modeling and additive manufacturing (3D printing) of prototypes.
• Participate actively in design and process reviews.

Test Method and Process Validation

• Design and execute test method validations (TMV), measurement systems analysis (MSA) including Gage R&R studies, and designs of experiments (DOE); analyze and report results.
• Support line validation and qualification activities including IQ, OQ, and PQ — authoring protocols and reports and executing testing.
• Develop and document statistical rationale for sampling plans, sample sizes, acceptance criteria, and confidence/reliability targets.

Risk Management and Quality Systems

• Participate in risk management activities including PFMEA, DFMEA, and use-related FMEA (uFMEA), and contribute to the risk management file in accordance with ISO 14971.
• Perform process mapping and support process characterization and improvement initiatives.
• Author and assess engineering change orders (ECOs) and change control records, including impact and validation assessments.
• Provide technical investigation support for nonconformances, CAPAs, and complaint investigations. Complaint reportability and regulatory decisions remain the responsibility of Quality Assurance and Regulatory Affairs.

Manufacturing and Supplier Support

• Interact with suppliers and vendors to facilitate new manufacturing processes or changes to existing processes, including technical support during process transfers.
• Perform product and component inspections in compliance with company policies and procedures.
• Support shipping and receiving of commercial product and components as required.

Qualifications

Required

• Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or a related engineering discipline.
• 2-5 years of engineering experience, preferably in medical device or another FDA-regulated manufacturing environment.
• Working knowledge of design controls and validation principles (IQ/OQ/PQ, TMV, MSA).
• Demonstrated ability to author clear technical protocols and reports suitable for a regulated document system.
• Proficiency with 3D CAD software (e.g., SolidWorks) and standard office productivity tools.

Preferred

• Familiarity with medical device standards and guidance documents.
• Experience with statistical software (e.g., Minitab, JMP) and applied statistical methods.
• Experience with GD&T and inspection method development.
• Experience with catheter, guidewire, or other vascular access device manufacturing processes.
• Experience working in an ISO Class 7/8 controlled environment.