Engineer III - R & D Engineering (Medical 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

Position Summary - Engineer III (R & D Engineering)

The Engineer III leads the design, development, verification, and sustaining engineering of vascular access devices and their associated manufacturing processes. Working under limited supervision, the Engineer III independently plans and executes complex engineering projects — including device and fixture design, test method development, process and equipment qualification, and technical investigations — and owns the associated documentation in compliance with the Quality Management System and applicable regulatory requirements. The role exercises sound engineering judgment on ambiguous or novel technical problems, provides technical guidance to less experienced engineers and technicians, and leads cross‑functional design and process review activities. The Engineer III maintains a patient‑first mindset throughout the design process, engaging directly with physicians and other clinical stakeholders to translate real‑world clinical needs into clear, robust product specifications that support safe and effective device performance.

Essential Duties and Responsibilities

The duties below are representative of the work performed in this role. They are not intended to be an exhaustive list.

Design and Development

• Lead device and component design, development, and testing activities, including protocol authoring, test execution, data analysis, and technical report preparation in accordance with design control procedures.
• Own and maintain Design History File (DHF) and Device Master Record (DMR) content for assigned projects; review contributions from junior engineers for completeness and accuracy.
• Design, model (SolidWorks), and fabricate test and manufacturing fixtures, including CAD modeling and additive manufacturing (3D printing) of prototypes and tooling.
• Lead or actively participate in design and process reviews, presenting technical rationale and risk/benefit analysis to cross‑functional stakeholders.
• Develop, author, and maintain product specifications — including design inputs, design outputs, and engineering drawings — that accurately translate physician and clinical end‑user needs into clear, testable engineering requirements.
• Participate in physician interactions, including voice‑of‑customer sessions, product evaluations, and cadaver or bench labs, incorporating clinical feedback into device design with patient safety and usability as the top priority.

Test Method Development and Validation

• Plan, design, and execute test method validations (TMV), measurement systems analysis (MSA) including Gage R&R studies, and designs of experiments (DOE); interpret results and recommend engineering action.
• Lead equipment qualification activities including IQ — authoring protocols and reports, executing testing, and resolving deviations.
• Develop statistical rationale for sampling plans, sample sizes, acceptance criteria, and confidence/reliability targets, and review rationale developed by others.

Risk Management and Quality Systems

• Lead or contribute significantly to risk management activities including DFMEA and use‑related FMEA (uFMEA); author and maintain risk management file content in accordance with ISO 14971, ensuring patient safety and clinical risk are systematically identified, evaluated, and mitigated throughout the device lifecycle.
• Lead design characterization, specification development, and test method development activities.
• Author, assess, and approve engineering change orders (ECOs) and change control records, including impact and testing assessments.
• Lead technical investigations for nonconformances, CAPAs, and complaint investigations. Complaint reportability and regulatory decisions remain the responsibility of Quality Assurance and Regulatory Affairs.

Prototyping and Fabrication Equipment

• Fabricate prototypes, fixtures, and tooling using filament‑based (FDM) and resin‑based (SLA/DLP) 3D printers, including print setup, material selection, and post‑processing.
• Use basic hand and shop tools — including a band saw, belt sander, drill press, and similar equipment — to fabricate, cut, and finish prototypes and test fixtures.
• Follow all applicable safety procedures and use required personal protective equipment when operating 3D printers, shop equipment, and hand tools.

General

• Support Company initiatives as identified by management in support of the Quality Management System (QMS), Environmental Management System (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other applicable regulatory requirements, and Company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communication and collaboration with employees at all levels, as well as customers, contractors, and vendors.
• Perform other duties as assigned.

Qualifications

Required

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• Working knowledge of peripheral vascular anatomy, disease states, and procedures is important, given the direct impact of device design decisions on physician technique and patient outcomes.
• 5-8 years of engineering experience, preferably in medical device or another FDA‑regulated manufacturing environment.
• Demonstrated proficiency with 3D CAD software (SolidWorks required), including assemblies, drawings, GD&T, and tolerance stack‑up analysis.
• Strong working knowledge of design controls and validation principles (IQ/OQ/PQ, TMV, MSA) and demonstrated ability to lead validation activities independently.
• Demonstrated ability to author and review clear, complete technical protocols and reports suitable for a regulated document system.
• Experience contributing to and maintaining Design History File (DHF) content.

Preferred

• Master's degree in Mechanical or Biomedical Engineering.
• Familiarity with medical device standards and guidance documents (e.g., ISO 13485, ISO 14971, ISO 10555).
• Experience with statistical software (e.g J, JMP) and applied statistical methods.
• Experience with GD&T, inspection method development, and FEA.
• Experience with catheter, guidewire, or other vascular access device design and manufacturing processes.
• Prior experience mentoring or providing technical direction to junior engineers.
• Experience interacting directly with physicians or other clinical end users to gather feedback on device design, usability, and product specifications