FLEX VASCULAR
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FLEX VASCULAR
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We are dedicated and experienced professionals, driven by the mission of helping physicians more easily and effectively treat peripheral vascular disease. If you have a background that fits the positions we are looking for below, please reach out.
Current Openings
Why FLEX Vascular?
- Join a growing, agile scale-up Med Device organization where your ideas and contributions matter and no two days are the same.
- Gain broader exposure across physician engagement, marketing strategy, customer education, and commercial execution.
- Help build the future of vascular therapy while making a meaningful impact on patient care.
- Support renowned vascular physicians and KOL’s
- Leverage your program/project management experience to lead key event planning
FLEX Vascular is seeking a Clinical Marketing Manager to help shape how breakthrough vascular technologies are adopted, understood, and championed by physicians across the market. This highly visible role sits at the intersection of clinical innovation, physician engagement, and commercial execution.
The Clinical Marketing Manager will serve as a key partner to FLEX Vascular leadership, physician consultants, and key opinion leaders (KOLs), driving initiatives that elevate clinical understanding, support customer engagement, and accelerate market adoption. Our ideal candidate is passionate about building relationships, transforming clinical experiences into compelling customer stories, and coordinating programs that connect physicians, sales teams, and marketing initiatives.
This role offers a unique opportunity to work directly with industry-leading physicians, contribute to market-shaping strategies, and play a critical role in FLEX Vascular’s continued growth and innovation.
Key Responsibilities
Clinical Marketing & Content Strategy – 20%
- Lead development of compelling clinical marketing content/messaging that highlights physician experience, patient impact, and product differentiation.
- Own the FLEX Vascular Case Compendium, creating a library of clinical success stories, physician insights, and best practices for internal and external use.
- Partner with Sales Training, Marketing, and Product teams to develop messaging for educational tools, presentations, and customer-facing materials.
- Translate complex clinical information into clear, engaging messaging.
Strategic Marketing Support – 20%
- Gather physician, customer, and market insights to inform commercial strategy and product positioning.
- Monitor competitive activity and emerging market trends and provide recommendations to leadership.
- Partner cross-functionally with Marketing, Sales, Clinical, and Executive Leadership teams to advance key business initiatives.
- Develop reports and dashboards that measure program effectiveness and support data-driven decision making.
- Contribute ideas and content that strengthen FLEX Vascular’s brand presence and clinical credibility and messaging.
- Support project management activities and ensure timely execution of key marketing initiatives.
Physician & KOL Engagement – 40%
- Serve as the primary coordinator and relationship manager for physician consultants and KOL partnerships.
- Build strong relationships with leading physicians to support educational, advisory, and promotional initiatives.
- Coordinate KOL participation in conferences, speaker programs, advisory boards, and strategic company initiatives.
- Manage consulting agreements, engagement tracking, and related program administration.
Conference & Event Leadership – 20%
- Lead planning and execution of major industry conferences, physician education programs, and advisory board meetings.
- Coordinate speaker activities, presentations, logistics, and follow-up actions to maximize program impact.
- Manage budgets and resources associated with physician engagement and conference activities.
What Will Make You Successful
- 5+ years of experience in Clinical Marketing, Product Marketing, Medical Device Marketing, Clinical Education, Physician Programs, or related healthcare commercial roles.
- Strong communication, presentation, and relationship-building skills.
- Ability to translate clinical information into compelling yet simplified messaging.
- Demonstrated success managing multiple projects, stakeholders, and priorities simultaneously.
- Strong business acumen with the ability to identify opportunities and drive execution.
- Self-starter who thrives in a fast-paced, entrepreneurial environment.
- High attention to detail and commitment to excellence.
- Experience working directly with physicians, healthcare providers, or key opinion leaders, preferred.
- Familiarity with healthcare compliance requirements
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.
Position Summary
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., Minitab, 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.
Responsibilities
The KEMIC Therapy Specialist is a clinical-commercial role responsible for driving adoption, utilization, and clinical excellence of FLEX Vessel Prep Device with KEMIC technology across an assigned geography. This position blends hands-on clinical support with therapy development and sales execution, partnering closely with Business Development Managers (BDMs), physicians, and cross-functional teams to accelerate growth and improve patient outcomes.
- Drive therapy adoption and growth by executing regional plans to meet or exceed quarterly and annual sales and utilization targets.
- Provide hands-on clinical and procedural support in CCL, IR, and OR environments to ensure optimal technique and outcomes.
- Lead physician and staff education through in-services and formal training on indications, workflow integration, and best practices.
- Drive and support VAC submission and execution within Strategic aligned accounts
- Build and maintain strong relationships with physicians, administrators, and clinical stakeholders to support therapy conversion.
- Collaborate cross-functionally with Sales Team, Marketing, Medical Education, and Customer Service teams to support launches and growth initiatives.
- Ensure full compliance with regulatory, quality, and ethical standards while delivering market and competitive feedback.
We’re currently looking for individuals in the following regions: Northeast, Mid South / Gulf Coast & Las Vegas.
Qualifications
- 4 Year Bachelor’s degree.
- 2–3 years of interventional vascular clinical representative experience or 5+ years as a certified Vascular Radiology Technologist.
- Experience supporting procedures in CCL, IR, and/or OR settings.
- Strong clinical aptitude combined with a results-driven, growth mindset.
- Excellent communication, presentation, and relationship-building skills.
- Ability to travel extensively within assigned geography.
Position Summary
The Field Reimbursement Manager (FRM) is a field-based specialist who supports accurate coding, billing, and payer contract navigation for Flex Vascular products. The FRM travels to hospital, ASC, and physician-office accounts to educate billing and coding staff, troubleshoot claim and coverage issues, and help customers work through payer contract questions and updates. The FRM will also assist in on-boarding the patient access program and address patient access issues when they arise. This is a reimbursement education and support role.
Ideally, this candidate should be located in the Twin Cities area, but open to location as long as able to travel extensively via car and air.
Key Responsibilities
Field Support & Account Education
- Travel to target accounts (hospitals, ASCs, physician offices) to support correct utilization, coding, and billing of Flex Vascular products.
Payer & Contract Navigation
- Support and educate customers on how to work through payer contract issues, coverage policy updates, and prior authorization or documentation requirements. Track payer policy changes relevant to Flex Vascular products and communicate practical, account-level.
Onboarding to Patient Access Program
- Account activation and readiness: assess each account’s stage – discovery, readiness, activation, or optimization – and tailor support to the customer’s workflow, payer mix, resources, and reimbursement confidence.
Internal Coordination
- Partner with Sales, Market Access, Marketing, and Regulatory/Quality (RA/QA) to ensure all reimbursement education materials and communications are accurate, compliant, and non-promotional.
Training & Compliance
- Stay current on Medicare, Medicaid, and commercial payer policies affecting Flex Vascular products.
Qualifications
Required
- Bachelor’s degree or equivalent experience in a relevant field (business, health sciences, or related).
- 5+ years in a client-facing reimbursement or field support role (e.g., medical device reimbursement, coding/billing, market access, or related field-based healthcare role), with demonstrated skill in payer navigation (benefit verification, prior authorization, appeals, and coverage policy interpretation) and direct provider/practice support (on-site education, troubleshooting claims, and guiding staff through coding and billing questions).
- Working knowledge of Medicare Part A/B, Medicaid, and commercial payer reimbursement structures for medical devices/procedures.
- Familiarity with HCPCS/CPT coding conventions and claims processes; ability to learn Flex Vascular’s specific product codes (e.g., C1600) quickly.
- Strong communication and relationship-building skills with clinical, billing, and administrative staff.
- Ability to travel extensively (60–80%) within an assigned territory.
- Valid driver’s license and ability to travel by car and air as required.
Position Summary
The Shipping Clerk is responsible for the day-to-day fulfillment of customer orders, from receipt of the purchase order through order entry, packing, shipment, and invoicing. The position serves as the primary operational point of contact for order status and tracking inquiries from customers and the field sales organization, coordinates carrier pickups, and administers the movement of trunk stock and demonstration equipment between the facility and field representatives. The Shipping Clerk also maintains the shipping area and its consumable supplies so that outbound operations run without interruption.
Because the products shipped are medical devices, all work is performed in accordance with the Quality Management System and applicable distribution, traceability, and product-handling requirements.
This role will be at FLEX Vascular’s Corporate Headquarters in Plymouth, MN.
Essential Duties and Responsibilities
- Receive and process incoming purchase orders.
- Create sales orders.
- Pack and ship orders.
- Create and send invoices to customers.
- Schedule courier pickups.
- Provide tracking and order information to customers and sales representatives.
- Process trunk stock distributions and requests, including inventory transfers and the shipment of trunk equipment and demonstration units.
- Manage shipping equipment stock, including labels, packing paper, packaging, and related supplies.
Qualifications
- High school diploma or equivalent.
- 0–2 years of experience in shipping, order fulfillment, customer service, or warehouse operations.
- Working proficiency with an ERP or order management system and with Microsoft Office, particularly Excel and Outlook.
- Experience preparing shipments through common carrier platforms.
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