FLEX VASCULAR
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FLEX VASCULAR
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OUR TEAM
Careers
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
Summary (Scope of Job)
The Clinical and Med Affairs Manager bridges the gap between clinical and commercialization needs of FLEX Vascular with responsibility of leading, coordinating, and executing vital activities with the FLEX Vascular CMO, physician consultants and KOLs (Key Opinion Leaders). This role acts as a key point of contact with internal FLEX Vascular Leadership (including CMO) and Stakeholders and externally to physician partners and KOLs to maintain orderly communication and execution of key initiatives related to FLEX. Initiatives touched include clinical programs/studies, conference/symposium planning, and FLEX case study collection.
New Duties
Create processes to optimize:
- Coordination of KOL activities and time for FLEX Vascular project / program needs and development.
- Enhance communication internally and externally on related KOL activities and projects.
- Partner with FV Chief Medical Officer on organizational cross-functional activities and follow up with actions.
- Coordinate how to engage Medical/Clinical Affairs early for key Project and Leadership needs.
- Review KOL contracting: Keep contracts current and be front line of review of time ahead of compensation payments for consulting time.
- Front line owner for MAB events and program coordination and pull-through (cross functionally with FV Leadership).
- Manage the budget and resources for KOL support at conferences and MAB events, ensuring efficient and effective use of resources.
- Coordinate conferences, meetings, and site visits with KOLs / physician consultants.
- Develop and present reports on KOL and MAB program performance to senior leadership, providing insights and recommendations for future initiatives.
- Own development and execution of FLEX Vascular case compendium for both internal (in partnership with Sales Training) and external promotional use.
- Support cross-functional team members, providing guidance and feedback to help advance company-wide projects.
- FV Conference attendance and execution — own fine tuning of the biweekly conference planning call deck.
- Stay informed on competitor activity and market trends in discussions with KOL and physician partners, making recommendations for differentiation and competitive advantage.
- Ensure compliance with all regulatory and legal requirements in all marketing materials and communications.
- Foster a collaborative and positive work environment, promoting teamwork and communication within the marketing team and across departments.
Duties That Will Continue
- Effectively manage and develop key communication channels including company website, email campaigns, and the company’s social media posts.
- Thought partnership in new and revised content / collateral development and updates.
- Project management status reporting.
What’s Needed to Be Successful
- 5+ years of experience.
- Attention to detail.
- Willingness to learn and adapt to clinical knowledge and needs.
- Understanding and experience in clinical messaging development.
- Influence management skills.
- Understanding of Sunshine Act laws and FLEX Vascular consulting agreements with physicians.
- Ability to work independently and with cross-functional stakeholders to analyze and synthesize complex data (both internal and from customers) to make recommendations and pull-through tactics on key marketing initiatives.
- Demonstrated experience in developing and executing successful project management objectives, with a track record of achieving measurable results.
Medical Device Product Development & Manufacturing 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 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 issues 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.
Engineer III – Senior Product Development Engineer (Medical Devices)
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.
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