R&D Manager

Vein360; Blue Ash (OH); On-site; USD 120,000 - 150,000; Full time

Job summary

Vein360 is seeking an experienced R&D Manager to lead a team of development engineers and project managers at our Cincinnati, OH facility. The role blends hands-on technical leadership with strategic influence over product development and regulatory submissions.

You will own the full lifecycle from concept through 510(k) submission, mentoring a high‑performing team while ensuring strict adherence to 21 CFR Part 820 and rigorous documentation practices. This is a full-time, on-site position.

Qualifications

• Bachelor's degree in Mechanical/Biomedical Engineering or related field.
• 7+ years in medical devices or related industry.
• Strong written and verbal communication; detail-oriented documentation.
• Experience with CAD tools (SolidWorks/Creo) and regulatory processes.

Responsibilities

• Lead and mentor engineers and project managers to deliver on-time product development.
• Own the 510(k) submission process from drafting through approval.
• Maintain Design History File documentation and ensure 21 CFR Part 820 compliance.
• Review and approve drawings, tests, and technical reports.
• Manage department budgets and resource planning.
• Drive cross-functional alignment with Operations, Quality, R&D, and Finance.
• Present updates to senior leadership and stakeholders.
• Develop vendor and contractor relationships to support development.
• Recruit, interview, and grow the team while enforcing a fair, professional culture.

Skills

Team Leadership

Regulatory Knowledge

Project Management

Documentation

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Creo

MS Office

Visio

Project

Job description

R&D Manager

Location: Cincinnati, OH (100% On-Site)

Vein360 is looking for an R&D Manager to lead a talented team of development engineers and project managers at the forefront of medical device restoration. Transforming previously used healthcare products into like-new, market-ready solutions. This is a rare opportunity to blend hands‑on technical leadership with strategic influence, shaping both the products we deliver and the people who build them.

This position is based full-time at our Cincinnati, OH facility. It is not eligible for remote or hybrid work.

Why This Role Matters

You'll own the full lifecycle of product development, from concept through regulatory submission, while mentoring a high‑performing engineering team. If you thrive at the intersection of technical rigor, regulatory expertise, and people leadership, this is your next challenge.

What You'll Do

• Lead and develop a team of engineers and project managers, driving successful, on‑time product delivery
• Own the 510(k) submission process from drafting through approval
• Maintain rigorous Design History File documentation and ensure full compliance with 21 CFR Part 820 and other applicable regulations
• Review and approve critical technical documentation, including drawings, test protocols, and reports
• Manage departmental budgets and resource allocation
• Stay ahead of evolving industry standards and regulatory requirements
• Drive alignment across cross‑functional teams - Operations, Quality, R&D, and Finance
• Present project updates and departmental progress directly to senior leadership
• Build strategic vendor and contractor relationships to support product and process development
• Recruit, interview, and grow your team as the department scales
• Champion a safe, inclusive, and collaborative team culture

What You Bring

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field (Master's preferred)
• 7+ years of experience in medical devices or a closely related industry
• Strong command of MS Office; familiarity with Visio and Project a plus
• Instructor-level proficiency in CAD software (SolidWorks, Creo, or similar) preferred
• Exceptional organizational skills and a sharp eye for documentation and detail
• Proven ability to write and implement advanced technical procedures
• A creative problem‑solver who thrives amidst change
• A confident communicator and self-starter who can lead, motivate, and, when needed, manage performance and disciplinary matters with fairness and professionalism

Why Join Vein360

You'll be part of a mission‑driven team working on sustainable, high‑impact medical technology with the autonomy to lead, the resources to innovate, and the visibility to make a real difference at the leadership table.

Working Conditions

Office environment with frequent sitting, walking, standing, kneeling, and occasional climbing. Lab and production environment, including proper use of appropriate PPE for handling used medical devices. Includes donning of smocks, foot covers, safety goggles, face shield, hair net, and latex free gloves for extended periods of time. Frequent use of hand‑eye coordination while using equipment and tools. Visual capacity including depth perception, color vision, and peripheral vision enabling operation of office machinery, laboratory equipment, production equipment, and tools. Light physical effort required by handling objects up to 30 pounds occasionally and up to 15 pounds frequently.

Equal Employment Opportunity Statement

Vein360 is an Equal Opportunity Employer. Employment decisions are based on business needs, job requirements, and individual qualifications. Vein360 does not discriminate on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law.

Vein360 is committed to providing reasonable accommodations to qualified individuals with disabilities in the application process and throughout employment, as required by applicable law.

Disclaimer

This job description and above statements are intended to describe the general nature and level of work performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, qualifications, or working conditions. Duties, responsibilities, and activities may change at any time, with or without notice, based on business needs.