Product Manager - Upstream

ABOUT ORGANOX:

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP).  It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

Position Summary

OrganOx has an exciting career opportunity for a Product Manager, Upstream at our American headquarters in Madison, NJ. In this role you will oversee full lifecycle management for our existing product portfolio with primary focus on early-stage innovation, strategic planning, and foundational requirements for our next-generation, connected medical device portfolio. You will act as the ultimate voice of the customer, bridging the gap between clinical needs and technical development. This role focuses on the "front end" of innovation—identifying high-value clinical opportunities, building business cases, and defining product requirements before handing off to downstream teams for commercial launch.  You will report to the Global Director of Marketing.

Responsibilities

Under direction from the Director, Marketing the Product Manager, Upstream will be responsible for:

Strategic Roadmap & Portfolio Ownership

·       Own and define the 1.5-to-5-year global product roadmap for your assigned clinical portfolio, ensuring alignment with corporate growth targets.

·       Lead strategic portfolio prioritization exercises, balancing disruptive innovation with incremental product line extensions.

·       Monitor changing healthcare regulations, policies governing organ donation and use, global macroeconomic healthcare trends, clinical literature, reimbursement shifts, and competitive intelligence to pivot strategy proactively.

Advanced Market Research & Clinical Insights

·       Design and execute comprehensive global Voice of Customer (VOC) strategies, including advisory boards, primary and secondary research, and procedural observations.

·       Partner with Key Opinion Leaders (KOLs), medical advisory boards, and scientific communities to identify high-value unaddressed clinical needs.

·       Analyze international healthcare economics to integrate global pricing, reimbursement, and market-access requirements early in the product concept phase.

Business Development & Financial Accountability

·       Author rigorous, executive-level business cases complete with complex financial models, target pricing, net present value (NPV) analytics, and risk assessments.

·       Drive funding approval through corporate Stage-Gate governance reviews by defending market assumptions and return on investment (ROI) metrics.

·       Partner with head of business development to provide commercial due diligence for external partnership, licensing, or acquisition (BD&L) opportunities.

Cross-Functional Pipeline Leadership

·       Translate ambiguous clinical insights into precise, high-level Product Requirements Documents (PRDs) and system-level design inputs.

·       Represent the “commercial voice” in cross-functional core teams consisting of senior leaders from R&D, Clinical Affairs, Regulatory Affairs, Quality Engineering, and Operations.

·       Collaborate with regulatory teams to architect global submission strategies, identifying predicate devices and user-needs mapping for FDA (510k/PMA) and EU MDR compliance.

·       Ensure a seamless transition and hand-off to Downstream Product Management partners as the product approaches commercial launch readiness.

Required Qualifications and Experience

Education

·       Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, or a technical equivalent.

·       An MBA or advanced scientific degree (MD, PhD, MS) is preferred.

Experience

·       7+ years of experience in medical device product management, upstream marketing, or product strategy.

·       Demonstrated understanding of the U.S. and global transplantation ecosystems derived from working with OPOs, transplant centers, or medical device companies that serve this sector.

·       Proven history of leading cross-functional teams to successfully drive complex class II or class III hardware/software/consumable systems through early development phases.

Technical & Behavioral Skills

·       Clinical Literacy: Comfort speaking with specialized clinicians regarding anatomy, biology, pathophysiology and the role that medical devices serve to improve health.

·       Design Control Competence: Strong working knowledge of early-stage medical device design standards and controls under ISO and FDA regulations.

·       Data Analysis/Synthesis: Strong financial acumen, data modeling capability, and experience turning raw objective and subjective data sets into summarized strategic insights and decision making.

·       Influence & Adaptability: Elite cross-functional communication skills to align often conflicting internal and external stakeholder interests.

·       High Emotional Intelligence: Self-awareness, self-regulation, and awareness of others’ emotions to manage complex interactions across a broad range of stakeholders while still driving timelines and results.

·       Travel: Willingness to travel up to 30% globally for clinical site observations, conferences, and stakeholder interviews

A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate.

We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development.