Product Manager - Upstream

OrganOx•Madison, NJ

1d•Onsite

About The Position

OrganOx has an exciting career opportunity for a Product Manager, Upstream at our global headquarters in Oxford, UK. 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.

Requirements

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

Nice To Haves

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

Responsibilities

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.
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.
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.
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.