Upstream Medical Device Product Manager, Strategy

OrganOx Limited; Alabama; On-site; USD 120,000 - 180,000; Full time

Job summary

OrganOx Limited, a pioneering organ-technology company, seeks a Product Manager, Upstream to own the global roadmap and lead early-stage opportunities for next-generation connected devices. You will bridge clinical needs and product development, shaping requirements before downstream handoff for launch.

Applicants should have 7+ years in medical device product management or upstream marketing, with experience in class II/III hardware/software systems, US and global transplantation ecosystems,

Qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, or a technical equivalent.
• MBA or advanced scientific degree (MD, PhD, MS) preferred.
• 7+ years in medical device product management, upstream marketing, or product strategy.
• Experience with US/global transplantation ecosystems and cross-functional teams.
• Leading complex class II/III hardware/software/consumable systems through early development.

Responsibilities

• Own 1.5- to 5-year global product roadmap for your assigned clinical portfolio.
• Lead strategic portfolio prioritization balancing disruptive innovation with extensions.
• Design and execute VOC strategies with advisory boards and researchers.
• Partner with KOLs, medical advisory boards, and scientific communities.
• Analyze international healthcare economics for pricing and market access early.
• Author rigorous business cases with financial models and ROI metrics.
• Drive funding approvals through Stage-Gate governance reviews.
• Collaborate with BD for external partnerships, licensing, or acquisitions.
• Translate clinical insights into PRDs and system-level design inputs.
• Represent the commercial voice in cross-functional core teams.
• Coordinate global submissions with regulatory for FDA and EU MDR.
• Ensure seamless hand-off to downstream Product Management.

Skills

Product management

Upstream marketing

Cross-functional leadership

Financial modeling

Regulatory awareness

FDA 510k/PMA

Data analysis

Stakeholder management

Clinical literacy

Travel readiness

Education

Bachelor in Biomedical Engineering

MBA or MS/PhD preferred

Job description

OrganOx Limited, a pioneering organ-technology company, seeks a Product Manager, Upstream to own the global roadmap and lead early-stage opportunities for next-generation connected devices. You will bridge clinical needs and product development, shaping requirements before downstream handoff for launch.

Applicants should have 7+ years in medical device product management or upstream marketing, with experience in class II/III hardware/software systems, US and global transplantation ecosystems,