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Medical Device Product Development Project Manager

2 weeks ago

Clayton South, Victoria, Australia Proton Intelligence Inc. Full time US$125,000 - US$175,000 per year

Why Proton

We're building the world's first Continuous Potassium Monitor (CKM) to transform care for chronic kidney disease (CKD) and heart‑failure patients. The work is multidisciplinary — chemistry, hardware, algorithms, app/cloud software, and clinical validation— executed closely with our Melbourne lab and global colleagues. This role owns the project management "glue" that gets real devices and clinical studies over the finish line.

Scope

Own cross‑functional project management across sensor, substrate manufacturing, mechanical, electronics, integrated software, application software, and clinical study workstreams. Primary interface to QA/RA and Systems Engineering for design traceability; close partnership with Head of Medical & Clinical and VP Ops.

Ideal background
  • 8–12 yrs Medtech or medical diagnostics experience.
  • Has run multi‑team programs from R&D through V&V, design transfer, and early commercialization.
Non‑negotiables
  • Self‑starter: Proactively collects inputs and assembles coherent plans in a collaborative, collegial manner.
  • Systems mindset: Decomposes company goals into integrated hardware + software + clinical milestones with dependencies, critical path, and risk burn‑down.
  • Accountability operator: Establishes a single-source-of-truth plan (Jira, MS Project, Smartsheet, or similar) and runs weekly check‑ins.
  • Regulated‑product awareness: Familiar with ISO 13485 and FDA GMP. Comfortable with design controls and traceability (DHF, risk register, verification/validation planning); knows what audit‑ready means.
  • Vendor & budget control: Manages vendors/CMOs, POs, and a phase‑based budget with forecast vs. actuals.
  • Tool fluency: PM platform (Jira/MS Project/Smartsheet or equivalent), Google Workspace, Gantts via the PM tool, issue templates, risk and decision logs.
  • Time‑zone pragmatist: Comfortable coordinating across Canada, Australia, and the US.
  • Calm under change: Re‑baselines plans without chaos; makes tradeoffs explicit.
  • Collaborative: Works in a balanced, collaborative model with Technical Leads; no command‑and‑control and no order‑taking.
Core responsibilities
  • Project plan + critical path ownership across sensor, hardware, application software, and clinical timelines.
  • Phase‑gate hygiene: Establish and maintain phase-gated execution plan with clear exit deliverables. Convene and document design/phase-exit reviews in the DHF.
  • Project risk management: Identify project risks and drive mitigation plans; track burn‑down.
  • Communication cadences: Weekly cross‑functional, bi‑weekly executive readout, monthly budget vs. plan.
  • Decision framing: Create RACI, outline alternatives, costs, and the "what it buys us" rationale.
  • Metrics: Milestone hit rate, burn‑down, budget variance, readiness checklists.
Skills & signals we'll look for
  • A real integrated schedule you authored (hardware/firmware/app) showing dependencies and a risked critical path.
  • Examples of quantified tradeoffs (scope/time/quality) with clear recommendations.
  • A sample risk register you built (anonymized is fine).
  • Proficiency in a well-known project management platform (workflows/Gantt chart, components/WBS, boards, automations/alerts, and portfolio/roadmap views).
  • A concrete example of re‑baselining mid‑program.
  • Regulatory familiarity: 21 CFR 820.30, ISO 13485, ISO 14971, IEC 62304, IEC working knowledge acceptable).