Medical Device Product Development Project Manager at Proton Intelligence Inc
Clayton VIC 3168, , Australia -
Full Time


Start Date

Immediate

Expiry Date

16 Nov, 25

Salary

0.0

Posted On

16 Aug, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Iec, Iso

Industry

Information Technology/IT

Description

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.

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 62366 (working knowledge acceptable).

How To Apply:

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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.
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