Lead end-to-end program management for medical device development and sustenance, managing multiple concurrent projects.
Oversee technical execution across Digital Design, Component Engineering, Board Bring-up, and PCB Verification.
Manage program budgets, forecast resource needs, and optimize allocation across cross-functional teams (Electrical, Mechanical, Systems, Software, Quality).
Drive customer-facing activities including proposals, SOW preparation, delivery planning, and executive stakeholder communication.
Track project progress, proactively identify/mitigate risks, and report status to leadership and clients.
Utilize PLM, change management processes, and program tracking tools (MS Project, Jira, Asana, etc.) to ensure compliance and efficiency.
Orchestrate collaboration between internal engineering teams and external partners to deliver projects on time and within scope.
Qualifications
14+ years of professional experience, with a minimum of 3 years in Program Management.
5+ years of hands-on experience in medical device development or sustenance.
Strong technical foundation in Digital Design, Component Engineering, Board Bring-up, and PCB Verification.
Business level Japanese and English (written and verbal)
Proven ability to manage budgets, forecast talent needs, and execute multi-project planning under tight deadlines.
Experience with PLM systems, change management, and modern program management software.
Exceptional leadership, negotiation, and cross-functional communication skills.
Preferred: PMP/PgMP certification, Agile/Scrum experience in regulated environments, and familiarity with ISO 13485, IEC 60601, ISO 14971, and Medical QMS.