Program Manager (Medical Devices)

TL;DR

Program Manager (MedTech): Leading cross-functional projects for the innovation and development of electro-mechanical medical device systems with an accent on full lifecycle management from concept to launch. Focus on ensuring compliance with FDA/ISO standards, managing project timelines, and leading multidisciplinary teams.

Location: Hybrid (Pleasanton, CA). Site-based with 1-2 days at home allowed.

Salary: $150k - $170k

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Lead cross-functional project teams in support of Class I - III medical devices.
• Manage all project phases from concept development to product launch.
• Develop and maintain project plans, schedules, and budgets using Waterfall or Agile methodologies.
• Ensure project deliverables comply with internal procedures and regulatory standards.
• Deliver periodic status reports to local and global management.
• Identify and promote new project management concepts and initiatives within the organization.

Requirements

• BS in Engineering discipline (Systems, Biomedical, Electrical, or Mechanical Engineering).
• 7+ years’ experience in medical devices or other regulated industry.
• 5+ years in a project manager role and 3+ years managing a team of project managers.
• Thorough understanding of Medical Device Quality Management Systems (ISO 13485, 21 CFR 820, ISO 14971).
• Working knowledge of FDA and International Standards for capital equipment and disposables.
• Ability to travel domestically and internationally up to 20%.

Nice to have

• Experience with Microsoft Project, JIRA, or Antura.
• Experience leading projects through a structured phase-gate process.

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance.
• 401k plan with company match.
• Paid Time Off and Wellness initiatives.
• Parental and Caregiver Leave.
• Tuition Reimbursement.
• Commuter Benefits.