Engineering Program Manager

About the Role

We are looking for a hands-on Program Manager to lead the development of next-generation medical wearable devices from concept through market launch. In a fast-moving start-up environment, you will drive programs that combine electronics hardware, embedded software, and scalable manufacturing. This role requires both strategic oversight and a willingness to roll up your sleeves—bridging engineering, manufacturing, and regulatory disciplines to deliver innovative and compliant products on time and on budget.

Key Responsibilities

Program Leadership & Strategy

• Define the overall program roadmap and success metrics, balancing hardware, software, and manufacturing readiness.
• Drive program planning, budgeting, and resource allocation with a strong focus on speed to market without compromising quality or regulatory compliance.
• Serve as the primary liaison among engineering, manufacturing, regulatory, and business stakeholders.
• Manage external consulting firms in driving goals, deliverables, and timeline in meeting specific product engineering and marketing milestones.

Project Management

• Create and maintain detailed project plans, including engineering development, design transfer, and pilot production schedules.
• Identify and mitigate technical and manufacturing risks early; adjust plans to meet evolving start-up priorities.
• Champion lean program management practices and foster a culture of rapid iteration.

Manufacturing & Operations

• Collaborate with internal and external manufacturing partners (CMs, OEMs) to establish scalable, cost-effective production processes.
• Guide design for manufacturability (DFM) and design for testability (DFT) efforts from early concept through ramp-up.
• Oversee transfer from prototype builds to pilot production, ensuring smooth scale-up to full manufacturing.
• Work with supply chain teams to secure critical components and manage vendor relationships.

Cross-Functional Collaboration

• Coordinate hardware engineering, firmware/software development, industrial design, and clinical/quality teams.
• Facilitate quick decision-making and alignment between development and manufacturing.
• Lead cross-disciplinary problem solving to address both technical and production challenges.

Regulatory & Quality Compliance

• Ensure all design and manufacturing activities comply with applicable medical device regulations and quality standards (e.g., FDA, ISO 13485, IEC
• Support creation and maintenance of Design History Files (DHF) and manufacturing documentation.
• Partner with Quality and Regulatory teams to prepare for audits and product approvals.

Stakeholder & Executive Reporting

• Provide clear, concise updates to founders, investors, and leadership on program progress, financials, and key risks.
• Highlight manufacturing readiness and production milestones as part of overall program reporting.

Key Performance Indicators (KPIs)

• On-time delivery of program milestones (engineering, regulatory, and manufacturing).
• Successful design transfer and pilot production yields.
• Budget adherence and efficient resource utilization.
• Achievement of regulatory clearance and product launch targets.

Qualifications

Education & Experience

• Bachelor's or Master's degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or related field.
• 5–8 years of experience in program or project management within medical devices, wearable electronics, or high-tech hardware/software start-ups.
• Strong background in electronics hardware and embedded software/firmware development, with proven exposure to manufacturing operations.

Technical & Regulatory Knowledge

• Experience driving new product introduction (NPI) and scaling manufacturing from prototypes to volume production.
• Familiarity with medical device design controls and regulatory standards (FDA 21 CFR Part 11, ISO 13485, IEC 60601, IEC
• Understanding of low-power electronics, sensors, wireless communications (e.g., Bluetooth, Wi-Fi), and mobile app integration is a plus.

Skills & Competencies

• Entrepreneurial mindset with ability to thrive in ambiguity and rapidly changing priorities.
• Excellent leadership, communication, and organizational skills.
• Strong analytical and problem-solving abilities, including risk management in both engineering and manufacturing.
• Proficiency with project management tools (e.g., Jira, MS Project, or similar).

Preferred Certifications

• PMP (Project Management Professional) or equivalent project management certification.
• Certified ScrumMaster (CSM) or Agile project experience.

What We Offer

• The chance to shape and launch life-changing medical wearable technologies from the ground up.
• A collaborative, fast-paced start-up culture with significant ownership and growth potential.
• Competitive compensation package, including equity opportunities and comprehensive benefits.

Job Type: Full-time

Pay: $100, $150,000.00 per year

Benefits:

• Dental insurance
• Employee stock ownership plan
• Health insurance
• Paid jury duty
• Paid time off
• Vision insurance

Work Location: Remote