Senior Hardware Program Manager

Owletcare; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

An innovative company is seeking a Senior Hardware Program Manager to lead hardware development initiatives that enhance parenting experiences. This role involves managing cross-functional teams, ensuring compliance with regulatory standards, and driving projects from concept to production. The ideal candidate will have over 10 years of experience in hardware development and program management, with a strong grasp of the medical device lifecycle. Join a forward-thinking team dedicated to creating impactful products that provide peace of mind to parents worldwide.

Qualifications

• 10+ years of program management experience in hardware development.
• Deep understanding of the hardware product lifecycle.
• Familiarity with FDA, ISO, and IEC standards.

Responsibilities

• Lead hardware development programs from concept to launch.
• Create and manage detailed program plans and budgets.
• Drive coordination across engineering, quality, and regulatory teams.

Skills

Program Management

Hardware Development

Regulatory Compliance

Cross-Functional Coordination

Communication Skills

Risk Management

Education

Bachelor's in Electrical Engineering

Bachelor's in Mechanical Engineering

Bachelor's in Biomedical Engineering

Tools

JIRA

PLM Systems (Arena, Agile)

Job description

Owlet is changing the world of parenting with meaningful products that truly make a difference for millions around the world. Owlet has helped more than a million parents keep their children safe, while bringing joy and sleep to the parenting journey. We believe every parent deserves the peace of mind that comes with a better understanding of their baby’s needs.

We are seeking a proactive, Senior Hardware Program Manager to lead the planning and execution of our hardware development efforts. You will be responsible for driving cross-functional initiatives spanning engineering, quality, operations, regulatory, and clinical teams, ensuring that product timelines, budgets, and requirements are met.

The ideal candidate has extensive background (10+ years) in hardware development, program management, and regulatory processes, with the ability to communicate effectively across technical and non-technical stakeholders.

Key Responsibilities:

• Lead hardware development programs from concept through design, prototyping, testing, manufacturing, and launch.
• Create and manage detailed program plans, schedules, budgets, risk assessments, and resource allocations.
• Collaborate closely with hardware manufacturers to ensure timely delivery, technical alignment, and quality assurance of physical components throughout the project lifecycle
• Drive resolution of technical, logistical, and compliance issues to keep programs on track.
• Ruthlessly mitigate risk to avoid negative impact to products, schedules and ensure highest possible quality releases
• Provide proper levels of communication to all stakeholders

Cross-Functional Coordination

• Drive coordination across teams—including electrical and mechanical engineering, industrial design, software, clinical, quality, and regulatory—and external partners to ensure aligned milestones, integrated workflows, and effective use of processes and tools (e.g., JIRA). Accountable to ensure all functions are working in sync toward program goals.

Regulatory & Quality Compliance

• Ensure hardware development processes align with ISO 13485, IEC 60601, and other relevant medical device standards.
• Support Design History File (DHF) and Device Master Record (DMR) documentation throughout the product lifecycle.
• Collaborate with regulatory affairs to support submissions (e.g., 510(k)) and audits.

Manufacturing & Supply Chain Integration

• Partner with Operations and Manufacturing Engineering to support DFM, DVT, EVT, and PVT milestones.
• Oversee hardware validation and verification activities in partnership with QA/RA and clinical stakeholders.
  
• Identify program risks and implement mitigation strategies early.
• Lead change control processes and document updates for hardware components and systems.

Qualifications:

Required:

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field is a plus
• 10 + years of program or project management experience in hardware development delivering highly complex initiatives that were time sensitive
• Experience in a regulated medical device or life sciences environment
• Deep understanding of the hardware product lifecycle, from concept to volume production
• Must be willing to travel, and internationally, to partners for manufacturing and other critical partnerships (e.g. CN, Vietnam, Thailand)
• Familiarity with FDA, ISO, and IEC standards for medical device
• Strong organizational skills and attention to detail
• Excellent communication and interpersonal skills

Preferred:

• PMP or equivalent certification
• Experience with wearable medical devices or diagnostic equipment
• Experience with PLM systems (e.g., Arena, Agile)
• Experience working with offshore manufacturing partner
• Experience in a regulated medical device or life sciences environment