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Position Summary:
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:
Program Leadership & Execution
- 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.
Risk & Change Management
- 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