Hardware Operations Manager

About the role

You will own the end-to-end hardware technical lifecycle for our AI-driven musculoskeletal health platform, defining strategy from concept to commercial launch. This role requires you to lead cross-functional alignment between software engineering, product management, quality assurance, and manufacturing partners located in both the United States and Asia. You will be responsible for ensuring that new hardware products meet rigorous regulatory standards and integrate seamlessly with our software infrastructure. Your work will directly support the delivery of high-quality digital health solutions to our members while optimizing operational efficiency. You will manage complex program risks and drive process excellence across the hardware development lifecycle. This position is critical to advancing our mission of lowering healthcare costs through innovative, evidence-based care.

Key facts

What you'll do

Lead the execution of new hardware technical programs from initial concept validation through commercial launch and into sustaining phases, adhering to medical device regulatory standards.

Develop and maintain strategic and tactical roadmaps that synchronize hardware engineering, software platform integration, supply chain, and regulatory activities across US and Asian operations.

Implement and integrate software platforms with physical hardware products, working directly with software engineering and functional stakeholders to ensure compatibility and performance.

Establish and monitor key program metrics, risks, and milestone progress, providing clear status updates and insights to senior leadership for informed decision-making.

Drive cost optimization initiatives that preserve product quality and adherence to delivery timelines without sacrificing operational excellence.

Champion the adoption of best practices and continuous process improvements across hardware operations and program management functions.

Own the coordination and execution of cross-functional initiatives, ensuring alignment among engineering, product, quality, and manufacturing teams on a global scale.

Maintain strict compliance with medical device regulations and quality standards throughout the product lifecycle, including documentation and audit readiness.

Collaborate with data science and engineering teams to ensure that hardware infrastructure supports the scalability and reliability of AI and machine learning workflows.

Identify and mitigate operational bottlenecks, developing contingency plans to maintain momentum and on-time delivery.

Serve as the primary operational link between technical teams and leadership, translating complex hardware challenges into actionable strategies.

Oversee resource planning and allocation to optimize team capacity and meet aggressive product development timelines.

Ensure that all hardware solutions are scalable, maintainable, and aligned with the long-term digital health platform vision.

Promote a culture of accountability, transparency, and data-driven decision-making across the hardware operations organization.

Requirements

You must possess a minimum of 5 years of professional experience in hardware operations, technical program management, or a closely related discipline.

You must have at least 3 years of hands-on experience managing cross-functional projects in environments that combine hardware and software development.

You must have at least 3 years of experience implementing and integrating software platforms with hardware products, collaborating closely with software engineering teams.

You must hold a Bachelor's degree in engineering, supply chain, or another relevant technical field.

You must demonstrate a strong understanding of medical device development processes and quality management systems.

You must be proficient in planning and executing programs that involve stakeholders based in both the United States and Asia.

You must have the ability to analyze complex operational problems and devise practical, data-backed solutions.

You must communicate effectively in both written and verbal formats with technical and non-technical audiences.

You must have experience thriving in fast-paced, high-growth technology companies.

You must be comfortable navigating ambiguity and taking ownership of end-to-end program execution.

You must be detail-oriented and capable of managing multiple priorities simultaneously without sacrificing accuracy.

You must be committed to maintaining compliance with industry regulations and standards.

You must be willing to travel occasionally to support global team collaboration and stakeholder engagement.

Nice to have

A Master's degree in engineering, business, or a related discipline.

Direct experience working within the medical device or digital health industry.

Familiarity with regulatory frameworks such as FDA and ISO 13485 for hardware products.

Hands-on experience with Agile or Lean development methodologies in hardware environments.

A proven history of successfully delivering complex hardware products on schedule and within budget.

Demonstrated leadership in managing programs that involve distributed US and Asia-based teams.

Strong analytical capabilities and advanced problem-solving skills.

Exceptional verbal and written communication skills.

Experience in high-growth, dynamic, and rapidly evolving company settings.

Practical notes

This role is full-time and based in San Francisco, California.

Occasional travel may be required to support collaboration with international teams and stakeholders.

Candidates must be authorized to work in the United States without sponsorship for this position.

The company is an equal opportunity employer and welcomes diverse candidates.