Department: Precision
Location: Santa Clara, California
Compensation: $200,000 - $225,000 / year
Description
Precision is building a direct connection between the human brain and computers, to benefit the hundreds of millions of people worldwide suffering from neurological conditions. Established in 2021, we are a leader in the development and commercialization of brain–computer interfaces (BCI).
As a Precision employee, you will be collaborating with experts across a diverse array of fields–including neurosurgery, mechanical engineering, machine learning, and microfabrication–to push the boundaries of what is possible. You will be joining a well capitalized and fast-moving company. In the two years since Precision's founding, we have built and validated a product and have begun human trials in partnership with some of the country's leading neurosurgery programs. And you will be working toward a deeply meaningful goal: restoring function to people living with devastating neurological conditions, including stroke, spinal cord injury, traumatic brain injury, and neurodegenerative disease such as ALS. Our platform will enable these individuals to regain independence, communicate with loved ones, and return to work.
We are seeking a highly experienced
Senior Manager / Director of Technical Program Management (TPM) to lead the TPM organization and drive our development programs. This role will be responsible for planning and executing deliverables for Precision's programs, establishing best practice dashboards and reporting tools, and ensuring effective communication across multidisciplinary teams and management. The ideal candidate will have extensive experience in medical device development, including navigating regulatory landscapes such as 510(k), DeNovo, and PMA, as well as driving product launches.
This position is on-site at our Santa Clara, California office. We are unable to consider fully remote workers or people not currently based in the United States, and who do not have working rights.
Key Responsibilities
- Lead and manage TPM in planning, coordinating and tracking deliverables across Precision's programs.
- Drive the execution of programs from concept through commercialization, ensuring all milestones, dependencies, and deliverables are met.
- Maintain timelines, budgets, and resources while adjusting plans as necessary based on project progress or risk mitigation.
- Develop tools and prepare reports to track deliverables and key performance indicators (KPIs), allowing regular updates to the leadership team on active company projects including those that you directly manage.
- Partner with cross-functional teams including strategic program management, hardware, software, electrophysiology, clinical, regulatory, and quality teams.
- Provide input into the development of overall program objectives, milestones, and KPIs.
- Build trust and foster effective working relationships with cross-functional peers in product, hardware, clinical, firmware, software, regulatory, and quality teams.
- Serve as a key point of contact for external R&D consultants and contractors, including manufacturing partners and suppliers.
- Collaborate with external partners to ensure alignment and adherence to the program's objectives, timelines, and quality requirements.
- Ensure compliance with FDA and global medical device regulatory standards, specifically under 21 CFR Part 820.
- Support verification and validation (V&V) activities, ensuring that the product meets regulatory requirements, including Class II and Class III medical devices.
- Drive process improvements to enhance project team productivity and overall quality.
- Hold team members, peers, and leadership accountable for meeting project objectives and timelines.
- Foster a culture of ownership, bias toward action, and urgency within the organization, ensuring rapid decision-making and execution.
Skills, Knowledge and Expertise
- Bachelor's degree in engineering, computer science or applied physics or a related field. An advanced degree is preferred.
- At least 7 years of experience as a Technical Program Manager, demonstrating increasing responsibilities including at least 2 years of supervisory management. For the Director role, at least 10 years of experience, with responsibilities including management of a department such as a program management office.
- Proven track record of driving complex cross-functional programs to product launch.
- Experience leading medical device projects through regulatory processes such as 510(k), DeNovo, or PMA.
- Experience with Class II and Class III medical device development under 21 CFR Part 820.
- Strong understanding of verification and validation (V&V) activities for hardware and software projects.
- Experience managing suppliers (both domestic and international) for hardware components and subassemblies (mechanical, electrical) and software development.
- Strong communication skills, with the ability to effectively convey complex ideas to technical and non-technical audiences
Preferred Qualifications:
- Prior experience in leading medical device development teams from R&D through to commercialization.
- Experience working with both internal stakeholders and external partners in a fast-paced, matrixed organization.
- Familiarity with agile methodologies and tools to manage projects effectively.
Diverse workforces create the best culture, company, and products. We at Precision are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Precision does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law
