Senior Program Manager, Medical Device / Hardware
Other Engineering, Operations
San Carlos, CA, USA
Posted on Tuesday, February 6, 2024
Q Bio is building technology for the Physical of the Future that measures more, faster and cheaper about the human body, to enable proactive primary care for all. We're revolutionizing primary care with the first clinical digital twin platform, powered by breakthrough whole-body scanning technology, that highlights the most important changes in a person’s physiology for sharing with physicians and specialists anywhere in the world.
Q Bio’s clinical digital twin platform, Gemini, is the first to capture and monitor comprehensive baseline patient health in a scalable virtual model. The Gemini Dashboard highlights the most important chemical and anatomical changes in an individual weighted by an individual’s lifestyle, genetic and medical history, that can be securely shared with physicians and specialists all over the world.
Gemini is powered by the fastest, most accessible, whole body scanner developed: the Mark I. Self-driving and optimized for primary care, the Mark I can complete a whole-body scan in 15 minutes or less in an open space, without radiation, breath holds, or claustrophobia. Patient comfort is maximized with the option to sit, stand, or lie down, and real-time telemetry is displayed throughout.
Why should you consider a career with Q Bio?
We dream big. Our team is aligned and excited about the opportunity to save lives and understand the human body like never before. We know how critical empowering and supportive leadership is, both to our excellence as a company, and for our team experience as a whole, and our leadership team will empower and support career growth. We’re a team of engineers, scientists, and operators who come from a diverse background of disciplines and experiences. We value teamwork, growth, determination and persistence, commitment to collaboration, and a reliance on staying nimble while keeping the big picture in mind.
Q Bio is seeking a program manager with experience bringing new medical device products into the market. This program manager position will work with cross-functional teams inside Q Bio as well as external partners (vendors and contractors) to ensure timely progress on proof-of-concept generation, prototyping, integration, and verification and validation of a newly developed medical device. The ideal candidate will take expansive ownership of system development programs, including hardware, device software, imaging science, and from concept generation, prototyping to mass production and commercialization phases.
- Develop and manage the overall Mark I development program including scope definition, requirements, schedules and deliverables with cross-functional teams, vendors and partners
- Provide day-to-day coordination and progress tracking for projects and tasks, the go-to person for questions regarding program updates, internal specifications, and regulatory requirements
- Lead program planning, progress updates, and milestone review meetings and responsible for drafting meeting minutes and action items
- Report or coordinate reporting to the head of the Radiomics department on a daily basis, provide insights on making trade-offs, and collect feedback
- Provide routine program updates and communications to the management team
- Own the relationships with strategic external partners (vendors, contractors …)
- Communicate program updates clearly to stakeholders in a timely fashion to ensure the alignment between cross-functional teams and external partners in terms of latest requirements, timeline and deliverables
- Contribute to drafting and reviewing quality documentation for the Mark I project, and lead the efforts on optimizing the program workflow and procedure for improving efficiency and reliability
- Participate in internal regulatory discussions and meetings with FDA and contribute to the preparation of documentations for Mark I
- Proven communication skills
- BS or advanced degrees in mechanical engineering, electrical engineering, Biomedical engineering, or other relevant engineering discipline
- 5+ years experience as program manager managing hardware projects from concept to mass production
- Strong track record of managing complex highly technical cross-functional projects
- Excellent presentation skills with the ability to facilitate meetings and document processes
- Strong references that highlight your ability to build good working relationships with senior leaders and engineers across functions and departments
- An ability to keep the big picture in focus and to provide clear, well-structured, and concise communications for appropriate audiences
Preferred qualifications include:
- Demonstrated experience of managing technical projects bringing medical devices from concept generation through FDA 510(k) clearance
- Working knowledge of MRI physics and hardware system architectures
- Experience working in FDA regulated industrial environment and working knowledge of design control workflow
- Working knowledge of PLM, Quality, and Regulatory functions
- Working knowledge of Quality System standards and regulations including 21 CFR 820, ISO 13485, MDSAP
- Working knowledge of risk management and other standards including ISO 14971, IEC 60601, and IEC 62304
In the San Francisco Bay Area, the standard pay range for this role is $175,000-$200,000 annualized. This pay range is for the San Francisco Bay Area and is not applicable to locations outside of this location or for remote roles. Actual amounts will vary depending on experience, performance, and work location. In addition to a competitive base salary, we offer significant equity and an employee-friendly stock option plan. Employees will also be eligible to participate in benefits plans available to other similarly situated employees subject to any eligibility requirements imposed by such plans.
Q Bio was founded in 2015 by serial entrepreneur Jeffrey Kaditz, Dr. Michael Snyder, Chair of Genetics and Director of Personalized Medicine at Stanford University, and Dr. Garry Choy, physician, radiologist, and former Chief Medical Information Officer at Mass General Hospital. Q Bio has raised over $80M from world class investors including Andreessen Horowitz, Kaiser Foundation Hospitals, Khosla Ventures, Founders Fund, SciFi VC, and many more.
Q Bio is an Equal Opportunity Employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.