BioIntelliSense is ushering in a new era of continuous health monitoring and clinical intelligence for Remote Patient Monitoring (RPM) and Screening (COVID-19/Infection). Our medical-grade Data-as-a-Service (DaaS) platform seamlessly captures multi-parameter vital signs, physiological biometrics and symptomatic events through an effortless patient experience. The FDA-cleared BioSticker™ and BioButton™ devices make remote monitoring and early detection simple. Through the platform’s advanced analytics, clinicians, patients, and employers will now have access to high-resolution patient trending and reporting to enable medical grade care at home, and medical grade screening in the office, school, or residence. For more information on how BioIntelliSense is redefining remote patient monitoring through medical-grade and cost-effective data services, please visit our website at
BioIntelliSense.com.
About the Role
The Project Manager/Senior Project Manager will lead and manage cross-functional teams to assure new Mobile–SW product development projects are delivered on-time, on-budget, with high-quality. The incumbent plays a critical role in the development and ownership of project scope, timeline, budget, requirements, and risks. Ideal candidates will be proven and experienced medical device professionals who are able to effectively plan and launch innovative technology solutions into a complex healthcare market. The position reports to the Director of NPI Program Management for Software, as an individual contributor who leads through exemplary character, technical competence, proactive drive for results, sound logic supported by data, and artful communications.
What You Will Be Doing
- Organize, align, and motivate all associated project resources to build continuous integration, continuous delivery (CI/CD) software release trains in support of new system-level product introductions
- Define project objectives, requirements, and assumptions necessary to structure a project or activity
- Develop and execute project plans and schedules, aligning project tactics with portfolio/program strategy
- Manage projects within established scope, schedule, and budget while meeting project management performance/quality standards
- Lead and facilitate effective project meetings, manage change and conflict, and develop resource planning estimates to manage project workload and productivity
- Identifies and escalates appropriate project risks for resolution
- Communicates project plans, health/status, and metrics to key stakeholders and executive management
What We Are Looking For
- Bachelor’s degree required in Engineering or related technical/scientific field
- Minimum 5 years’ experience in medical device engineering, product development, or program management.
- Deep knowledge of medical device regulations including 21 CFR 820, ISO 13485, IEC 62304, ISO 14971
- Experience with modern Software Design and Development Processes, Design Controls, Design Transfer, Product Change Controls, Risk Management, CAPA, etc. in high-reliability, safety-critical applications
- Ability to learn the business and build bridges between functions to advance company initiatives and priorities – must be an effective collaborator and exceptional communicator
- Holds self and colleagues to high standards; accepts responsibility and accountability for project success and associated key decisions
- Continuous learning, improvement and growth mindset, biased toward action and committed to a quality driven approach
- Advanced analytical skills: Demonstrated ability to troubleshoot complex problems and process/system issues
- Resourceful: ability to prioritize and manage multiple tasks amidst simultaneous workstreams
- Experience with Smartsheet, Asana, Wrike, Tempus, or other cloud-based project management tools
Preferred:
3+ years taking complex, software-driven, Class II or Class III medical devices and/or Software-as-Medical-Device (SaMD) solutions from concept through commercial launchExpert understanding of mobile (iOS, Android) embedded systems and wireless communications technologies/standards for Internet of Things (IoT) wearables, digital health, remote patient monitoring applicationsMaster’s degree in business administration (MBA) or advanced degree in a related technical/scientific fieldProject Management Professional (PMP) certificationExperience using Agile tools and methodologies to accelerate the delivery of high-quality software releases
$120,000 - $160,000 a year
Salary Expectations: Listed is total compensation and is based on experience and location
Work Location: Hybrid in CA or CO office or Remote
You're excited about this opportunity because you will:
Join a fast-growing company and grow right along with us
Work on challenging and interesting tech problems which reshape the future of healthcare
Get the chance to work on cutting-edge technologies
Make a large impact across the company through business deliverables and continuous innovation
Opportunity to build solutions and organizations
Why You'll Love Working at BioIntelliSense
We are leaders - Leadership is not limited to our management team. It's something everyone at BioIntelliSense embraces and embodies.
We are doers - We believe the only way to predict the future is to build it. Creating solutions that will lead BioIntelliSense and healthcare industry is what we do.
We are learning - We're not afraid to dig in and uncover the truth, even when it's inconvenient. Everyone here is continually learning on the job.
We have great benefits - Medical/Dental/Vision/Life, disability (STD & LTD), 401(k) auto contribution program, 11 paid holidays per year, generous paid time off and a weekly lunch perk.
BioIntelliSense is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran, disability status or any other status protected under federal, state or local law.
