Senior Project Manager – Medical Devices
San Diego, California
Expiry Date :
Wed, 07 Jul 2021 23:59:59 GMT
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You will help teams define, track and ultimately achieve the objectives and goals required for FDA submissions. You will be responsible for ensuring the timely development and successful implementation of best practices in cross functional team leadership. Working with senior management, you will help develop and implement resource plans for current and future products.
* Overall responsibility to develop and implement the project management processes, coordinate with stakeholders to define, prioritize and track project resources
* Work closely with product development, R&D scientists, clinical and laboratory operations via processes to optimize the efficiency and to drive successful project execution.
* Lead cross-functional and technical teams to plan and execute multiple projects and initiatives
* Create and monitor overall project schedules, issues, risks and timelines
* Prepare, maintain, and present monthly project updates, action plans and status reports for core team and senior management.
* Maintain QMS and documentation for audits
* Maintain a high standard of product quality in compliance with FDA criteria
* Demonstrated successful leadership of a PM team/function with successful track record of delivering projects on time with quality.
* Experience building and/or improving PM capability for an organization. Natural knack for detail orientation and creating highly organized and efficient processes/systems.
* Model our core values: visionary; pioneering; truth seeking; driven; honest and considerate communication; embraces diversity. You are experienced as someone who exemplifies our culture, and you operate with transparency and integrity.
* MS/BS in biology or chemistry or related engineering fields with 8+ years of related project management experience within the medical device industry.
* Project Management Professional (PMP) Certification (or similar) and Product Development Project Management experience from prior medical device company/industry (or similar).
* Experienced with FDA-cleared product development
* Experience in Quality System Regulations (QSR) 21 CFR 820 and Design Control: ISO 13485:2003
* Prior experience setting up processes/systems from scratch.
* Strong presentation, communication, and facilitation skills.
* Once a month day trips between our San Mateo and San Diego offices.
Come join us in addressing large healthcare needs through precision epigenomic medicine!
Founded out of the Stanford laboratory of Steve Quake, Bluestar Genomics is reinventing non-invasive diagnostic testing using epigenomic technologies and next generation sequencing. Our liquid biopsy technologies provide the earliest possible measure of cancer biology without biopsy, enabling improved clinical and health system outcomes through simple and convenient blood testing. We are passionate and dedicated to discovering and developing clinical applications that will make significant differences in cancer and other large healthcare needs.
We are passionate and dedicated to discovering and developing medicines that will make a significant difference in cancer and other epigenomic-driven diseases. Our technologies provide novel insight and quantitation of human health and disease, with our focus on precision medicine applications improving both clinical and health system outcomes.
We provide generous benefits to all employees, including stock options and a fully-stocked kitchen! We value your physical presence in our office in building our cohesive team. We look for extraordinary lifelong learners with a passion and growth mindset for these areas, and for combining biological ingenuity with AI and data analysis. Led by a team with extensive experience bringing products from concept to market, we are an equal opportunity employer and value diversity at our company. We are building a world-class company, based in San Diego and San Mateo.