Are you driven to getting things done? Can you juggle multiple projects, coordination across functional groups, diving into technical details as well as high-level prioritization, all without breaking a sweat?
23andMe is looking for a highly motivated Senior Technical Program Manager experienced with medical software who can champion and implement process improvements to support streamlined (fast-paced) engineering in a highly regulated environment.
Who we are
Since 2006, 23andMe’s mission has been to help people access, understand, and benefit from the human genome. We are a group of passionate individuals pushing the boundaries of what’s possible to help turn genetic insight into better health and personal understanding.
Our mantra on the Program Management team is “getting the right things done at the right time.”
What you’ll do
Play a significant role on initiatives to leverage modern technology and innovative ideas for streamlining the tools and processes that comprise our Quality Management System. (Think electronic DHF, integrated requirements and test management system, etc….a modern QMS)
Project manage cross-functionally (matrixed resourcing) those initiatives and others. Produce timelines / milestones; communicate status / progress. Keep things on track.
Review, assess, and approve medical software changes (from various development teams) in accordance with our SOPs and design control process to ensure regulatory and quality standards are met.
Drive the collaboration on quality documentation (e.g. change orders, quality plans, etc.) as needed.
Represent Engineering in quality reviews, internal and external audits (e.g. FDA, ISO).
What you’ll bring
Experience at companies at different stages from startup to established corporation. You bring a balanced approach and mindset; provide good judgement. You know how to operate in an environment with multiple releases in a week with a “quality at speed” perspective.
Years of experience managing projects developing medical device software (or software as a medical device).
You know how to operate projects in compliance with regulations and international standards (e.g. 21 CFR 820, IEC 62304, ISO 13485, ISO 14971).
Working knowledge of guidelines and best practices (e.g. TIR45) for meeting compliance requirements using AGILE practices.
Bachelor's degree in Biomedical, Business, Computer Science, Software Engineering or related area of study, or equivalent combination of education and experience
Ability to operate at a “program” level; can manage multiple projects in orchestrated manner.
Ability to coordinate across functional groups and organizational boundaries. You know how to build consensus among competing perspectives and can rally teams positively towards objectives.
Advanced interpersonal and communication skills. Proven ability to interact with individuals with diverse (technical / non-technical / regulatory / business) backgrounds. Able to communicate clearly and effectively (master at being succinct) whether with engineers or executives.
Proficiency in program / project management tools (e.g. Gantt charts, spreadsheets, presentations, etc.).
Proficiency in engineering management tools (e.g. JIRA).
Demonstrated skills in interacting in highly collaborative online environment (e.g. google docs / spreadsheets, group chat, etc.).
6+ years in program / project management or technical management roles delivering software products to market.
Self-motivated, reliable team-player with ability to thrive in a fast-paced, demanding, complex work environment.
Proven ability in all levels of project execution from articulating big picture perspective to “rolling up your sleeves” contribution where relevant. Track record of getting things done.
PMP / PgMP Certification (more important than the certification, you truly understand how to apply best practices effectively and pragmatically).
Training or past experience as Scrum Master.
Great if you were in a hands-on software development / test role early in your career.
23andMe, Inc. is the leading consumer genetics and research company. Our mission is to help people access, understand and benefit from the human genome. The company was named by MIT Technology Review to its “50 Smartest Companies, 2017” list, and named one of Fast Company’s “25 Brands That Matter Now, 2017”. 23andMe has millions of customers worldwide, with ~85 percent of customers consented to participate in research. 23andMe is located in Mountain View, CA. More information is available at www.23andMe.com.
At 23andMe we value a diverse, inclusive work force and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.
Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.
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