You are at the front lines of med tech innovation. You’ll join a top talent, fun, diverse, tight-knit team of experienced professionals who have worked in healthcare and technology across multiple functions. We think big and bold, and relentlessly execute.
You are central to our ability to execute on our mission to improve the health of moms and babies. You interact with all teams in Bloomlife, including the product, engineering, regulatory, and quality teams. You manage the technical execution of the product roadmap. You ensure cross-company alignment between product roadmap and project timelines. Your mission is to deliver thoughtful, well-executed products following our product roadmap, ensure alignment between product and engineering teams, and ensure the quality of release candidates throughout the development process. You master the project management triangle (scope, cost and time) and are creative in finding execution plans that maximize scope while minimizing cost and time.
Your responsibilities:
- You define overall project(s) planning aligned with the company strategy and objectives, in close collaboration with the Company founders, Head of Product and technical leadership
- You lead execution of critical project(s), and coordinate R&D teams to refine and prioritize work with the team leader, and manage dependencies. You identify potential project and product risks and develop mitigation strategies. Manage project timelines, budgets, and resources to ensure timely progress, providing regular status updates to stakeholders.
- You manage external suppliers and ensure they deliver on spec, on time and within budget
- You collaborate closely with the Head of Product to gain a thorough understanding of user workflows and needs and leverage this knowledge to act as deputy product owner within engineering teams, providing clear, actionable day-to-day guidance. Ensure cross-company alignment between product roadmap and project planning.
- You follow the Design Control process by translating product requirements into clear design inputs (System Requirement) and verifying that design outputs fully satisfy these requirements. You maintain traceability throughout the process to guarantee alignment with regulatory standards.
- You guide the team on medical device development best practices and maintain design history file in collaboration with the QA Manager
- You manage product releases during development, define acceptance criteria, run final tests, and own the release documentation process; You ensure end-to-end testing will confirm a quality product meeting user needs.
- You coach team on Agile practices and manage some of the Agile ceremonies
You’re a passionate and experienced medical device technical project manager with a track record of taking medical devices through the development cycle and to market. You are known for delivering high quality output under tight timelines. You have an eye for details and you will show it by adding a sentence on Ada Lovelace in your application.
You're praised for your ability to energize, unite and motivate teams to accomplish ambitious targets. You have outstanding listening and communication skills, and are able to identify issues in the team and the project before they become serious. You’re curious. You’re proud of the team achievements and products you've managed and how they change people’s lives.
To succeed in this role, you must have:
- 3+ year experience as technical project manager in medical devices or related field
- Experience with ISO 9001/13485 and risk management under ISO 14971
- Experience working within Agile teams
- Good communication and interpersonal skills
Additionally, it will help to have:
- Experience with software and hardware products
- Proven track record in getting medical devices through FDA or CE marking, and launching medical product
- Experience with software development under IEC 62304
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