Owlet’s Healthcare Business is searching for an energetic and experienced Medical Device Project Manager to lead a cross-functional team in the development, clinical evaluation, and regulatory clearance of innovative medical devices in the maternal and baby care markets. The ideal candidate has extensive experience driving hardware and software medical device initiatives from inception through post-market monitoring with a focus on quality and a passion for driving products that will enrich lives.
- As a Project Manager you are
- Servant Leader - empowers the team to make decisions, improvements and use best practices
- Roadblock clearer - Resolves impediments/conflicts and escalates when needed
- Resource facilitator - Works cross-functionally to ensure resourcing is prioritized
- Process manager - helps the team define and refine best practices
- Coach/facilitator - Mentors cross-functional team members of effective report
- Communicator - Reports and communicates project progress
- You Will
- Own the delivery of medical device products against project schedules (mix of internally and externally resourced projects)
- Closely coordinate engineering teams with Regulatory/Quality teams, Compliance Labs, Notified Bodies, etc.
- Manage creation and maintenance of Design History File(s)
- Align with Clinical Program Managers, external CROs, and host sites to ensure timely execution of clinical trials
- Lead cross-functional teams leveraging Scrum methodologies and best practices
- Ruthlessly mitigate risk to avoid negative impact to products, schedules and ensure highest possible quality releases
- Provide proper levels of communication to all stakeholders
- Coordinate with product and operations teams to build out launch plans
REQUIRED SKILLS AND QUALIFICATIONS:
- Extensive experience delivering Class II (FDA) and Class IIa/b (EU) Medical devices (EU-MDR experience desired)
- Working knowledge of applicable medical device standards in key worldwide markets
- Experience managing external vendors – both as augmented resources as well as turn-key
- Experience managing supplier relationships during the product development life cycle
- 5+ years of Medical Device Program/Project Management experience
- 5+ years proven track record of leading engineering teams (SW & HW)
- Well versed and comfortable with Agile principles and Scrum/Kanban methodologies.
- Possesses advanced oral and written communication skills.
- Experience Validating Manufacturing Processes (IQ/OQ/PQ)
- An individual who subscribes to the idea of Servant Leadership being a core principle of their interactions with the teams they lead
- Facilitator - Encourages autonomy and authority within the team, supports the problem solvers to solve the problems and the decision makers to remove obstacles and support the solutions
- Collaborative - Isn’t selfish. Works across the organization to ensure the organization is successful and not just the individual
- Resolves conflicts - Skilled in breaking down barriers in teams to get things moving in the right direction
- Excellent communication skills - Program managers are facilitators, which means that they need to be able to listen as well as articulate issues amongst a diverse group and facilitate understanding and decision making whether it be for technical items or for executive-level discussions
- Organized - loves lists and plans; often has a plan for a plan and understands the importance of meeting commitments
- Inquisitive - Not afraid to ask questions to have a better understanding; likewise, a facilitator of inquisitiveness, supports the team in asking questions in order to arrive at the best solution
- Flex time scheduling
- Competitive compensation based on experience
- Benefits package
- Product discounts
Owlet Baby Care, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.