Program Manager

Vor 3 Tagen

Lausanne, Schweiz GTX medical Vollzeit

At ONWARD we're looking for a Program Manager to join our team.

Full-time - Lausanne

**About the job**:
ONWARD is implementing the role of a Program Manager to lead one or more programs in the company’s Neuromodulation portfolio (implantable and external stimulators) towards a continuous delivery pipeline and release on demand for multiple clinical studies, CE mark and IDE approvals.

**Responsibilities**
- Support the definition of products, services and/or studies roadmap, developing the business case and managing the related benefits and threats.
- Lead the program implementing the products, services and/or studies solution, including software Apps, Hardware, Embedded Software, Infrastructure, cloud, and test automation.
- Create the program management plan, implementing a common development cadence and annual calendars for Program Increments (PIs).
- Create the project charter together with Project Sponsor and Program Management Team, formalizing the release purpose, objectives, MVP features, milestones and estimated budget.
- Develop and manage program teams, long-term goals, budgets and provide oversight to main project plans and activities.
- Lead programs in accordance with the business priorities, developing the project life cycle to support the strategic direction.
- Assist project prioritization and economic decision-making by facilitating releases resources estimation, capacity allocation and timelines.
- Lead the program events as Program Core Team, PI planning, System Demos, and periodic Scrum of Scrums synchronization, including critical activities performed by the Agile Teams.
- Coordinate program related activities with suppliers, procurement, legal, clinical, finances, sales, marketing, and other business units.
- Operate within a budget and timeline framework when analyzing the impact of project decisions.
- Drive relentless improvement via Inspect and Adapt workshops; assess the program agility level and help foster the use of system engineering and Built-In Quality practices.
- Manage program risks and dependencies. Listen and support teams in problem identification and decision-making, creating an environment of mutual influence.
- Report on progress to the company’s management team on a regular basis. Escalate and track impediments and provide input on resourcing to address critical bottlenecks.
- Coach teams in Lean-Agile practices with powerful questions rather than use authority and support the personal development of the teams.

**About you**:

- Minimum 2 years of proven experience in program management and 5 years in project management, with a demonstrated track record in delivering high-quality solutions to the Medical Device field or other regulated industry.
- BSc/BEng in an Engineering principle required with relevant project management certification (e.g., PMI, SAFe, SCRUM). Program Management, MBA and leadership education as a plus.
- Relevant industry experience in design processes, as well as verification and validation of medical devices.
- Excellent understanding of development in a regulated environment with a personal respect for the regulations and procedures.
- Solid understanding & experience of ISO 13485, ISO 21500 and Agile development.
- Experience in Medical Device/FDA Regulated Industry and compliance with IEC-60601 and ISO 14708.
- Good understanding of clinical trials, marketing, and market access activities required for certification and market introduction of a new medical device.
- Results-oriented, hands-on and thrive well in an innovative, fast-paced and performance driven organization.
- Ability to understand the market, needs, and disease state associated with the therapy and human factors engineering.
- Good understanding of System Risk Management and the principals of Design for Manufacturing, Assembly and Test.
- Ability to work in a matrixed and geographically diverse business environment.
- You embody our values: Empowered, Committed, Pragmatic, Innovative, Open, Trusting, Collaborative, Passionate.
- Do you want to join our team as our new Program Manager? Then we'd love to hear about you

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