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.

OUR VISION Empowered by movement, people with spinal cord injury will enjoy life in every way that matters to them. We are a team of scientists, engineers and physicians, collectively driven to create therapies that change lives. We understand the challenges of those living with spinal cord injury.

Formed in 2014 by researchers at the Swiss Federal Institute of Technology (EPFL), we are now headquartered in Eindhoven, the Netherlands with a Science and Engineering Center in Lausanne, Switzerland, and a growing presence in the US focused in Boston, Massachusetts.

Program Manager

Program Manager

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

About the job

About you

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