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Responsibilities:

Overall:

As a Project Management Leader, you lead/manage all cross functional project teams to plan, execute and achieve company objectives from concept through commercial launch.
This role puts strong emphasis on agility, strategic thinking, complex problem-solving and ability to influence others to drive results and may include supervision of direct reports upon hire or future opportunities for role expansion
Develop and manage project plans to identify and complete milestones with accountability for successful completion of all project deliverables
Serve as the primary lead project manager for multiple devices and a console
Provide direction, guidance, and oversight to core teams to execute projects for multiple clinical studies and initiatives on schedule and within budget
Determine resources, track forecasts, and set priorities for projects
Manage project status and ensure escalation and appropriate communication internally to key senior leadership/stakeholders
Facilitate/Lead cross functional teams to anticipate and communicate risks and lead in the implementation of mitigation strategies throughout design, verification testing, and clinical trials
Provide mentoring and coaching to other project team members
Actively leads multiple Project Management Office (PMO) continuous improvement activities

Planning:

Develop detailed project plans to meet clinical and regulatory objectives based on cross-functional input and analysis
Collaborate and influence to gain core team buy-in and team ownership of the plannal input and analysis
Manage the cross-functional integrated project plan and drive the execution through cross-functional teams, building the global project timelines, ensuring milestones, goals, risk and budget are achieved
Determines and discerns requirements on larger scale projects to establish the project deliverables and manages changes to the project scope and schedule

Team Leadership:

Lead cross-functional core team meetings
Build the following within the team: meeting discipline (agenda, minutes, action items), problem solving culture and accountability
Partner with project leads, cross-functional groups, and functional managers to define/manage resource requirements to support project objectives
Identify forward looking risk and determine mitigation plans with core team

Communication and Reporting:

Maintain weekly status reports, including timelines and performance dashboards
Maintain efficient and effective communication, per communication plan development and execution, to provide clarity for roles and responsibilities and alignment with stakeholders
Serve as conduit between project/team members in all cross-functional groups (e.g. Clinical, Ops, Quality, R&D, Regulatory, etc.)

Qualifications:

Education & Experience:

Bachelor’s degree with a minimum of 10 years of previous related experience including medical device, pharmaceutical, and/or biotech. Master’s degree or equivalent with 9 years of previous related experience as listed above
Experience managing large cross-functional projects related to the development of medical devices involving both disposable devices and a console (system)
Experience leading cross-functional team meetings, management updates and internal development review meetings
Experience managing the development of medical devices through initial launch within the US and EU or a combination thereof. Working knowledge of Design Control requirements (US, EU)
Medical device development experience with Class II or III interventional cardiology catheters such as IVUS, OCT, cardiac ablation/diagnostic, PTA/PTCA catheters, stent delivery systems and robotically driven catheters and their associated consoles
Knowledge of clinical studies
Working within in a start-up environment (early or late stage)
Critical Chain Project Management Experience using the Pro Chain suite of software (Scheduler, Enterprise and Pipeline)
PMP Certification

Skills & Abilities:

Strong problem-solving and analytical skills.
Excellent communication skills, capable of explaining complex technical concepts in clear, simple terms.
A collaborative team player.
Self-driven, highly motivated, with a passion for learning new technologies.

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