DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.

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.