Job Description
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.
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