Bolt Medical
Director of Project Management
Bolt Medical, Carlsbad, California, United States
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.