Some opportunities happen only once in a lifetime – like choosing a position where you have the chance to change lives. BiVACOR is a preclinical stage medical device company developing the BiVACOR Total Artificial Heart (TAH), the first long-term therapy for patients with severe heart failure. We're a team of hard-working, high performing specialists looking to grow our Huntington Beach, CA location and hire a Project Manager to support Engineering. Come join the team where technical and business minds collaborate to focus on Replacing Hearts and Restoring Lives.


The Engineering Project Manager (EPM) will support the organization in the development of project plans and schedules while ensuring budgets and actual costs are consistently tracked, analyzed and maintained through close collaboration and communication with team leaders. Utilizing their project management expertise, the EPM will guide and assist team leaders in successfully completing the BiVACOR implantable Total Artificial Heart (TAH) development projects.


The Engineering Project Manager will primarily manage the TAH development projects and program schedule and will facilitate meetings to present project schedule status, identify priorities, opportunities, risks, issues and resource allocation.  The Engineering Project Manager will also support the team to ensure the scheduling is in alignment with BiVACOR’s budget and cost modelling. This role will report to the BiVACOR Program Manager and will work with the engineering design & development, manufacturing, verification and validation groups.

 

BiVACOR is looking for motivated team members who are keen to contribute to this active and dynamic project. This role requires creativity and flexibility to find the best solution in a multidisciplinary and dynamic research and development (R&D) environment. Strong leadership in a team environment, organizational, time/project management and technical skills are required.

 

Located in Huntington Beach (CA), BiVACOR is seeking motivated and flexible team members who are keen to contribute to this active and dynamic project. Strong organizational, time management, and technical skills paired with an analytical and problem-solving thinking in a deadline driven environment is needed. This role requires the ability to work with minimal supervision and offers the opportunity for career advancement.


RESPONSIBILITIES

  • Lead project management scheduling for the TAH development, including development and maintenance of each project schedule, track progress of each project, ensure internal and external schedules are integrated and aligned, ensure all necessary activities have been planned and scheduled, liaise with key stakeholders to ensure they are aware of critical tasks and interdependencies, communicate with external vendors to track progress and schedule updates, ensure the schedule presents achievable activities and milestones, undertake resource allocation, identify areas of improvement, and support the Program Manager in planning and scheduling future TAH development activities.
  • Interface with team leaders and stakeholders to update schedules and ensure that schedule data is accurate.
  • Support development of back-up/recovery plans for unplanned setbacks and schedule accordingly.
  • Support the program budget and cost modelling, including the identification, forecasting, variance analysis and tracking of project costs consistent with the detailed project schedules.
  • Assist technical teams with project management and implement resource planning.
  • Support resource allocation analyses to achieve effective allocation of resources across all projects and identify shortfall in resources.
  • Facilitate project meetings including presenting project(s) status, identify priorities, opportunities and resource allocation.
  • Support monthly program reviews with updated schedules, project actual costs with forecasts and collate updates from team leaders.
  • Work with team leaders to identify interdependencies and track cross-functional issues affecting projects, escalating as necessary to the Program Manager.
  • Identify technical, schedule and cost risk with support from the team and develop mitigation and resolution plans.
  • Support Program Manager to organize, coordinate, and chair regular project management team meetings, ensuring common understanding of progress toward agreed milestones and deliverables, identification of risks, and accountability/responsibility for the delivery of tasks, deliverables, and milestones.
  • Be the go-to person for week-to-week project activities and status update.
  • Other project management duties as directed by the Program Manager.


REQUIREMENTS

  • Bachelor’s degree or higher in Engineering (Electrical or Mechanical).
  • Relevant work experience with at least 3 years’ experience as project manager in Class II or III medical device development.
  • Experience in medical device industry with knowledge of engineering design & development, manufacture, and Verification and Validation activities and standards (FDA, ISO, ISO 14708, ISO 13485, ISO 9001).
  • Proficient in Office 365 software and other program management tools.
  • Project management qualifications such as Project Management Professional (PMP).
  • Demonstrated strong leadership and interpersonal skills.
  • Strong verbal and written communication skills.


Occasional travel may be required, up to 2 weeks per year.


Compensation Range: $115,000 – 150,000 + bonus + benefits

The above represents the expected salary range for this job requisition. Ultimately, in determining pay, we’ll consider job location, experience, and other job-related factors.


BiVACOR offers a competitive compensation package to include a 401k with match, generous time off, a choice of healthcare plans and an array of other benefits. In addition, this position will be eligible for short-term and long-term incentive programs.


About the Company

BiVACOR® is a preclinical stage medical device company developing the BiVACOR Total Artificial Heart (TAH), the first long-term therapy for patients with severe heart failure. The TAH is designed to replace the complete function of the native heart and address the global unmet need of patients with end-stage heart failure (HF) by providing a next generation life-extending solution.

Headquartered in Houston, TX with an engineering office in Huntington Beach, CA, and an international office in Brisbane, Australia, BiVACOR was founded in 2008 by a team of internationally renowned biomedical engineers and cardiac surgeons, including Chief Technical Officer, Daniel Timms PhD and Chief Surgical Officer, William Cohn MD. The original IP was developed by Daniel Timms who continues to collaborate with various researchers and institutes in Australia. Our highly driven and performing team has complementary science and business minds to focus on “Replacing Hearts and Restoring Lives”. 


Today, BiVACOR has a robust collaborative network that extends nationally and internationally and boasts a team of world-class engineers, medical specialists, and business executives fervent to advance this ground-breaking technology. Core to us and our culture is collaboration, working hard and recognizing those around us. To learn more about us go to www.bivacor.com


BiVACOR is an equal opportunity employer. We are committed to creating an inclusive environment for all employees. Our employment decisions are based on individual qualifications, job requirements and business needs without regard to race, color, marital status, sex, sexual orientation, gender identity and/or expression, age, religion, disability, citizenship status, national origin, pregnancy, veteran status and or any other legally protected characteristics. We are committed to providing reasonable accommodation, if you need an accommodation to complete the application process, please email hr@bivacor.com


BiVACOR does not accept profiles or resumes from recruiting firms without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by BiVACOR, implied or otherwise.

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