Senior Project Manager - Santa Clara, United States - Bayside Solutions

Description

Senior Project Manager

Direct Hire Fulltime Role

Salary Range: $109,200 - $130,000 per year

Location: Santa Clara, CA - Hybrid Role

Duties and Responsibilities:

• Report to the Vice President of Project Management
• Develop expertise in Microsoft Project.
• Integrate individual project schedules into a consolidated schedule.
• Assess resource utilization and make recommendations to reallocate resources across projects. Decide on the number of projects that can be completed the most efficiently and initiate the next project.
• Expand the scope of other non-product and quality-related projects such as IT projects, facility changes, etc.
• If bandwidth permits, lead an individual project as a project manager
• Interact with members of all functional departments.
• Responsible for performing all duties in compliance with all applicable worldwide regulatory requirements
• Act and conduct company business honestly, ethically, and lawfully, consistent with the company Code of Conduct, other company policies, the AdvaMed Code of Conduct, and any other applicable industry code(s) of conduct. Retaliation in connection with making good-faith reports of suspected violations is not tolerated.
• Control the consolidated project timelines and deliverables.
• Work directly with the Vice President of Project Management and project managers to suggest efficiency improvements.
• Take an active role in understanding, communicating, and addressing any impediments to the schedule.
• Streamline projects and activities as much as possible while working closely with Quality to ensure compliance.
• Assist with Operations activities as appropriate and as requested.
• Create and implement metrics and communication to ensure team commitments (scope, project plan, resources) are met and communicated promptly.
• Work with interdepartmental teams to build project schedules, track inventory, use budgets, and lead all aspects of deadlines to help ensure that products are launched on time and meet established goals and objectives (per project plan) to support the organization's goals.
• If bandwidth permits, lead select projects within the portfolio and make commitments to meet specific business goals and objectives
• Continually evaluate the project timelines to identify upcoming hurdles and possible areas of project acceleration.
• Assist coworkers where possible in project tasks.
• In the event of potential non-compliance with applicable standards or regulations (e.g., FDA QSRs, ISO 13485, or ISO 14971), the employee has the authority to hold any product or Quality documentation from shipment or further processing. The employee has the responsibility and authority to report any instances to Quality or Regulatory and the respective management team.
• Support the company's quality systems.

Requirements and Qualifications:

• Bachelor's degree
• Project Management Professional (PMP) Certification
• A passion for supporting an emerging company and sustaining high growth through engineering support
• Have a demonstrated ability to communicate effectively, manage projects, and understand the interaction of multiple parallel activities.
• Have a working cross-disciplinary understanding of the medical device business, emphasizing engineering, manufacturing, operations, R&D, clinical and regulatory, and quality assurance.
• Has excellent reading, writing, and analytical skills
• Expertise in Microsoft Project and Project Online
• Currently or recently served as project manager for a high-growth medical device organization whose products are marketed to a medical specialty practice and worked in that capacity for a minimum of 10 years.
• Experience in orthopedics is highly desired; spine experience is also a plus.
• Have a track record for leading successful projects through innovative solutions and cost-effective methodologies, followed by product support and improvement.
• Be known as someone with high integrity, sound character, a tremendous work ethic, and a passion for success.
• Perform responsibilities with a professional 'can do' attitude.
• Think of ways the project impacts the entire organization.
• Continually ask questions to fully understand each project and be able to communicate details to each team member.
• Knowledge and familiarity with applicable regulations/standards (e.g., ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO as required to perform the job function

Desired Skills and Experience

Project Management, Medical Device (Spine), Quality Assurance, PMP, Microsoft Project, Regulatory, FDA

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