Project Manager

SI-BONE, Inc•Santa Clara, CA

48d•$117,000 - $170,000•Onsite

About The Position

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy. SI-BONE® is focused on helping patients in one of the most under-served, under-diagnosed, and under-treated areas in orthopedics, the sacroiliac (SI) joint. SI-BONE developed an innovative, patented implant to fuse the SI joint. The iFuse Implant System® provides a less invasive alternative to traditional sacroiliac (SI) joint fusion surgery and has been used in over 90,000 procedures to date. We are a medical device company that is focused on improving the lives of patients with sacroiliac pelvic conditions. We are looking for people who are passionate about our mission and who are willing to work hard to achieve it. We are also looking for people who are: Agile: We work in a fast-paced environment and need to be able to learn and adapt to change quickly. Creative: We embrace creativity, and we need people who are not afraid to challenge the status quo. Team Players: We roll-up our sleeves and work together as one team to achieve our goals. We are seeking a highly analytical and detail-oriented individual to join our growing PMO team. In this role, you will play a key role in leading our ever growing project portfolio and support continuous improvement of our systems and processes.

Requirements

Bachelor’s degree in related field, preferably biomechanical or mechanical engineering degree.
4+ years of project management experience within the medical device industry is a must, preferably with similar orthopedic spine products.
Cross functional support experience across R&D with development of new products to launch, Clinical, Manufacturing, Engineering, IT, Operations and other functions.
MS Project and managing project schedules

Nice To Haves

Experience in orthopedics is highly desired, spine experience also a plus
Design and change control experience is highly desired.

Responsibilities

Manage timelines and responsibilities of select projects
Interact with members of all functional departments
Work with cross-functional team to ensure projects stay on track and organized.
Responsible for performing all duties in compliance with all applicable worldwide regulatory requirements as included in the scope of the SI-BONE Quality Manual
Act and conduct company business in an honest, ethical and lawful manner, consistent with the company’s Code of Conduct, other company policies and the AdvaMed Code of Conduct and/or any other applicable industry code(s) of conduct. The company does not tolerate retaliation in connection with making good faith reports of suspected violations
Create and manage project timelines for multiple initiatives. Coordinate and delegate tasks while maintaining alignment with the larger PMO department.
Assign, coordinate, and assist with deliverables from project initiation stage to launch, including leading or participating in cross-functional meetings outside of regularly scheduled engineering/design control meetings.
Take an active role in understanding and communicating any impediments to the schedule.
Streamline projects and activities as possible while working closely with Quality to ensure compliance
Assist with Operations activities as appropriate and as requested
Assist with non-conformances, design changes, CAPAs, etc on an as-needed basis.
Create and implement metrics and communication to ensure team commitments (scope, project plan, resources) are met and communicated in a timely manner
Manage 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
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 and/or Regulatory and the respective management team
Support the SI-BONE Quality System