Project Manager/ Senior Project Manager

SI-BONE, Inc•Santa Clara, CA

2h•$140,000 - $160,000

About The Position

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.

Requirements

Minimum bachelor’s degree in an engineering or technical field
Minimum 5 yrs Experience in Project/Program Management
Passion for supporting an emerging company and sustaining high growth through driving complex initiatives.
Demonstrated ability to communicate effectively and work well with coworkers, physicians, and leadership.
Deep understanding of medical device design control and demonstrated commitment to quality.
A working cross-disciplinary understanding of a medical device business including engineering, manufacturing, operations, R&D, clinical, regulatory, and quality assurance
Excellent reading, writing, and analytical skills
Expertise in Microsoft Project and/or other similar project management software.
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 5 years
A track record for managing successful engineering projects through innovative engineering solutions and cost-effective manufacturing, followed by product support and improvement.
Knowledge and familiarity of applicable regulations/standards (e.g. ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971) as required to perform the job function
Be known as a person who has high integrity, sound character, a tremendous work ethic and the passion to succeed
Perform responsibilities with a professional “can do” attitude
Ability to take ownership of projects while understanding and communicating their impacts on the entire organization.
Continually ask questions to fully understand each project and be able to communicate details to each team member.

Nice To Haves

Experience in orthopedics is highly desired, spine experience also a plus

Responsibilities

Manage timelines and responsibilities of select projects
Interact with members of all functional departments
Work with Product Management to strategize and implement initiatives and prioritize projects to meet company objectives.
Responsible for performing all duties in compliance with all applicable worldwide regulatory requirements as included in the scope of the SI-BONE Quality Manual
The employee must at all times act and conduct company business in an honest, ethical and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code and all applicable laws and regulations, whether national, regional, state or local. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code or any other Company policy, and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations
Independently create and manage project timelines for multiple initiatives. Coordinate and delegate across projects that comprise the program(s) under the individual’s responsibility.
Assign, coordinate, and assist with deliverables from project initiation stage to launch, including leading cross-functional meetings outside of regularly scheduled engineering/design control meetings.
Work with management and Product Marketing to establish early-stage project plans, including drafting business cases, project scoping within the context of existing programs, resourcing, and budgeting.
Take an active role in identifying, analyzing, communicating, and overcoming any project or project risks. When appropriate, escalate to organizational leadership.
Actively identify project risks and opportunities and guide solutions-based discussions. Effectively achieve consensus among stake holders and communicate key decisions to leadership.
Streamline projects and activities as possible while working closely with Quality to ensure compliance
Assist with and manage Quality activities, such as audit responses, as appropriate and as requested
Assist with or manage Operations programs and activities as appropriate and as requested
Create and implement metrics and communication to ensure team commitments (scope, project plan, resources) are met and communicated in a timely manner.
Independently manage key organizational initiatives, including projects that represent company-wide corporate goals.
Manage select projects within the portfolio and make commitments to meet specific business goals and objectives
Proactively evaluate project timelines to identify upcoming hurdles and possible areas of project acceleration
Assist coworkers where possible in project tasks.
Support design and development of medical instrumentation, equipment, and procedures, using the principles of engineering
Assist with evaluation of safety, efficiency, and effectiveness of products and with verification and validation planning.
Assist with non-conformances, design changes, CAPAs, etc on an as-needed basis.
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 his respective management team
Support the SI-BONE Quality System