Project Manager

Project Manager / Sr. Project Manager

Location: Santa Clara, CA

Travel: Occasional -- 10-20%

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.

General Responsibilities:

• Reports to the VP, PMO
• 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

Specific Responsibilities and Skills:

• 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

Expertise and Attributes:

• A passion for supporting an emerging company and sustaining high growth through engineering support
• Have a demonstrated ability to communicate effectively in written and oral interactions.
• Have a basic cross-disciplinary understanding of a medical device business emphasized on engineering, manufacturing, operations, R&D, clinical and regulatory and quality assurance
• Has excellent reading, writing, and analytical skills
• Experience in orthopedics is highly desired, spine experience also a plus
• Have a track record for leading successful initiatives through innovative solutions and cost-effective methodologies, followed by product support and improvement
• 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
• 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 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

Knowledge, Education and Experience:

• 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.
• Design and change control experience is highly desired.
• 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

Salary range:  $117,000- $130,000 for Project Manager; $150,000-170,000 for Sr. level. The compensation range for this position is specific to the location, experience and level and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors.

Supplemental pay: bonus and stock