NPI Project Manager

SI-BONE, Inc; San Jose (CA); On-site; USD 125,000 - 140,000; Full time

Job summary

SI-BONE, Inc is seeking a Project Manager, NPI in San Jose, CA to lead key initiatives, manage timelines, and coordinate engineering, product management, quality, and regulatory teams for timely, compliant delivery.

The role requires a bachelor’s degree in engineering or a technical field and at least five years of project/program management experience, with strong communication and leadership in a fast-growing medical device environment. Occasional travel up to 20% is expected.

Qualifications

• Minimum bachelor’s degree in an engineering or technical field.
• Minimum 5 yrs Experience in Project/Program Management.
• Strong communication and cross-functional leadership skills.
• Experience leading medical device programs and regulatory awareness.

Responsibilities

• Manage timelines and responsibilities of select projects.
• Coordinate cross-functional meetings with engineering, product management, quality, and regulatory.
• Lead early-stage project planning and business case development.
• Identify, analyze, and mitigate project risks; escalate when needed.
• Create metrics and communications to ensure commitments are met.
• Ensure compliance with applicable standards (FDA QSR, ISO 13485/14971).
• Support design and development of medical instrumentation and processes.
• Work with management to align projects with company objectives.

Skills

Project management

Leadership

Cross-functional collaboration

Communication

Risk management

Education

Bachelor's degree in engineering/technical field

Tools

Microsoft Project

Job description

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.

Project Manager, NPI

Location: San Jose, 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. Today, we continue to advance what fixation can accomplish, and expand who it can benefit, by applying our deep expertise in precision-engineered implants to a critical new challenge: osteoporotic bone. Our latest implant, iFuse Granite Onyx™, addresses that challenge as the third SI-BONE platform to receive FDA Breakthrough Device designation, meeting a known, large unmet need in spinal fusion procedures.

Guided by our ethos of serving the greater good through ethical patient care, we build on four core competencies:

• Scientific Innovation
• Clinical Proof
• Regulatory Leadership

We’re recreating Stability Inside even the most fragile bone.

We are a medical device company that is focused on improving the lives of patients with sacroiliac pelvic conditions. We’re looking for people who share our passion for this mission and are committed to achieving it. We’re 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 NPI 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 Associate Director, NPI Program Management
• 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

Specific Responsibilities and Skills:

• Manage key NPI, product enhancement, or non-standard product initiatives with limited supervision.
• 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, escalation 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
• 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
• Proactively evaluate project timelines to identify upcoming hurdles and possible areas of project acceleration
• Assist coworkers where needed 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

Expertise and Attributes:

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

Knowledge, Education and Experience:

• Minimum bachelor’s degree in an engineering or technical field
• Minimum 5 yrs Experience in Project/Program Management

Salary range: $125,000- $140,000. 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

There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For additional information on the company or the products including risks and benefits, please visit www.si-bone.com/risks.