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SI-BONE · 2 days ago

Project Manager/ Senior Project Manager

Santa Clara, CA

Full-time

Onsite

Senior Level

$140K/yr - $160K/yr

5+ years exp

SI-BONE is a fast-growing, publicly traded medical device company that focuses on minimally invasive sacropelvic solutions. They are seeking a Project Manager/Senior Project Manager to manage project timelines, collaborate with cross-functional teams, and ensure compliance with regulatory requirements while driving initiatives that align with company objectives.

Medical Device

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

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 stakeholders 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

Support the SI-BONE Quality System

Qualification

Medical Device Design ControlRegulatory ComplianceProject ManagementMicrosoft ProjectCross-Disciplinary UnderstandingAnalytical SkillsCommunication SkillsTeam PlayerIntegrityProblem-Solving

Required

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

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

Benefits

Bonus

Stock

Company

SI-BONE

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.

Founded in 2008

Santa Clara, California, US

201-500 employees