Senior Project ManagerSeptember 28, 2018
Allurion Technologies is a rapidly growing medical device company located in Natick, Massachusetts. The Company developed and markets the Elipse™ Device, an innovative device for the treatment of overweight and obese patients. The device is placed in a 15-minute office visit and does not require surgery, endoscopy or anesthesia for placement or removal.
The Elipse Device was recognized as the top emerging technology of 2016 by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Search Elipse Balloon online or visit our website www.allurion.com for further information.
Seeking a strong Project Manager from the medical device space who has a proven track record of managing projects from Concept through Commercial stages. This individual must have a broad range of technical experience in the fields of engineering, product development, and project management. The ideal candidate will be self-motivated and thrive in a fast-paced entrepreneurial environment.
- Manage multiple engineering projects from concept to commercialization. Plan, develop, coordinate, and direct engineers and other cross-functional team members to achieve project objectives.
- Directly responsible for the Design Control elements of ISO 13485 as it relates to new product development.
- Create and maintain design control documentation such as Product Specifications, Risk Management Reports, Design Verification and Validation Plans and Reports, Master Process Validation Reports, and Design History Files
- Plan, schedule, and lead design reviews
- Draft verification and validation plans and reports with a focus on design verification and validation execution.
- Review engineering deliverables and initiate appropriate corrective actions when needed
- Become a cross functional liaison between R&D, regulatory, quality, manufacturing and operations
- Estimate and track project budgets and timelines
- Update colleagues and management on status of assigned projects
- Must have minimum of 5+ years of project management experience
- BS degree in Manufacturing or Mechanical Engineering or related technical discipline
- Project Management certification (PMP) is desired
- Must have a minimum of 3 years of product development experience in the medical device industry
- Must have experience working cross functionally with R&D, regulatory, quality, manufacturing and operations
- Attention to detail and precision is a must
- Strong, hands-on problem solver
- Experience managing FDA class III products is desired, will consider class II background
- Must have ISO13485 and FDA experience
- Must have strong cGMP and GDP experience
- Must have ability to lead, plan, execute, and document projects independently
Must be authorized to work in the US without sponsorship.
Qualified applicants should submit a resume and expected salary to: HR@allurion.com
Allurion is an equal opportunity employer.
PLEASE NOTE: We are not using agencies to fill this opportunity.