Senior Project Managerjuillet 19, 2019
Allurion Technologies is a rapidly growing, global, venture-backed healthcare company headquartered in Natick, Massachusetts with offices in Paris and Dubai. The Company was founded in 2009 by two Harvard Medical School students dedicated to helping consumers lose weight. The Company’s flagship program features the Elipse Balloon, a procedureless device for the treatment of overweight and obese consumers, an Allurion Bluetooth® body composition scale, and an Allurion smartphone app that tracks the user’s progress throughout their weight loss journey. The program leads to 25 to 30 lbs of weight loss in 4 months. The Elipse Balloon is placed in a 15-minute office visit and does not require surgery, endoscopy or anesthesia for placement or removal. The Company launched commercial operations in 2016, and 15,000 consumers have already experienced the Elipse Program across 20 countries in Europe, the Middle East, and Latin America. In 2018, the company commenced a pivotal study for FDA approval which is now complete. Allurion has been recognized as one of Fierce Medical Device’s Fierce 15, one of Boston’s 50onFire, and a top Emerging Technology by SAGES.
Seeking a candidate that has a strong engineering and project management background with a proven track record of managing cross functional 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 cross functional projects from concept to launch and inclusive of post launch activities. Plan, develop, coordinate, and direct engineers and other cross-functional team members to achieve project objectives.
- Directly responsible for applicable elements of 21CFR and ISO 13485 as it relates to new product development and product changes.
- 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 cross functional project deliverables and initiate appropriate corrective actions when needed
- Become a cross functional liaison between R&D, regulatory, quality, manufacturing engineering, operations, and sales and marketing
- Estimate and track project budgets and timelines
- Update colleagues and management on project status
- Must have minimum of 5 years of project management experience
- BS degree in a relevant engineering discipline is required
- Project management certification (PMP) is desired
- MBA or MS in management is desired
- Must have a minimum of 3 years of medical device product development experience
- Attention to detail and precision is a must
- Strong, hands-on problem solver
- Experience managing FDA class III and or PMA products is desired
- Must have ISO13485 and FDA experience
- Strong cGMP and GDP experience
- Working knowledge of manufacturing processes and validation (IQ/OQ/PQ/PQ)
- Proficient with statistical methods for data analysis and acceptance
- Ability to lead, plan, execute, and document projects independently
Must be authorized to work in the US.
- Market salary, commensurate with prior experience
- Stock options
- Company-matched 401K savings plan
- Comprehensive medical, dental, vision, life and disability insurance
- Tuition reimbursement
- Newborn baby care allowance
- 3 weeks paid time off
- Generous holiday schedule
Search Elipse Balloon online or visit our website www.allurion.com for further information.
Qualified applicants should submit a resume to: HR@allurion.com
Allurion is an Equal Opportunity Employer