Senior Quality EngineerFebruary 7, 2019
Allurion Technologies is a rapidly growing medical device company based in Natick, Massachusetts with offices in Paris and Dubai. 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.comfor further information.
ROLES AND RESPONSIBILITIES
Under the direct supervision of the Director of Quality Assurance, the Sr. Quality Engineer will be responsible for supporting new product development activities and developing and implementing manufacturing processes and controls to support product quality. The qualified candidate will be a core member of the quality assurance team and will play an essential role to ensure the safety of the Elipse Device and the ongoing commercial success of Allurion.
Specifically, the Sr. Quality Engineer will be responsible for the following activities:
- Support the development and manufacturing of Class III medical devices in conformance with the Quality System Regulation, Medical Device Directive, ISO 13485, ISO 14971, ISO 62366 and other industry related Regulations and Standards.
- Support New Product Development activities from Concept through Launch as a Design Control Subject Matter Expert and core team member.
- Evaluate new or modified product designs for manufacturability, serviceability, testability, reliability, and capability.
- Assist in new product design and process changes to ensure that effective controls and requirements are established.
- Develop process validation protocols and support process validations in accordance with applicable standards, regulations, and guidelines.
- Lead Risk Management activities as a Subject Matter Expert in accordance with EN ISO 14971:2012.
- Update and review existing documentation related to DHF’s, manufacturing, testing, process development, and process validation, to identify risks that could impact product quality.
- Review and approve process changes throughout the product lifecycle. Review activities may include: verifying application of quality engineering principles during process design, verifying process testing data or reports, evaluating quality and risk documentation & metrics, and others.
- Develop and/or revise routine procedures, work instructions, and test methods.
- Support, create, review, and approve engineering and document change orders and implement approved changes.
- Document all activities in compliance with applicable standards, regulations, and guidelines.
- Monitor outgoing product quality via review of documentation such as nonconforming reports and lot history records.
- Assist in investigations of quality issues arising from product complaints, CAPAs, and non-conforming reports.
- Assist with internal and supplier audits.
- Utilize problem solving tools to analyze and identify root causes and implementing corrective actions.
- Make decisions and proposing solutions based on calculated risks identified through data analysis.
- Bachelor’s degree, prefer technical such as engineering or biomedical.
- Must have 3-5 years of Medical Devices experience with direct responsibilities related to Design Quality and Manufacturing.
- Excellent interpersonal and communication skills, as well as a demonstrated ability to work well with cross functional teams.
- Goal oriented with a positive attitude and a willingness to take initiative and solve problems creatively, independently, efficiently, and with an attention to detail.
- Ability to handle multiple assignments in a fast-paced environment with changing priorities.
- Ability to uphold a high standard for professionalism.
- Confidence with Minitab, Microsoft Windows, Microsoft Office.
- DFSS or DMAIC Black Belt Certified, preferred
- Certified Quality Engineer (CQE), preferred
- Certified Quality Auditor (CQA), preferred
COMPENSATION AND BENEFITS
- Salary will be commensurate with prior experience
- Comprehensive medical, dental, vision, life and disability insurance
- Tuition reimbursement
- Newborn baby care allowance
- Generous holiday schedule
- 3 weeks paid time off
- Stock options
- Company-matched 401K savings plan
Must be authorized to work in the US.
If you are a qualified applicant, please submit your resume to: HR@allurion.com
Allurion is an equal opportunity employer.