Project Manager (Risk Management)

SOPHiA GENETICS

Boston, MA, US
  • Job Type: Full-Time
  • Function: Engineering Prod Mgmt/Dev
  • Post Date: 01/17/2021
  • Website: sophiagenetics.com
  • Company Address: 185 Dartmouth Street, Suite 502, Boston, MA, 02116

About SOPHiA GENETICS

SOPHiA GENETICS combines deep expertise in life sciences and medical disciplines with mathematical capabilities in data computing. Our mission is to bring data analytics solutions to market, to support healthcare professionals by maximizing the power of Data-Driven Medicine. We achieve this mission through the global adoption of SOPHiA AI, which is built using techniques such as statistical inference, pattern recognition and machine learning. This enables SOPHiA to provide equal benefits to all users, unite experts in a gold standard health tech platform, and motivate expert knowledge sharing for a sustainable impact on future patients.

Job Description

Would you like to be part of a dynamic and exciting team delivering high level performance that has a direct impact on the lives of cancer and rare disease patients worldwide? Join our growing team and use your exceptional technical and organizational skills to help us deliver on our mission of democratising Data-Driven Medicine. Our products are used by over a thousand healthcare institutions globally and provide world leading capabilities for the analysis of genomic, clinical, and imaging data.

Be part of our mission to disrupt the healthcare and democratise the data driven medicine! SOPHiA is looking for a Project Manager to join the Quality team in Boston.

The Risk Management Project Manager is responsible for management of Risk activities related to SOPHiA products in adherence to ISO 14971 and FDA/IVDR/MDR requirements.


Missions:

    Lead and coordinate all risk management activities according to ISO 14971
    Ensure harmonized approaches to risk management across projects.
    Ensure that all hazards associated with a medical device are identified, the associated risks are estimated and evaluated and that these risks are controlled; monitors that these risk controls are implemented, verified and validated.
    Manage the Risk Management Databank
    Monitor that risk control measures have been implemented, verified and validated
    Collection and systematic review of information about the product in the production and post production phase
    Ensuring complete risk management documentation with responsibility of further developing and implementation ISO 14971 in the internal risk management process for medical devices during their entire life cycle
    SME for Risk Management and will assist design teams and Quality on Risk
    Planning and execution of risk management activities with project managers

    Contribution to continuous improvement of risk management process
    Ensure that risk managements reports are prepared in a timely manner and in accordance with ISO 14971 and applicable company SOP and guidelines and are adequate for inspection by notified bodies, EMEA, FDA and other relevant authorities

    Representation of the risk management in audits and assessment

Requirements

    8+ years experience with medical device and member of a design team
    Bachelors Degree required; Advanced degree preferred
    Experience designing medical devices, software as medical device experience preferred
    Good Knowledge of Medical standards: ISO 14971, ISO 13485, IEC 62304, 21CFR 820
    Knowledge in usage of risk assessment methods: FTA, FMEA, PHA
    Knowledge of relevant methods, industry standards and trends within risk management for medical devices including SaMD
    Knowledge of relevant methods, industry standards and trends within information security risk management (ISO/IEC 27001)
    Good English Skills reading, writing, and speaking

Benefits

    Career opportunities in a fast-growing company with worldwide reputation
    A flexible and friendly working environment with a collaborative atmosphere
    Fantastic office locations in Boston
    An exciting company mission that brings together science and technology to directly impact the lives of patients with life threatening illness.
    A fast-growing company with plenty of opportunity for personal growth and development

Location: Saint-Sulpice

Starting date: ASAP,

If you think you fit this position, please send a CV and a cover letter.

Please note that incomplete applications will not be considered.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.