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Carmat

9 results

Methods Engineer – Cleaning and Sterilization Processes (F/M)

Carmat

Job Category
Manufacturing
Posted Date
Apr 18, 2023
Location
Bois-d'Arcy, Yvelines, France
Full Time
Methods Engineer – Cleaning and Sterilization Processes (F/M)
Apply Now

Carmat

Job Category
Manufacturing
Posted Date
Apr 18, 2023
Location
Bois-d'Arcy, Yvelines, France
Full Time

Job Description

CARMAT aims to respond to a major public health issue related to cardiovascular diseases, the main cause of death in the world: heart failure. Thanks to the continious development of its "total artificial heart", CARMAT aims to overcome the notorious lack of grafts that tens of thousands of people suffer from heart failure. To do so, the Methods team is currently looking for a methods engineer - cleaning and sterilization processes

Missions
  • Cleaning / sterilization / biological evaluation:
  • Strategy definition, production follow-up, lab coordination (internal/external)
  • Protocols and reports writing for tools qualification (IQ/OQ/PQ) / testing validation
  • Protocols and reports writing for biological evaluation
  • Manufacturing process optimization, instructions, and control sheets elaboration
  • Operating staff empowerment
  • Operator training and change management
  • Document management (non-conformities, CAPA, FMECA, Change Request…)
  • Audit referent (answer to authorities)
  • Coordination and monitoring of routine checks
Knowledge and skills
  • moisture heat, chemical, ethylene oxide and irradiation sterilization (expert)
  • Cleaning process (expert)
  • Chemistry, microbiology (mastery)
  • Amélioration des processus de fabrication (mastery)
  • Project management, planning management (mastery)
  • English (mastery)
Required profile

Bac +5 specialized in industrial cleaning and sterilization process

3 years and more MD/pharma industrial cleaning

Apply Now

Clinical Specialist Germany (F/M)

Carmat

Job Category
Clinical
Posted Date
Apr 18, 2023
Location
Germany
Full Time
Remote
Clinical Specialist Germany (F/M)
Apply Now

Carmat

Job Category
Clinical
Posted Date
Apr 18, 2023
Location
Germany
Full Time
Remote

Job Description

CARMAT, designer and developer of the most advanced total artificial heart project in the world, aimed at offering a therapeutic alternative to patients suffering from end-stage bi-ventricular heart failure, is recruiting a Clinical Specialist for Germany.

Missions & Responsabilities
  • Provide clinical and technical support of Carmat Assist Device Systems (TAH) in the assigned geographical area.
  • Provide training, in service support and clinical assistance for new and existing Carmat customers, potential customers, distributors and their clinical and sales specialists.
  • Work with Integrity and communicate regularly with management to keep them informed of what is being observed in the field relative to Carmat and other VAD players or competitors.
  • During study phase, work with customers to identify suitable candidate for the Carmat study.
  • Responsible for providing technical and clinical support to customers, sales team and distributors.
  • Participate in 24 hours/7 days support to customers
  • Coordinate and assist all centres in an assigned geographical region with the training manager
  • Maintain contact with customers in order to assess clinical and educational needs.
  • Evaluate customer needs and recommend appropriate product modifications or assessments.
  • With the training manager, create, maintain, and update educational materials.
  • Assist in the promotion of Carmat’s product to prospective clients in cooperation with the sales team and distributors.
  • Evaluate product viability and planned product improvements and modifications.
  • Complete clinical reports as requested by management, and completes all additional documentations requested by management in a timely basis.
  • Protect and act responsibly towards all company equipment and confidential information.
  • Provide support at Trade shows as requested by management.
  • Maintain a good driving record.
  • Ability to work effectively from a home office base and must provide the majority of their own typing, filing, and communications support.
  • Perform other duties as assigned by supervisor.
  • Pro-actively and consistently communicate and provide necessary information within team and cross functional departments to achieve the Company goals and enhance business practices
Profile
  • Carmat product and mechanical circulatory support field and environment expertise.
  • Master in physiopathology in Heart failure.
  • Notions of drugs and device treatment of Heart failure.
  • Ability to coordinate a high level of activity under a variety of conditions and constraints.
  • Physician Degree or some other medical discipline. Graduate Degree desirable.
  • Mother of the assigned area in required
  • Fluent german and english
  • Previous experience within the VAD industry is a plus.
  • Cardiac Care experience preferred.
  • Proven competency as a Clinical Specialist or similar role within the HF industry.
  • Bio medical engineer Physician (ICU or CCU), clinical publications, and group presentations experience desirable.
  • Computer literacy required.
Location
  • Home office base

The person occupying the position must be able to travel extensively including internationally if required.

Apply Now

Clinical Specialist (F/M)

Carmat

Job Category
Clinical
Posted Date
Apr 18, 2023
Location
Full Time
Remote
Clinical Specialist (F/M)
Apply Now

Carmat

Job Category
Clinical
Posted Date
Apr 18, 2023
Location
Full Time
Remote

Job Description

Carmat aims to meet a major public health challenge related to cardiovascular diseases, namely heart failure, the leading cause of death in the world. More specifically, Carmat aims to provide a lasting solution to the treatment of terminal heart failure, a disease for which there are very few effective options today - the main one being heart transplants – and affecting at least 26 million people worldwide. Thanks to its unique design and physiological functions, the CARMAT total artificial heart could, subject to the success of ongoing clinical trials, save the lives of thousands of patients each year, without risk of rejection and preserving their quality of life.

Missions and Responsabilities
  • To provide clinical and technical support of Aeson predominately in Europe, especially France and Germany.
  • Provide training, in service support and clinical assistance for new and existing Carmat customers, potential customers, distributors and their clinical and sales specialists.
  • Work with Integrity and communicates regularly with management to keep them informed of what is being observed in the field relative to Carmat and other VAD players or competitors.
  • During study phase, work with customers to identify suitable candidate for the Carmat study. 
  • Responsible for providing technical and clinical support to customers, sales team and distributors.
  • Participates in 24 hours/7 days support to customers • Coordinates and assists with the training manager of all centres in an assigned geographical region
  •  Maintains contact with customers in order to assess clinical and educational needs.
  • Evaluates customer needs and recommends appropriate product modifications or assessments.
  • With the training manager, creates, maintains, and updates educational materials. 
  • Assists in the promotion of Carmat’s product to prospective clients in cooperation with the sales team and distributors.
  • Evaluates product viability and planned product improvements and modifications.
  • Completes clinical reports as requested by management, and completes all additional documentations requested by management in a timely basis.
  • Protects and acts responsibly towards all company equipment and confidential information.
  • Provides support at Tradeshows as requested by management.
  • Maintains a good driving record.
  • Ability to work effectively from a home office base and must provide the majority of their own typing, filing, and communications support.
  • Performs other duties as assigned by supervisor.
  • Pro-actively and consistently communicates and provides necessary information within team and cross functional departments to achieve the Company goals and enhance business practice
Knowledge & Skills:
  • Carmat product and mechanical circulatory support field and environment expertise.
  • Master in physiopathology in Heart failure.
  • Notions of drugs and device treatment of Heart failure.
  • Ability to coordinate a high level of activity under a variety of conditions and constraints.
Educational requirements:
  • Physician Degree or some other medical discipline. Graduate Degree desirable.
  • English mother Tung,
  • German second language
Experience
  • Previous experience within the VAD industry is a plus.
  • Cardiac Care experience preferred.
  • Proven competency as a Clinical Specialist or similar role within the HF industry.
  • Bio medical engineer Physician (ICU or CCU), clinical publications, and group presentations experience desirable.
  • Computer literacy required.
  • Candidate must be highly motivated, have excellent written and verbal communications skills, great desire to help others, composed under stress and well organized
Localization

Home office and business trip all over EMEA

Apply Now

Clinical Research Associate (F/M)

Carmat

Job Category
Research
Posted Date
Apr 18, 2023
Location
Vélizy-Villacoublay, Yvelines, France
Full Time
Clinical Research Associate (F/M)
Apply Now

Carmat

Job Category
Research
Posted Date
Apr 18, 2023
Location
Vélizy-Villacoublay, Yvelines, France
Full Time

Job Description

Carmat aims to meet a major public health challenge related to cardiovascular diseases, namely heart failure, the leading cause of death in the world. More specifically, Carmat aims to provide a lasting solution to the treatment of terminal heart failure, a disease for which there are very few effective options today - the main one being heart transplants – and affecting at least 26 million people worldwide. Thanks to its unique design and physiological functions, the CARMAT total artificial heart could, subject to the success of ongoing clinical trials, save the lives of thousands of patients each year, without risk of rejection and preserving their quality of life.

Missions and Responsabilities

The mission consists in setting up and monitoring international clinical studies in pre-marked and in post-CE marked phases:

  • Perform the selection of the investigational centers, the establishment, the follow-up and the closing of the clinical studies, in collaboration with the Clinical Study Manager.
  • Ensure the monitoring and scientific, technical and regulatory quality of international studies according to ISO14155 and local regulatory requirements if necessary.
  • Contribute to the administrative tasks required to set up and monitor clinical studies (e.g. collection of documents from the center required for regulatory procedures, archiving the Trial Master File sponsor and center)
  • Conduct monitoring and co-monitoring visits to ensure the quality of data collected, source documents and the archiving of investigative documents
  • Work in collaboration with the Clinical Study Manager to identify non-conformities in the conduct of the study, and contribute to the implementation of corrective or preventive actions if necessary
  • To be in contact with the investigating doctors,
  • Revise clinical procedures as needed
  • Contribute to write (e.g. Trial Monitoring Plan) and implement study-specific clinical documents and monitoring tools
  • Prepare centers, and contribute, to audits and inspections
  • Write the visit reports in English
  • Ensure the traceability of the gaps encountered according to a CAPA procedure
Knowledge & Skills
  • Knowledge in Clinical Research and Medical Devices regulatory requirements : ISO 14155, European Regulation of DM 2017/745
  • Knowledge of Good Clinical Practice (ICH-GCP)
  • Knowledge in cardiology and cardiac surgery, will be appreciated
  • Rigor, organization, autonomy
  • Strength of proposal, especially with the investigative centers in the management of gaps.
  • Written and verbal communication abilities
  • Ability to analyze
  • Effective Team working
  • English
Educational requirements and experience
  • Scientific degree BAC +3 
  • Experience in a CRA function of at least 3 years.
  • Experience with FDA, ANSM inspections will be appreciated
Apply Now

Clinical Program Manager (F/M)

Carmat

Job Category
Project Management
Posted Date
Apr 18, 2023
Location
Vélizy-Villacoublay, Yvelines, France
Full Time
Clinical Program Manager (F/M)
Apply Now

Carmat

Job Category
Project Management
Posted Date
Apr 18, 2023
Location
Vélizy-Villacoublay, Yvelines, France
Full Time

Job Description

Carmat aims to meet a major public health challenge related to cardiovascular diseases, namely heart failure, the leading cause of death in the world. More specifically, Carmat aims to provide a lasting solution to the treatment of terminal heart failure, a disease for which there are very few effective options today - the main one being heart transplants – and affecting at least 26 million people worldwide. Thanks to its unique design and physiological functions, the CARMAT total artificial heart could, subject to the success of ongoing clinical trials, save the lives of thousands of patients each year, without risk of rejection and preserving their quality of life.

Missions and Responsabilities

Clinical Program Management

  • Responsible for managing Clinical Program (CP) activities as assigned by the CAM with an entrepreneurial approach that requires the ability to multi-task on a wide spectrum of activities;
  • Plan, coordinate and manage the overall execution of the assigned clinical program to be compliant with quality, budget and timelines, including making or recommending operational strategies and/or decisions (with input from CAM and CMO) in support of achieving clinical program objectives.
  • Coordinate multidisciplinary project team members related to project management activities requiring interaction with internal groups (e.g. Regulatory Affairs, Logistics, Quality Assurance, Marketing and Business Development) and external groups (e.g. external services providers).

Clinical Trial Management

  • Create, contribute to, and implement study-specific clinical documents and monitoring tools: clinical protocol, Informed consent, Trial Monitoring Plan, CRF pages, Safety Records form, and study tracking…
  • Prepare clinical submission and obtain Competent Authorities and Ethics Committee approvals for assigned trials;
  • Define need, identify, assess and set up collaboration with CRO/Strategic Partners.
  • Organize the study management and any logistics required e.g. Corelab, adequate facilities…
  • Provide program and trial-level direction to clinical study team(s) including site management, enrolment, device accountabilities, risk management, communication plans, and monitoring plans in collaboration with CRO/Strategic Partner; Proactively identify potential study issues/risks and recommend/implement solutions
  • Establish the process for the site agreements, contracts, and financial/site payment tracking during study conduct and implement procedures to streamline efforts across multiple departments.
  • Review the Safety data with the CAM/CMO or other vigilance delegate; and report to the Competent Authorities as required
  • Provide operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others.
  • Oversee inspection readiness; Prepare and attend with the study team the audits/inspections, ensure CAPA are established and followed until close-down
  • Ensure quality and adherence to Standard Operating Procedures (SOPs) and compliance with local guidelines and ICH GCPs.
  • Conduct various types of assessment visits to ensure Clinical Operations on-site performance. Develop and oversee training plans to address performance deficiencies.
  • Organize and lead clinical trial meetings at regular intervals. Manages issues and provides follow up for action items requiring resolution. Monitor against progress.

Budget management

  • Responsible for program budget planning and accountable for external spend related to program execution.
  • Trial and site level financial planning and management

Clinical Vendor Management

  • Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program, including escalation of issues.

People management (internal or external)

  • Identify resource needs for the assigned project
  • Assist in recruiting new staff, including participation in interview process and new hire on boarding if required
  • Participate in managing the resource availability for the assigned project
  • Line or Functional management of Clinical Operations staff.
  • Training

Process improvement

  • Support and participate actively to functional initiatives with an impact for Clinical Affairs,
  • Participate in the design, writing and review of Clinical SOPs and associated documents
  • Work closely within appropriate cross business departments to improve staff performance on studies and correct any deficiencies
  • Contribute to Clinical Operations department training initiatives, as appropriate
  • Develop, plan, and lead process improvement projects and initiatives to promote efficiency, simplification and quality
  • Evaluate existing processes and workflows to identify areas that could benefit from changes and/or improvements.
Knowledge & Skills
  • Excellent planning, organization and problem-solving abilities
  • Excellent English writing skills
  • Good Analytical and negotiation skills
  • Demonstrated leadership abilities
  • Demonstrated judgment and decision-making skills
  • Be rigorous and proactive, Change management skills
  • Effective verbal and written communication and presentation skills
  • Expert knowledge in clinical trials design and relevant clinical regulations e.g. ICH/GCP, FDA guidelines, etc
  • Effective Ability to work independently and within a team environment.
  • Fluent English
Educational requirements and experience

Master’s degree in biomedical sciences

Experience in Clinical Project Management experience (at least 5 years)

Apply Now

IS application Architect – IT Project leader (M/F)

Carmat

Job Category
Information Technology
Posted Date
Apr 18, 2023
Location
Vélizy-Villacoublay, Yvelines, France
Full Time
IS application Architect – IT Project leader (M/F)
Apply Now

Carmat

Job Category
Information Technology
Posted Date
Apr 18, 2023
Location
Vélizy-Villacoublay, Yvelines, France
Full Time

Job Description

CARMAT, designer and developer of the world's most advanced total artificial heart project, aimed at offering a therapeutic alternative to patients suffering from terminal biventricular heart failure, is currently looking for an IS Application Architect.

Essential functions
    • Projecting, defining and managing the development of the IS architecture as a whole, to meet the needs of business departments, in line with the company’s strategy and security and risk management policies.
    • Participate in the choice of projects, in terms of evaluation, design and implementation, and ensure that they are integrated into the Information System architecture in a coherent, efficient and sustainable way, while respecting the company’s standards.
    • Take over and manage IT project in full, alongside Business, from user’s need capture to implementation
    • Bringing innovation to all stakeholders (management, business lines, IT) with regard to the existing architecture of the Information System.
Qualifications
  • BAC +5 (engineering or business school)
  • 10 years of professional experience
  • Hybrid cloud/on premise or full cloud architecture context experience
  • Participation to implementation of integrated software packages in industrial companies such as ERP, CRM, BI and MDM in cloud and on premise environment
  • Functional and technical experience
  • Initiative
  • Agility and flexibility
  • Ability to listen, analyze and synthesize
  • Rigor
  • Good interpersonal skills
  • Ability to convince
  • Workshop animation
  • Project management
  • Mastery/expertise of IS architectures

Your profile matches and you wish to work on the most successful artificial heart project in the world, send us your application!

Rémunération

According to profile and experience

Vélizy-Villacoublay (78) with travel to our production site located in Bois d’Arcy.

Apply Now

Clinical Research Informatics Manager (F/M)

Carmat

Job Category
Research
Posted Date
Apr 18, 2023
Location
Vélizy-Villacoublay, Yvelines, France
Full Time
Clinical Research Informatics Manager (F/M)
Apply Now

Carmat

Job Category
Research
Posted Date
Apr 18, 2023
Location
Vélizy-Villacoublay, Yvelines, France
Full Time

Job Description

Carmat aims to meet a major public health challenge related to cardiovascular diseases, namely heart failure, the leading cause of death in the world. More specifically, Carmat aims to provide a lasting solution to the treatment of terminal heart failure, a disease for which there are very few effective options today - the main one being heart transplants – and affecting at least 26 million people worldwide. Thanks to its unique design and physiological functions, the CARMAT total artificial heart could, subject to the success of ongoing clinical trials, save the lives of thousands of patients each year, without risk of rejection and preserving their quality of life.

Missions
  • Manage Clinical Research Informatics Team, consisting of:
    • Medical imaging engineer(s)
    • Database manager(s)
    • Biostatistician
    • Clinical research specialist(s)
  • Service provider for internal departments (Clinical Affairs, Research & Development, Quality, Marketing), and any stakeholders, in close collaboration with corresponding managers:
    • Input for study design and statistical plans
    • Patient selection activities
    • eCRF and database management from development to archive
    • Set up data mining program
    • Statistical and Data output tools and reports for studies and registries
    • Ad hoc data analysis to answer potential request and provide corresponding reports
  • Lead cross-departmental Clinical Evaluation Team:
    • Provide data to support risk, clinical and technical analysis
    • Ensure equivalence to similar devices or device changes is assessed
    • Ensure literature searches review is shared with adequate department
    • Alert about trends, potential risk for patient
    • Delivery of clinical evaluation reports and PMCF evaluation reports within set timeframes
  • Define publication and presentation strategy with CMO and Marketing Manager
    • Organize scientific writing, reviewing and submissions of abstracts and manuscripts
    • Overview publication watchdog function
  • Commissions white papers / position papers on current hot clinical research topics
  • Participate in Medical Advisory Board Meetings
Knowledge & Skills
  • Knowledge of database structures, eCRF, data presentation tools
  • Knowledge of GCP
  • Knowledge of human physiology, device interactions in cardiac domain
  • Effective verbal and written communication and presentation skills
  • Management skills, talent support and development
  • Excellent planning and organization abilities
  • High level of domain autonomy
Educational requirements
  • Master’s degree in Lifesciences, medical background preferred
  • Fluent in English (verbal and written)
  • Autonomous with MS Office (Word, Excel, PowerPoint, Teams)
Experience
  • Minimal 5 years biometrics or clinical project management position in medical device industry, biotech/pharma, CRO
  • Team management
  • Basic knowledge of database design, statistical software
  • Study reports
Apply Now

Intership: Supplier Quality Engineer (F/M)

Carmat

Job Category
Quality Assurance
Posted Date
Apr 3, 2023
Location
Bois-d'Arcy, Yvelines, France
Full Time
Intership: Supplier Quality Engineer (F/M)
Apply Now

Carmat

Job Category
Quality Assurance
Posted Date
Apr 3, 2023
Location
Bois-d'Arcy, Yvelines, France
Full Time

Job Description

CARMAT aims to respond to a major public health issue related to cardiovascular diseases, the main cause of death in the world: heart failure. Thanks to the continious development of its "total artificial heart", CARMAT aims to overcome the notorious lack of grafts that tens of thousands of people suffer from heart failure. To do so, the quality team is currently looking for a intern supplier quality engineer (F/M).

Missions
  • Ensure electronic components and coating’s conformity to Carmat’s specifications.
    • Establish the non-conformity (NC) problem statement
    • Direct the NC to the appropriate expert for analyze
    • Handle the whole NC process for specific cases
    • Be proactive and force of initiative in synchronizing with involved functions (industrialization, incoming and R&D)
  • Support suppliers performance improvement.
    • Monitor the defects occurrences within scope through appropriate metrics
    • Monitor the NC process through appropriate metrics
    • Establish appropriate reporting
  • Support the Supplier Quality Engineers in defining / implementing improvement plans.

NB. Main interactions: Purchasing, Production/Incoming and R&D.

Knowledge and skills
  • Problem solving oriented
  • Excel (know-how)
  • Autonomous
  • ISO9001 or ISO13485 (notions)
  • English (school level)
Required profile
  • BAC+4/+5, student in electronics engineering school (ESIEE, ENSEA, ESIGELEC)
  • Experience in data base treatment and associated relevant charts. Experience in problem solving. Ideally a first internship on similar scope in medical industry.
Futher information

Training period: 6 Months

Begining: ASAP

Location

Bois d’Arcy with some trips at Vélizy or at Suppliers sites

Apply Now

Commodity Buyer (M/F)

Carmat

Job Category
Purchasing and Supply Chain
Posted Date
Jan 30, 2023
Location
Bois-d'Arcy, Yvelines, France
Full Time
Commodity Buyer (M/F)
Apply Now

Carmat

Job Category
Purchasing and Supply Chain
Posted Date
Jan 30, 2023
Location
Bois-d'Arcy, Yvelines, France
Full Time

Job Description

CARMAT aims to respond to a major public health issue related to cardiovascular diseases, the main cause of death in the world: heart failure. Thanks to the continuous development of its "total artificial heart", CARMAT aims to overcome the notorious lack of grafts that tens of thousands of people suffer from heart failure. To do so, the Purchasing team is currently looking for a Commodity Buyer (M/F).

What you will do
  • Manage suppliers portfolio:
  • Managing the customer-supplier relationship
  • Develop and drive Sourcing strategies
  • Reduce risk by contracting with strategic suppliers
  • Capture supplier opportunities to influence internal customer needs
  • Monitor purchasing budget of its portfolio, alert on deviations, analyze discrepancies and propose corrective actions
  • Deploy cost reduction activities to contribute to the company’s profitability objective by 2027
  • Participate and develop purchasing culture with others internal departments
  • Ensure all operations of the purchasing process (benchmark, request for instruction, request for quotation, selection, negotiation, contracting and monitore the performance)
  • Support Team activities aimed at continuous improvement
  • Participate in the creation and implementation of digital tools & KPIs to monitor purchasing activities and performance
Qualifications & Experience:
  • 5+ years relevant working experience in multiple direct procurement categories or supply chain with an international scope
  • Master’s degree and/or Certified Purchasing Manager (or equivalent)
  • Good understanding of procurement / strategic commodity management preferred
  • Capability to manage multiple priorities in a fast-paced environment
  • Active working behavior to suppliers (dare to ask and discuss)
  • You are fluent in French and English
What do we offer you in return?

Team Spirit, Engagement, Diversity & Inclusion – our team is energetic, engaged and has a lot of potential. We create inclusive teams that encourage colleagues to share their diverse perspectives and opinions.

Flat hierarchies and responsibility – through flat hierarchies, we strengthen the initiative and willingness of our employees to take over responsible tasks.

Recognition of your Performance – at Carmat, outstanding individual and cross-functional team performance is well-know.

Apply Now