Senior Medical Device Project Lead

4 weken geleden

Eindhoven, Noord-Brabant, Nederland Onera Health Voltijd
Job Description

Onera Health is a pioneer in transforming sleep medicine and remote monitoring. We offer a unique opportunity for professional growth in an ambitious and fast-growing start-up.

About Onera Health

We are a leader in developing breakthrough diagnostic solutions and services to help millions of people struggling with sleep-related ailments, while also impacting other medical fields by monitoring various chronic conditions, ultimately improving the health and quality of life for patients worldwide.

Key Responsibilities

  • Project Planning and Initiation
    • Define project scope, objectives, and deliverables that support business goals in collaboration with senior management and stakeholders.
    • Develop comprehensive project plans that include timelines, resources, budget, and risk management strategies.
    • Ensure that project plans comply with our QMS and applicable regulatory standards.
  • Quality and Compliance
    • Ensure that all project deliverables meet quality standards and regulatory requirements.
    • Work closely with the quality assurance team to integrate quality controls into the project workflow.
    • Manage the Design History File (DHF) and ensure all design controls are implemented.
    • Contributes in audits, ensuring availability of supporting evidence in timely manner.
  • Project Execution and Monitoring
    • Lead project teams to ensure timely and effective execution of project tasks.
    • Monitor project progress against the plan, adjusting as needed to address deviations.
    • Ensure all project activities and changes are documented, reviewed and approved in compliance with our QMS and maintain accurate project records.
    • Manage changes to project scope, schedule, and costs using appropriate verification techniques.
  • Stakeholder Management, Communication and Reporting
    • Serve as the primary point of contact for project stakeholders, providing regular updates on project status, risks, and issues.
    • Prepare and present project reports, including progress updates, risk assessments, and project outcomes to senior management and regulatory bodies.
    • Monitor and manage project risks throughout the project lifecycle, implementing corrective actions as necessary.
  • Resource Management
    • Ensure product resource needs are met, including personnel, equipment, and materials.
    • Coordinate with cross-functional teams, including R&D, quality assurance, regulatory affairs, production, and marketing.
    • Coaching and advising project team members.

Requirements

  • Min. Bsc in technical field (Computer Science, Engineering, life sciences, business administration etc.)
  • A master's degree in a relevant discipline, such as biomedical engineering, project management, or an MBA, can be advantageous.
  • Experience with project management related to (medical) device product development (SW, HW, System)
  • Knowledge of project management methodologies and tools (PMP, Agile, Jira)
  • Understanding of ISO 13485 and knowledge of other relevant medical regulations (e.g., FDA, MDR, IVDR), as well as IEC 62304 and IEC 60601 requirements, is a plus
  • Proficiency in risk management principles and practices, esp. ISO14971
  • Strong leadership skills with the ability to motivate and manage teams and excellent conflict resolution and negotiation skills
  • Decision-making and problem-solving skills (analyze complex problems, identify root causes, implement effective solutions)
  • Excellent interpersonal and communication skills
  • Strong focus on quality assurance and compliance
  • Excellent organizational skills with the ability to manage multiple priorities and projects simultaneously. Strong attention to detail and ability to meet deadlines
  • Proficiency in project documentation and record-keeping in compliance with regulatory standards
  • Ability to prepare clear and concise reports for various stakeholders
  • Pro-active and focused on results with strong sense of responsibility and accountability

Benefits

We offer:

  • Opportunity to work on cutting-edge medical device technology.
  • Collaborative and innovative work environment.
  • Competitive salary: €80,000 - €100,000 per year, depending on experience.
  • Professional growth and development opportunities.
  • Technical equipment to set up a home office.

  • Signal Processing Engineer

    4 weken geleden

    Eindhoven, Noord-Brabant, Nederland Onera Health Voltijd

    About Onera HealthWe are a leading provider of breakthrough diagnostic solutions and services that empower healthcare providers with comprehensive data to optimize patient care and reduce healthcare costs.Job OverviewThis role offers the opportunity to contribute to the design and development of cutting-edge medical device technology, collaborating with...

  • Senior Data Scientist

    1 week geleden

    Eindhoven, Noord-Brabant, Nederland TU Eindhoven Voltijd

    Job Title: Senior Data Scientist - Cardiac Health and Medical ResearchCompany Overview:The Electronic Systems group at TU Eindhoven is a world-renowned research institution that focuses on design automation and embedded systems. We are seeking an exceptional Senior Data Scientist to join our team and contribute to our mission of creating innovative solutions...

  • Operational Excellence Lead for Medical Devices

    2 weken geleden

    Eindhoven, Noord-Brabant, Nederland Philips Voltijd

    Job OverviewWe are seeking an experienced Operational Excellence Lead to join our team at Philips in the Netherlands. In this role, you will lead the production team of the Micro-Devices department, driving operational excellence and manufacturing medical and non-medical devices, PCBA's and components in a safe, compliant, and effective manner.

  • Diagnostic Project Manager

    3 weken geleden

    Eindhoven, Noord-Brabant, Nederland ShanX Medtech BV Voltijd

    Role OverviewWe are seeking a highly skilled Diagnostic Project Manager to lead the development of our groundbreaking rapid antibiotic susceptibility testing device, KAIROS IVD.Key ResponsibilitiesDevelop and execute comprehensive project plans, timelines, and budgets to ensure alignment with company goals and objectives.Lead cross-functional project teams,...

  • Diagnostic Project Coordinator

    2 dagen geleden

    Eindhoven, Noord-Brabant, Nederland ShanX Medtech BV Voltijd

    ShanX Medtech BV, a pioneering company in the field of in-vitro diagnostics, is seeking an exceptional Diagnostic Project Coordinator to drive the successful execution of its groundbreaking rapid antibiotic susceptibility testing device, KAIROS IVD.Focused on transforming infection management, our mission is to equip healthcare professionals with the means...

  • Senior Technical Program Lead

    4 weken geleden

    Eindhoven, Noord-Brabant, Nederland TMC Voltijd

    About This OpportunityAs a Senior Technical Program Lead at TMC, you will be responsible for leading R&D projects and teams through the entire product development cycle. Your primary goal is to translate client specifications into clear project scopes, mitigate risks early on, define project plans and budgets, and execute them successfully.Key...

  • Project Manager

    2 maanden geleden

    Eindhoven, Noord-Brabant, Noord-Brabant, Nederland Brunel Voltijd

    Are you ready to lead innovative projects in the field of cutting-edge X-ray technology? We are partnering with a leading global technology company that specializes in the design and manufacture of high-performance X-ray detectors for medical, dental, and industrial applications. Our client is renow

  • Senior Test Coordinator for Engine Projects

    3 weken geleden

    Eindhoven, Noord-Brabant, Nederland Yacht. Voltijd

    At Yacht, we are seeking a highly skilled Senior Test Coordinator to join our team of professionals dedicated to ensuring the highest standards of engine performance and quality. As a key member of our Functional Testing Team, you will play a crucial role in coordinating the activities of our on-site test engineers, working on current and future development...

  • Industrialization Project Lead

    1 week geleden

    Eindhoven, Noord-Brabant, Nederland TMC Voltijd

    About This RoleWe are seeking a skilled Industrialization Project Lead to join our team in Eindhoven. As an Industrialization Project Lead, you will be responsible for leading complex projects from engineering to production, ensuring seamless industrialization and on-time delivery.Key ResponsibilitiesDefine project scope, plan, and budget to meet client...

  • Industrialization Project Lead

    4 weken geleden

    Eindhoven, Noord-Brabant, Nederland TMC Voltijd

    About this OpportunityWe are seeking an experienced Project Manager NPI to join our team at TMC. As a seasoned professional in new product introduction, you will lead complex projects from engineering to production.Job DescriptionThis is a challenging role for individuals who thrive in fast-paced environments and enjoy working with diverse stakeholders. You...

  • Senior project manager re-use

    1 maand geleden

    Eindhoven, Noord-Brabant, Nederland ASML Voltijd

    Introduction to the jobAs Senior project lead re-use, you become part of the Reverse Supply Chain Management team of the Repair and Reuse (R&R) organization of ASML. For this role we are looking for a Senior project manager with a green heart to support us by leading and driving key projects to implement new processes or process improvements that enable the...

  • Sustainable Technology Project Lead

    1 maand geleden

    Eindhoven, Noord-Brabant, Nederland TMC Voltijd

    We are seeking a skilled project lead to join our team at TMC, a global high-tech consultancy firm.About the RoleThis is a challenging opportunity for a seasoned professional to drive complex projects focused on sustainable technology solutions. As a project lead, you will be responsible for overseeing the execution of various initiatives, ensuring timely...

  • Technical Project Lead for Sustainable Innovations

    2 weken geleden

    Eindhoven, Noord-Brabant, Nederland TMC Voltijd

    Job Title: Technical Project Lead for Sustainable Innovations About the Company:TMC is a global high-tech consultancy firm that supports clients with their technological challenges. We function as an expert center, aiding clients in becoming more competitive in a rapidly evolving technological landscape. Role Overview:We are seeking a driven project...

  • Technical Lead

    2 weken geleden

    Eindhoven, Noord-Brabant, Nederland TMC Voltijd

    About the RoleWe are seeking a seasoned Technical Lead to oversee the implementation of R&D projects from concept design to release. The ideal candidate will possess excellent leadership and communication skills, with a proven track record in managing cross-functional teams.ResponsibilitiesTranslate client specifications into clear project scopes and...

  • Innovative Project Lead for Diagnostic Solutions

    2 weken geleden

    Eindhoven, Noord-Brabant, Nederland ShanX Medtech BV Voltijd

    Company OverviewShanX Medtech BV is a pioneering young company that aims to revolutionize the healthcare industry through innovative diagnostic tools. Our journey began with a deeply personal experience that ignited our mission to transform infection management.Salary and BenefitsThe estimated salary for this part-time contract (24 hours per week) extending...

  • Lead Metrology Process Specialist

    1 week geleden

    Eindhoven, Noord-Brabant, Nederland Yacht Voltijd

    Senior Metrology Process Engineer at YachtJob Description:We are seeking a skilled Senior Metrology Process Engineer to lead and work on process engineering and development projects for integrated thin film applications, products, and processes.Key Responsibilities:Develop and implement measurement methods to support manufacturing and design areas.Analyze...

  • Senior Software Engineer for fMRI Educational Platform

    4 weken geleden

    Eindhoven, Noord-Brabant, Nederland TU Eindhoven Voltijd

    Welcome to this exciting opportunity at the Eindhoven University of Technology (TU/e)!We are seeking a highly skilled Senior Software Engineer to join our team and contribute to the development of an innovative fMRI educational software platform.About the JobThis is a unique chance to work on a cutting-edge project that combines advanced signal processing...

  • Senior Technical Lead

    3 weken geleden

    Eindhoven, Noord-Brabant, Nederland Thermo Fisher Scientific Voltijd

    At Thermo Fisher Scientific, we are the world leader in serving science. With annual revenue exceeding $40 billion, our mission is to enable customers to make the world healthier, cleaner and safer.We develop software solutions that control and calibrate hardware components for users of our Transmission Electron Microscope (TEM) products. As a Senior...

  • Production Leader for Electronics Manufacturing

    2 weken geleden

    Eindhoven, Noord-Brabant, Nederland Philips Voltijd

    Seeking a highly skilled Production Manager to lead our Micro Devices team in Eindhoven, Netherlands. This is an onsite role requiring full-time presence at our facilities.About the RoleWe are looking for a seasoned professional with minimum 6 years of experience in operations or supply chain management. You will be responsible for driving operational...

  • Senior High Tech Product Development Specialist

    2 weken geleden

    Eindhoven, Noord-Brabant, Nederland ICT Group Voltijd

    We are seeking a Senior High Tech Product Development Specialist to join our team at the ICT Group. In this role, you will work on various assignments and projects in domains such as medical and high-tech equipment.About UsThe ICT Group is a leading provider of innovative solutions for the high-tech industry. Our team consists of experienced professionals...