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    Product Development Scientist Medical Devices - Utrecht, Nederland - Oxford Global Resources

    Oxford Global Resources
    Oxford Global Resources Utrecht, Nederland

    3 dagen geleden

    Oxford Global Resources background
    Voltijd
    Beschrijving
    We are looking for passionate product developer within medical divides.

    You well work on developing cutting-edge solutions utilizing synthetic bioresorbable materials and therapeutic proteins.

    Job Description:

    We are seeking a talented and motivated Product Development Scientist with expertise in medical devices to join our dynamic team.


    As a Product Development Scientist, you will play a pivotal role in the advancement of our product portfolio, ensuring regulatory compliance and driving innovation in orthopaedic medical devices.


    You will lead cross-functional teams, manage project time lines, and contribute to the development of high-quality products from concept to market launch.


    Responsibilities :
    Lead product development initiatives in accordance with regulatory requirements within the medical device industry.

    Collaborate with cross-functional teams to achieve project milestones and deliver innovative solutions that meet customer needs.

    Manage project time lines, budgets, and resources effectively to ensure successful product development and commercialisation.

    Conduct Verification & Validation studies, optimise processes for efficient production transfer, and maintain regulatory documentation.

    Design, execute, and analyse laboratory experiments to support product development activities.

    Manage process to ensure compliance with regulatory standards (ISO 13485, ISO 10993, ISO

    Perform risk assessment and mitigation strategies for product design, usability, and safety.

    Oversee process verification and validation activities, including design transfer to GMP manufacturing.

    Conduct preclinical and clinical evaluations, including literature reviews, clinical strategy development, and bio-compatibility assessments.

    Develop statistical sampling plans and testing protocols to ensure product quality and performance.

    Review, assess, and revalidate quality assurance and regulatory affairs documents.

    Investigate root causes of manufacturing issues and non-conformities, implementing corrective and preventive actions (CAPA) as needed.

    Provide scientific support to marketing and production departments to drive business objectives.

    Requirements :

    Minimum Education:
    MSc./Ph D in a relevant scientific or engineering field.

    Proven experience in product development for medical devices, preferably in orthopaedics.

    Familiarity with medical device registration processes, including 510(k) clearance and regulatory standards (ISO 13485, ISO 10993, ISO

    Strong project management skills with the ability to lead cross-functional teams and drive projects to successful completion.

    Experience in conducting laboratory experiments, data analysis, and interpreting results.

    Excellent communication skills with the ability to collaborate effectively with internal and external stakeholders.

    Ability to think creatively and propose innovative solutions to complex technical challenges.

    Detail-oriented with a strong focus on quality and regulatory compliance.

    Demonstrated ability to work independently and as part of a team in a fast-paced environment.

    Fluency in English, both written and spoken.

    Benefits :
    Competitive salary range

    Contract Type:
    Permanent
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