Product Development Scientist Medical Devices

3 weken geleden

Utrecht, Nederland Oxford Global Resources Voltijd

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 14971).
  • 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./PhD 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 14971).
  • 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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