For our client, a leading biotech organization in antibacterial medical solutions, we are currently looking for a Product Development Engineer to join the expanding team.
Employment Type: Temporary with Potential for Permanent Employment
Location: Zürich, hybrid
Key Responsibilities:
* Lead the development of medical devices for wound care, focusing on antimicrobial, chemical, and physical properties.
* Ensure products meet safety and performance specifications compliant with clinical, regulatory, and market requirements.
* Conduct design review meetings to assess product feasibility, performance, and regulatory compliance.
* Collaborate with internal partners and stakeholders to drive project success and meet milestones.
* Prepare and review technical documentation for the product portfolio.
* Manage outsourced verification testing, ensuring adherence to ISO 13485 standards.
* Develop and monitor test setups and studies for new product developments.
* Participate in product risk assessment and management by regulatory guidelines.
* Support prototype manufacturing and production scale-up activities.
* Drive continuous improvement and refinement, collaborating with external partners for product excellence and innovation.
* Issue and review Standard Operating Procedures and processes within the designated area of responsibility.
Required Competencies:
* Master’s degree in a relevant field (e.g., chemistry, material science - preferably in polymer science and technology).
* 5+ years of experience in medical device development, with a strong understanding of product lifecycle management.
* Proficiency in medical device manufacturing processes, from prototype development to mass production scale-up.
* In-depth knowledge of quality management systems, including ISO 13485, ISO 14971, 21 CFR Part 820, and EU MDR requirements.
* Familiarity with regulatory requirements for EU and FDA registration of medical devices.
* Strong analytical and problem-solving skills, with attention to detail and accuracy.
* Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
* Experience in managing communication and collaboration with external CROs, CDMOs, and academic institutions.
Join the team and contribute to the development of cutting-edge medical devices that make a difference in patients' lives. Apply now to be part of the innovative and dynamic organization!
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