Development Engineer
1 week ago
Unit 4D,
Western Business Park,
Shannon,
Co. Clare
Job Description
Job Summary
We are seeking a skilled and innovative Development Engineer to lead the development and implementation of medical device products in compliance with ISO 13485. This role involves driving the design, documentation, and validation of products throughout their lifecycle, ensuring regulatory compliance and high-quality standards.
Role and Responsibilities
1. Oversee the full product development process, from concept design to commercialization, ensuring compliance with ISO 13485 and other relevant regulations.
2. Document and maintain comprehensive design and development records to ensure traceability and compliance with regulatory requirements.
3. Collaborate with cross-functional teams to define product requirements, develop specifications, and ensure alignment with user needs and business goals.
4. Perform design verification and validation activities, including the development and execution of test protocols, data analysis, and reporting.
5. Conduct risk assessments and manage risk documentation in line with ISO 14971.
6. Support manufacturing teams in transitioning products from development to production, addressing design transfer challenges.
7. Stay informed about advancements in technology, regulatory changes, and industry best practices to enhance product development processes.
8. Lead problem-solving initiatives to address technical challenges and implement design improvements for existing products.
9. Ensure all health, safety and environmental requirements are met.
10. Responsible for the implementation of the quality system as it applies to the specific activities being performed.
11. Supports timely introduction of any new products or sustaining changes in the designated business area; including development of product costs (COGS).
12. Actively involved in sourcing, testing and approving materials.
13. Complies and analyses operational, test, and development data to establish performance standards for newly designed or modified products.
14. Creates and maintains design plans, design inputs, verification/validation protocols & reports according to design control procedures for design history file maintenance and creation.
15. Ensure compliance with medical device regulatory requirements, including FDA and ISO 13485 standards.
16. Provide guidance and mentorship to junior engineers and technicians, fostering a culture of continuous learning and professional growth.
17. Perform biocompatibility assessments in accordance to ISO 10993 for new product introductions/design changes and coordinate associated testing.
18. Performs other related duties as assigned by their supervisor.
Qualifications and Education Requirements
1. Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.
2. Demonstrated utilization of Design for Six Sigma, Design for Manufacture/Assembly and Design for Test methodologies highly desirable.
3. Minimum of 3-5 years of experience in medical device design and development, with a strong understanding of ISO 13485 requirements.
4. Proficiency in documenting design activities and managing product development records.
5. Qualifications or education with specialized knowledge of biomaterials is highly advantageous.
6. Strong knowledge of risk management principles and tools (e.g., FMEA).
7. Ability to manage multiple projects and prioritize workload effectively to meet project deadlines.
8. Excellent communication, interpersonal and presentation skills.
9. Strong technical acumen and ability to understand complex technical concepts/issues and develop practical solutions.
10. Strong attention to detail and ability to work meticulously to ensure accuracy in testing and documentation.
Note: This description reflects essential functions and does not prescribe nor restrict tasks that may be assigned.
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