Development Engineer (Medical Device)
CREGG are seeking a Development Engineer to lead the design, development, and validation of cutting-edge medical device products.
Brief Job Description
As a Development Engineer, you will manage the full product lifecycle, from concept to commercialisation. You will be responsible for product design, risk assessments, and documentation while collaborating with cross-functional teams to meet business and regulatory goals.
Roles and Responsibilities may include (but aren't limited to):
* Manage product development processes from concept design to commercialisation.
* Ensure compliance with ISO 13485, FDA, and other regulatory requirements.
* Maintain comprehensive design and development records.
* Conduct design verification and validation activities, including test protocol development, data analysis, and reporting.
* Perform risk assessments and manage documentation per ISO 14971.
* Collaborate with cross-functional teams to define product requirements and specifications.
* Provide technical support during product transfer to manufacturing.
* Lead problem-solving initiatives to address technical challenges and enhance product design.
* Conduct biocompatibility assessments (ISO 10993) and coordinate associated testing.
* Mentor junior engineers and technicians, fostering continuous learning.
* Ensure health, safety, and environmental compliance in all activities.
Qualifications/Skills Sought
* Bachelor’s or Master’s degree in Biomedical, Mechanical Engineering, or related fields.
* Minimum 3-5 years of experience in medical device design and development.
* Strong understanding of ISO 13485 requirements and regulatory compliance.
* Proficiency in documenting design activities and managing product development records.
* Experience with Design for Six Sigma, Design for Manufacture/Assembly, and Design for Test methodologies is highly desirable.
* Knowledge of risk management principles (e.g., FMEA).
* Familiarity with biomaterials is advantageous.
* Strong technical problem-solving skills.
* Ability to manage multiple projects and meet deadlines.
* Exceptional communication, interpersonal, and organisational skills.
Contact Information
For a confidential discussion about this opportunity, please contact Brendan at 086 1772 380 or email brendanmcmahon@cregg.ie
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