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 and coordinate associated testing.
Mentor junior engineers and technicians, fostering continuous learning.
Ensure health, safety, and environmental compliance in all activities.
Qualifications/Skills Sought Bachelors or Masters 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 or email Skills: Product Development NPI NPD ISO13485 FDA ISO14971
Validation Benefits:
Mobile phone Paid Holidays Canteen Parking VHI Pension Educational assistance