Development Engineer

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.

• 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.