Systems Engineer (Medical Devices) – Limerick
A fantastic opportunity for a Systems Engineer with a strong history in medical device design and regulatory compliance.
- Demonstrate knowledge of advanced system-level medical device technology and R&D development process.
- Demonstrate detailed knowledge of medical product design process.
- Coordinating and influence product development across multiple disciplines.
- Serve as a key resource to examine product behavior issues and bring to resolution.
- Provide technical support to a wide range of engineering problems.
- Assures deep technical understanding of infusion products.
- Drive technical excellence and design decisions throughout the organization.
- Identify technical risks early and establish mitigation options and track resolution.
- Developing and sustaining productive business relationships.
- Setting high goals for personal and group accomplishment.
- Establishing courses of action and plans to ensure that work is completed efficiently.
- BSc. in biomedical, mechatronics, mechanical, electrical, electronics, software or systems engineering.
- 5+ years’ overall experience in the medical industry.
- Ability to support Regulatory Affairs with engineering input for design.
- Completion of risk benefit analysis documentation.
- Maintain technical risk management files for existing devices and take input from Clinical Evidence Reports.
- Knowledge of MDR/MDD/AIMD, global medical device/FDA regulations, ISO 14971, ISO 13485, EN/IEC 60601, device remediation, UDI & device traceability, Sterilization, Material Biocompatibility, and Clinical Trials advantageous.
- Experience working within formal medical QMS processes and system tools advantageous.
- Experience in DFSS (Design for Six Sigma) advantageous.
- Experience with formal Requirements Management and document configuration tools advantageous.
- Strong technical writing skills, producing requirements specifications, risk reports, and test procedures.
- Must be authorised to work in Ireland.
Please contact Emer Moore to discuss in confidence