Job Description
We are seeking an experienced Electronics Engineer to lead sourcing and validation of alternative components, support audit and compliance led projects, and design, prototype, and commission test equipment and fixtures. The ideal candidate will have a degree in Electronic/Mechatronic Engineering, 5+ years of relevant experience, and strong working knowledge of ISO 13485 and 21 CFR820. Key responsibilities include managing the introduction of technology on lines, modifications, and process improvements, developing process and test method validation protocols, and ensuring that process validations and work methods are adequate to maintain the highest quality standards. The role requires strong leadership and technical skills, with the ability to analyze complex situations, implement solutions, and develop new systems, procedures, or processes. **Key Responsibilities:** • Lead sourcing and validation of alternative components in support of LCM activities within the department for our patient critical products. • Support audit and compliance led projects for electro-mechanical assemblies and products. • Design, prototype, and commission test equipment and fixtures. • Manage health and safety aspects of test equipment and provide user training. • Support other departments as required. **Requirements:** • Degree in Electronic/Mechatronic Engineering. • 5+ years of relevant experience. • Strong working knowledge of ISO 13485 and 21 CFR820. • Strong leadership and technical skills. • Ability to analyze complex situations, implement solutions, and develop new systems, procedures, or processes. **Personal Competencies:** • Pro-active with proven ability to work under own initiative. • Strong team player. • Excellent planning and organizational skills. • Good interpersonal and communication skills.