Job Description
Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes. ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily: 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. Write, manage and maintain production test specifications and related work instructions for all sub-assemblies and products. Design, prototype, procurement, commissioning, and documentation of test equipment, and fixtures. Manage health and safety aspects of test equipment and provide user training. Support other departments as required, e.g. assist in analysis of customer returns, debug, root cause analysis, technical support for customers, conduct tests in the Test Laboratory, etc. Liaise with Product Development to provide DFT (Design For Test) inputs at an early stage in product design. Effectively manage the introduction of technology on lines, modifications and process improvements. Actively contribute to the enhancement of compliance initiatives for areas of responsibility. Develop strong links with our sister plants to ensure effective ongoing transfer and sharing of products, processes and systems. In response to in-house quality levels and product complaints, develop process improvement projects to achieve the highest quality standards. Generate Process and Test method validation protocols and reports. Ensure that process validations and work methods are adequate to maintain the highest quality standards. Provide technical support in field related activities such as clinical programmes and complaint investigations. Provide technical leadership and a structured approach to problem solving for operations personnel involved in process engineering and development activities. Present, where appropriate, technical data to internal / external audit and inspection groups as required. Provide ongoing technical guidance to lead professional work teams, conduct special projects. Identify complex problems and their impact on functional objectives. Analyse situations, implement solutions, and develop new systems, procedures or processes. Utilise expertise to directly influence other outside departments. QUALIFICATIONS / EXPERIENCE The requirements listed below are representative of the knowledge, skill, and/or ability required for this position: Degree in Electronic / Mechatronic Engineering, with minimal 5 years relevant experience. Familiar with electronic and electro-mechanical systems design and debug. A general knowledge of PCs (DOS, Windows, hardware installation). Capabilities in both analog and digital electronics. Willing to innovate and propose initiatives for new developments and continuous improvements. Basic mechanical aptitude for working with test fixtures and small assemblies. Fluent written and spoken English with excellent record keeping and report writing skills. Key Competencies Required Strong working knowledge of ISO 13485 and 21CFR820. Strong working knowledge of electrical safety, 60601 testing standards and compliance requirements. Effectively manage the introduction of technology on lines, modifications, and process improvements. Technical competency in reading schematics. Computer literacy, in particular electronic design applications. Analyse complex and new situations, anticipate problems or opportunities, assess impacts / risks. Develop and implement solutions. Guide and mentor other professionals. Adapt to negotiate with peers for common agreement. Influence others (departments & management). Willingness to travel to other Integra sites as part of duties. 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. Ability to lead cross-functional teams both onsite and remotely. MS Office, including MS Project. #J-18808-Ljbffr