Innofiber is a specialized technology company focused on the design, development, and manufacturing of advanced fiber optic cable assemblies for medical and industrial applications. Emphasizing innovation, quality, and regulatory compliance, we ensure our products meet the highest industry standards. We are looking for an Engineering Manager to join our team as we deliver reliable, high-performance fiber optic solutions that enhance medical and industrial technologies. The Engineering Manager will play a key role in driving our engineering efforts to ensure the successful design, development, and manufacturing of our products. This role is the Champion of our Kaizen culture and continuous improvement efforts on the production floor. You will be responsible for leading and managing engineering projects from conception to completion, ensuring compliance with regulatory standards and industry best practices. You will collaborate with cross-functional teams, including R&D, quality assurance, and manufacturing, to develop and optimize manufacturing processes, drive continuous improvement initiatives, and provide technical guidance to junior engineers. Key Responsibilities
Develop and implement robust manufacturing processes, ensuring the process designs are capable of meeting Customer TAKT, and ensuring process adherence to regulatory standards, quality guidelines, and best practices. Lead Kaizen workshops improving Innofiber's manufacturing and business processes. Drive continuous improvement initiatives to enhance product quality, reduce costs, and increase manufacturing efficiency. Foster a collaborative team environment, with a strong emphasis on cross-functional coordination, facilitating open communication, and effectively managing diverse engineering talents to drive project completion and achieve organizational goals. Collaborate with cross-functional teams to define project requirements, set goals, and establish project timelines including managing project scope with Innofiber's Commercials Sales team. Conduct feasibility studies and risk assessments to evaluate design concepts, process capabilities, and equipment requirements. Set up project milestone and design reviews, ensuring compliance with Customer requirements and regulatory requirements. Provide technical expertise and guidance to the Engineering team, troubleshooting and resolving complex engineering issues. Stay up to date with industry trends, emerging technologies, and regulatory changes relevant to medical device manufacturing. Prepare and manage appropriate revision controls for all technical documentation, including engineering specifications, manufacturing instructions, and validation protocols.
Qualifications/Experience/Education
Bachelor's or Master's degree in engineering (Mechanical, Electrical, or Biomedical Engineering preferred). A minimum of 5 years of experience in engineering leadership roles within the medical device manufacturing industry is preferred. Proficient in CAD software (SolidWorks is preferred) and other engineering tools. Proven experience in leading and managing engineering projects, from concept to commercialization. Effective communication skills with the ability to effectively present technical information.