INGENYX - Engineer III, Development

Engineer III, Development

The Engineer III, Development is responsible for leading the execution and oversight of engineering projects of varying complexity within the OEM Performance Fibers (sutures) business unit. With a focus on new development projects such as sterile and non-sterile line extensions, new suture constructs, processes and technologies, they are responsible for leading and supporting Development projects with a low level of guidance.

They are also responsible for establishing and supporting manufacturing operations including the validation of new equipment and materials, troubleshooting development processes, as well as identifying and implementing process/product improvements within development activities.

The engineer will work with cross-functional teams to resolve material issues, customer complaints, design and develop new product, and review potential new business opportunities. The Engineer III, Development is expected to have a working proficiency in Design Control and development methods, medical device regulations, manufacturing, and project management. They will be expected to successfully carry out and support project deliverables/product development functions with a focus on quality, compliance, and customer needs.

The scope of products for which the Engineer III, Development will be primarily responsible for developing and supporting includes sterile and non-sterile suture components, contract manufactured suture products, and sterile suture devices for the Mansfield, MA, Coventry, CT, and Nuevo Laredo, MX facilities.

• Plan, lead and manage projects and manufacturing engineering activities of moderate to low complexity independently. Manage complex projects/programs with some guidance.
• Lead development of products that minimize/mitigate product and manufacturing variation, scrap rates, and productivity throughout the manufacturing process, from supplier management to distribution of product.
• Develop custom devices, sutures and subassemblies according to customer design, performance, and quality specifications; on time and within project constraints.
• Identify and manage the scope of projects with a good understanding of interdependencies.
• Draft and route project initiation/closure documents, identifying the required deliverables per local and global procedures, as well as governing regulations, with minimal guidance based on project complexity.
• Interface with cross functional teams to maintain accountability, coordinate and execute deliverables supporting new product and capability development projects, and other initiatives.
• Serve as central contributor to identification and execution of continuous improvement initiatives.
• Accurately predict project requirements, costs, lead times, and delivery schedules during the quoting and project execution processes.
• Apply structured project management principles such as scope definition, timeline development, contingency planning, risk planning and mitigation, stakeholder analysis, et cetera, to plan, lead and execute projects of low to high complexity.
• Lead quoting exercises such as component sourcing, identification of project deliverables and risks, and timeline estimation, of low to high complexity with minimal guidance.
• Review and prepare status reports, modify schedules, and project plans of high complexity as required.
• Manage stakeholder communication to ensure project status and/or related issues are effectively communicated. Collaborate with sales and customer care to support customer communications.
• Utilize and integrate lean principles within project, process, and resource management activities, acting as a catalyst for initiating change.
• Serve as key resource in design control and product capabilities to effectively lead and support Performance Fibers projects and initiatives.
• Ensure Teleflex Medical OEM suture products meet customer and quality system requirements.
• Provide technical leadership, lead root cause analysis and customer or project related problem resolution activities; materials, assembly, functional, or manufacturing related.
• Possess detailed understanding of design control requirements…