Sr. Engineer, Development

Sr. Engineer, Development

The Sr. Engineer, Development is responsible for leading and overseeing Development 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 high level of independence. 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 Sr. Engineer, Development is expected to have a high level of proficiency in Design Control and development methods, manufacturing methods, medical device regulations, and project management. They will be expected to successfully carry out and support complex project deliverables/Development functions with a focus on quality, compliance, and customer satisfaction.

May be responsible for the management of direct reports. Is seen as a leader and Subject Matter Expert within the Development team.

Principal Responsibilities:

• Apply complex project management principles to plan, lead and execute projects of low to high complexity independently.
• Lead quoting exercises such as component sourcing, identification of project deliverables and risks, and timeline estimation, of low to high complexity independently.
• 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 subject matter expert (SME) in design control and product capabilities to effectively lead and support Performance Fibers projects and initiatives.
• Work on complex, high impact, issues and challenges where broad holistic analysis of a situation or data is required.
• Establish new and/or improved processed based on changing regulations, or remedial activities to ensure compliance with regulatory and Quality System requirements.
• Ensure Teleflex Medical OEM suture products meet customer and quality system requirements.
• Provide technical leadership, lead root cause analysis, NC's, CAPA's and customer or project related problem resolution activities; materials, assembly, functional, or manufacturing related.
• Understand design control requirements and identify strategies to achieve project and business goals with moderate guidance.
• Serve as Subject Matter Expert in Teleflex suture products.
• Generate validation and verification protocols/reports, draft and review product labeling, initiate and manage sterility and biocompatibility assessments as well as other design control related documents independently.
• Provide guidance and leadership in Development and other cross functional groups on development and/or business practices.
• Effectively establish validation and development plans of high complexity, independently.
• Utilize methods of Lean/6σ and other continuous improvement methods for factory improvement programs such as Enterprise Excellence.
• Ensure Teleflex Medical OEM suture products meet customer and quality system requirements.
• Coordinate and support proper creation and maintenance of drawings, procedures, design documents (DFMEA, FMEA, Traceability Matrix, etc) as well as other technical and manufacturing documentation.
• Assist in developing strategies for growth of Development team and/or capabilities.
• Can act independently to establish new processes, method and techniques.
• Ensure projects are developed and documented compliant with the Quality System.
• Collaborate to develop quality…