The process development staff manufacturing engineer will work under the Manufacturing Technology Innovation team to support manufacturing technology development for the Infusion Disposables Business. The Staff Engineer will plan, design and coordinate the implementation of manufacturing systems and related activities in any of the ISD manufacturing plants to support new product development as well as existing production. The Staff Engineer is responsible for the process development technology portion of the introduction of new products into production (DFM, manufacturing process design); provides expert engineering skill, judgment, and mentoring of other engineers; provides process development support to new product development and technology teams.
- Accountable for process development and manufacturing process design to meet worldwide Infusion Disposables business objectives. Work closely with Operations, R&D, Quality, Procurement and External Vendors to implement manufacturing technology.
- Lead and coordinate the development of new processes for manual through automated assembly by interfacing with personnel from R&D, product design/development, quality, operations, and assembly technology.
- Work closely with R&D, production plants and operations engineers during product design phase to provide feedback and define how the product will be assembled and meet the desired product performance while meeting business objectives.
- Develops capital and product cost analysis; writes and submits capital appropriations.
- Develops specifications and acceptance protocols for new processes or existing processes to purchase production equipment.
- Work in the design transfer of new products to assure seamlessly introduction of new technology and/or products into manufacturing plants.
- Specify and/or purchase equipment, tooling and fixtures for new processes, existing processes, or existing process changes.
- Install new equipment, tooling and fixtures to support new product development, existing manufacturing process changes, or replication. Responsible for documentation and training.
- Develop and implement new processes for pilot production and scale-up programs and ensure successful technology transfer.
- Applies six-sigma and lean manufacturing methodologies to ensure optimization of new and existing product lines.
- Initiate cost savings opportunities and supports external vendors in identifying and implementing cost reduction projects.
- Participate in the evaluation and assessment of new technologies, new materials, intellectual property, products, processes and industry trends that can or have the potential to impact our global business.
- Identify best-in-class industry equipment and work with vendors to develop partners and establish relationships.
- Utilize CAD/CAM, state-of-the art productivity tools and design machine fixtures and tools.
- Coordinate and carry out qualification and validation activities for new products/ processes as required.
- Participate on project teams at many levels – extended team, core team, and core team leadership. Supervise other engineers and technicians, as required, to complete assigned projects.
- Coach and mentor process engineers to identify opportunities to build capability within the MTI team and at production plants.
- Participate on project teams as a Core Team Member or Leader representing process development, assembly, packaging, and/or other engineering/technical/operations discipline.
- Coordinate and communicate assigned projects and their status with the appropriate personnel and departments.
- Work with the process development experts within BD to leverage internal technology knowledge in project execution.
- Participate in assigned career development training programs, including Validation Practitioner Green/Black Belt training.
- Comply with all local, state, federal, and BD safety regulations, policies, and procedures.
- Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
- Ability to clearly communicate ideas and knowledge (upward and downward) to other individuals and teams - both in writing and verbally.
- Other duties as assigned.
- Completion of Individual Impact Goals (IIGs) as assigned.
- Strong and clear accountability for the success of large, complex and sometimes multiple projects.
- Work conducted with engineering best practices – careful, deliberate, meticulous work that is well documented.
- Develops and maintains project plans and communicates effectively at all levels.
- Provides feedback and develops and mentors others.
- Delivery of new equipment and process development on time and as per planned budget.
- Delivery of project savings projects as per planned budget.
- Manages assigned projects, using advanced project management tools, providing tracking and regular updates of project plan and project budget.
Education and experience requirements:
- BS degree in Engineering, scientific discipline, or a related field, or sufficient on-the-job experience and high school diploma / GED
- At least ten years of broad experience in process development, manufacturing engineering, assembling equipment specification, technology transfer and assessment of product manufacturability.
- Ability to interpret, edit and correct part drawings.
- Experience working in a development environment, with an understanding of process design, process capability and manufacturing cost analysis.
- Medical device industry experiencepreferred.
- Experience developing processes for high volume manufacturing and NPI
- Strong analytical and empirical skills.
- Proficient in advanced tools for analytically modeling (such as Six Sigma certification).
- Must have strong interpersonal skills.
- Language: English – primary, Spanish – secondary (preferred)
- About 30% travelrequired (travel is primarily within driving distance, will be required to take day trips to our Brea design center and Tijuana manufacturing plant as needed.)\