Staff Engineer

BD-posted 4 months ago
Full-time • Senior
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With direction from the GIE PPD Leader for UCC, the incumbent shall provide a leading Product & Process Design role in planning and execution of medical device projects for the Urology and Critical Care (UCC) Business Unit. They shall provide product design feedback and be the assembly subject matter expert (SME) for cross functional teams as applicable. In this capacity, the incumbent must be capable of specifying process technology, maintain timelines, associated project budgets and actively de-risk all aspects for the product and process development. This role will require regular updates to the supporting management, cross-function teams(s) and BU Operational leadership. This position will require 25% travel that can be unevenly distributed throughout the year and can exceed 25% when business requirements are needed.

  • Define manufacturing technology strategy for new products, support product design by manufacturability analysis of the devices and their packaging and ensure a successful transfer to the production floor.
  • Lead engineering efforts to build pilot lines of new manufacturing processes to attain process capability and OEE.
  • Responsible for working with R&D across UCC on the design and development of current and new products.
  • Perform DFA (Design For Assembly) and DFSS (Design For Six Sigma) analysis and establish assembly requirements and implement process controls to ensure product quality and consistency.
  • Guide in design for manufacturability & assembly principles.
  • Define manufacturing technology strategy for new products (NPD) and product design changes, influence product design through design for manufacture & assembly (DFMA) analysis and enable successful industrialization (internal or external) and transfer to the factories.
  • Ensure the assembly process is understood well to minimize risk.
  • Develop and implement assembly risk mitigation plans.
  • Ensure execution of DFMA efforts will lead to achieving COGS/GP targets in business case.
  • Support the development of DFMA standards and best practices for the Product Manufacturability and Assembly Design GIE team.
  • Collect the opportunities for existing manufacturing processes and identify areas for improvement.
  • Design new manufacturing processes that are efficient, within the targeted CapEx & COGS, and scalable.
  • Suggest alternative design iterations, exploring various form factors, materials, functional solutions to address user needs and manufacturing constraints.
  • Support process validations to ensure compliance with regulatory requirements.
  • Collaborate multi-functionally, especially with R&D and manufacturing specialists to ensure the design aligns with product requirements, and product designs are optimized for manufacturability, assembly, and overall performance.
  • SME in DFMA, engineering, and process for assembly.
  • Review and revise detailed CAD models of product designs, ensuring accuracy/alignment to specifications, standards and manufacturing requirements.
  • Participate in design verification/testing activities.
  • Present sophisticated data in a clear and concise manner to all levels of the organization.
  • Align with all local, state, federal, and BD safety laws, policies, and procedures.
  • Align with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
  • Provide technical leadership in the concept development of design control documentation.
  • Work both independently and/or collectively to develop project plans and execution of prioritizing and scheduling assignments to meet business goals.
  • Lead technical process reviews.
  • Work with design team to ensure components/assemblies are designed for manufacturability/excellence (DFM/DFx).
  • Plan, coordinate and lead all technical activities associated with commercialization and launch of new products including: Conceptualization and development of all manufacturing processes and methods.
  • Coordinate all development and manufacturing of new tooling and equipment.
  • Support makes vs buy analysis and identifying new vendors.
  • Support site selection activities.
  • Coordinate and support all new vendor equipment, tooling, molds, etc.
  • Support development of all products and process documentation.
  • Support in-process test and/or inspection procedure development.
  • Plan, order and manage component inventory.
  • Perform process characterization of all new operations and processes.
  • Develop, implement, analyze, and write reports for validation protocols.
  • Develop new product cost estimates.
  • Support preparation of capital equipment requisitions (CB2).
  • Evaluate and recommend new materials.
  • BS degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or equivalent required.
  • Min 10 years’ experience or eight (8) years’ with MS degree.
  • 5+ years of experience in advanced manufacturing engineering, product design, and/or technical leadership level in Medical Device or other highly regulated industries.
  • 5+ years of professional experience in mechanical design, with a significant and demonstrable focus on applying DFMA principles.
  • Demonstrated experience leading/deploying Advanced Manufacturing initiatives.
  • Digitalization and automation experience / exposure required.
  • Sound capability to understand concepts and approaches in facilitating strong leadership expected.
  • Experience in process validation, writing protocols and reports to support verification and validation activities for product commercialization.
  • Intermediate/Advanced knowledge of design and simulation software’s such as SolidWorks, AutoCAD, ProModel, FlexSim.
  • Ability to build and implement project plans.
  • Basic tooling, design and drafting knowledge.
  • Ability to analyze data, interpret results, and write reports.
  • Proficient in statistical software.
  • Experience with both manual and semi-automated production lines preferred.
  • Excellent technical skills including project management, organization, planning, and capital budgets.
  • Excellent Interpersonal Skills - able to express ideas and collaborate optimally with multidisciplinary teams.
  • Ability to work with minimal guidance, conceptualize ideas, motivate, and focus individuals and teams and drive projects through completion on time and on budget.
  • Understanding and ability to implement DOEs, process characterizations and validations using standard statistical techniques.
  • Understanding of GMPs and medical device regulations as they apply to manufacturing.
  • Ability to interpret, edit and correct part drawings.
  • Understanding of GD&T.
  • Risk analysis / FMEA.
  • Understanding of project management and budgeting.
  • Preferred: MBA or MS in Engineering.
  • On-site collaboration to foster creativity and innovation.
  • Work-life balance with flexibility.
  • Career development opportunities.
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