Staff Engineer, Operations Integrator
Company: Edwards Lifesciences
Posted on: January 13, 2019
The Operations (Ops) Integrator Engineer will contribute to the development and commercialization of new products and the development of manufacturing process associated with novel medical devices and device improvements across Edwards's Critical Care Business. You will also serve as a subject matter expert to lead, develop and implement the technology/design transfer strategy of new products from the Critical Care product portfolio.
The Ops Integrator Engineer will report into the Critical Care Global Supply Chain Operations organization. You will serve as a key role in the project NPD team and will work closely with the cross-functional groups to ensure that the device design adheres to principles of DFM, adequate transfer of design requirements to the manufacturing site, development & validation of processes, compliance with Quality and Regulatory requirements, and manufacturing scalability. Additionally, the Ops Integrator Engineer will also be responsible for setting up product configurations, coordinating between the project team and the manufacturing sites, existing supplier base, supply chain, and developing product phase-in/phase-out strategies.
- Develop strategies and lead the operations integration efforts to execute and implement deliverables necessary for design/technology transfers
- Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) on new or existing product lines to qualify and validate manufacturing processes, analyze results, make recommendations, and develop reports
- Effectively communicate and influence the outcome of a deliverable requirements/objectives in a high energy, cross-functional team and multi-site environment that includes R&D, Regulatory, Quality, Procurement, Supply Chain, Supplier Quality/Development and Manufacturing/Operations
- Lead in the identification and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards
- Oversee manufacturing support tasks; give instruction to engineers/ technicians on conducting tests; train engineers/ technicians and provide feedback; and coordinate engineer/ technician work
- Lead and establish complex project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
- Analyze and resolve complex Manufacturing and Compliance issues (e.g. technical issues, non-conformances, etc.)
- Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
- Continuously improve existing product design, materials, manufacturability and sustainability
- Train, coach, and guide lower level employees on more complex procedures
- Be the subject matter expert in key disciplines related to the manufacture of Class I, II and III medical devices#LI-PJ1
Required Skills & Experience:
- Bachelor's degree in engineering discipline is required, preferably Mechanical, Electrical, Materials, or Biomedical Engineering.
- Six years of experience in the medical device industry.
- Experience in leading and served in a technical role for Design or Technology transfer
- Demonstrated use of process excellence methodologies and applied statistics / six-sigma methodologies
- Extensive understanding of materials, processes and equipment used in assigned work (e.g. Plastics, Adhesive bonding (Solvent and UV), Molding, Extrusion, Welding, Sterilization, Soldering, PCBA manufacturing)
- Knowledge of cGMP, EHS guidelines, FDA guidelines, Supplier Quality, Test Method Validations and Process Validation (IQ/OQ/PQ)
- Proven expertise in usage of MS Office Suite; CAD experience preferred
- Excellent documentation and communication skills and interpersonal relationship skills including negotiation skills
- Ability to articulate and translate technical information to all levels of the organizations
- Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering
- Advanced problem-solving, organizational, analytical and critical thinking skills
- Strong leadership skills and ability to influence change
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including frequent inter-organizational and contacts
- Represents organization in providing solutions to difficult technical issues associated with
Keywords: Edwards Lifesciences, Irvine , Staff Engineer, Operations Integrator, Engineering , Irvine, California
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