Engineer III (Materials) -Laser Center of Excellence, Salem VA
The Engineer III will be responsible for translating business needs into technical solutions across a variety of vascular device platforms. Specifically, the incumbent will lead the development of post-processing (heat treatment, acid cleaning, electropolishing, etc.) in Integer's Salem Laser Center of Excellence which is focused on the application of laser processing in the productions of medical devices. The engineering role performs assignments involving considerable responsibility including: development of chemical and thermal processes for the manufacture of medical components and sub-assemblies, development of specifications, analysis of engineering problems and demonstration of process compliance through verification and validation activities. The role requires close collaboration with Operations, Engineering, R&D, Customers, Management, and Quality throughout the development cycle. Long term this position may lead to broader responsibilities as a Materials subject matter expert.
Accountabilities & Responsibilities:
- Utilizes customer requirements to develop processes to manufacture innovative medical devices for vascular projects. Assignments may begin as initial concepts, evolve into 'hands-on' prototyping, and conclude with transfer into high volume manufacturing.
- Integrates and transfers both emerging and existing technologies and materials into technical capabilities for laser-cut products with the focus on nickel-titanium alloys, stainless steels, cobalt-chromium alloys, and refractory and precious metals.
- Implements both established and newly developed solutions to complex technical challenges. Initially, the scope will include primarily acid processing, thermal processing, cleaning, passivation, and waste stream handling.
- Develops and documents test methods to evaluate product performance.
- Works with program managers and other Integer sites to align efforts throughout the cardio and vascular division.
- Develops and reviews test procedures and plans prior to implementation, conducts failure analysis and inspection on products, processes and materials.
- Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.
- Provides planning inputs and executes on project deliverables to meet established metrics.
- Generates, reviews and approves engineering change orders.
- Investigates root cause for product and process failures and establishes corrective actions.
- May supervise and mentor lower level engineers, technicians, and operators.
- Authors technical documents including but not limited to: standard operating procedures, technical memorandums, validations, input/output matrices, and specifications.
- Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
Education & Experience:
- Bachelor's degree in related Engineering or similar technical field. Masters degree preferred.
- Preferred degree fields include Materials or Chemical Engineering, but degrees in Mechanical Engineering, Chemistry, Physics or other fields with the applicable experience will be considered.
- Minimum 5 years of experience or 3+ years with an advanced degree.
Knowledge & Skills:
- Reasonable depth of knowledge and experience in at least some of the focus areas including acid processing, thermal processing, mechanical property testing, and metallic materials used in medical devices. Specifically, experience with heat treating, acid etching, electropolishing, finishing, and/or joining would be advantageous.
- Experience with design controls, FDA/ISO regulations, or other regulatory controls.
- Reasonable proficiency with CAD is advantageous.
- Process development and prototyping capabilities including design of experiments, process qualification, FMEA, tolerance analysis, design for manufacturability (DFM) and other methods.
- Demonstrated problem solving skills. Proficiency with root cause and statistical analysis tools.
- Well organized with strong verbal, written and interpersonal communication skills for effectively interfacing with internal/external customers in a team environment.
- Demonstrated ability to lead team activities and drive projects to completion.
- Ability to plan, schedule, conduct, or coordinate detailed phases of the engineering work as part of a major project or total project of moderate scope and drive to completion