A BDN client is looking for a Sustaining Engineer who will serve as a team member and/or leader for quality activities, including process improvements, validations, and complaint investigations. The primary work station is located in an office with most of the time spent in a cleanroom environment.
Has the primary responsibility for implementing the position’s key responsibilities as they apply to existing products. They will collaborate with manufacturing engineering to maintain and improve existing products and to ensure regulatory and product performance requirements are met.
Participates in and leads the investigation of nonconformances related to complaints and CAPAs. They will implement robust solutions for process/device nonconformances; contributes to Material Review Board, and supports improvement initiatives.
Develop and/or review Process Qualifications, Test Method Validations, Gage R&R's, Process Capability studies, Design of Experiment (DOE), and production control plan.
Provide direction in implementing First Article Inspection, In-Process Inspection, Sampling Plan, product/components testing, inspection and acceptance criteria.
Use data-driven approaches to evaluate product performance and conformance.