Sr. Manufacturing Engineer
OSI Systems
Manufacturing EngineerAt Spacelabs Healthcare, you make a difference.Every member of our worldwide team plays an integral role in improving treatment and helping providers deliver exceptional care to their patients. From newborns to centenarians, more than 60 million people benefit each year from the advancements we make in patient monitoring and management, care coordination, and clinical decision support.Driven by the belief that anyone who seeks care could be a member of our own family, our team is dedicated to solving the greatest challenges the healthcare system currently faces, including the need to enhance the patient experience, improve population health, reduce costs, support care team well-being and advance health equity. As part of our mission, we take pride in creating services and technologies that are personalized and tailored to support the needs of healthcare providers anywhere in the world.Because while we may not be at a patient's bedside, their health is still in our hands.Spacelabs Healthcare is looking for a proficient manufacturing engineer with experience in electronics and PCBA component replacement. Responsibilities include process and design improvements, quality improvements, cost reduction, alternative component selection, qualification, and approval, as well as collaboration with R&D to ensure new products are manufacturable, testable, serviceable, and reliable. This position is part of a multi-disciplinary team; a high level of collaboration with other members is essential to the overall success of the team.This position is located in Snoqualmie, WA and requires 100% on-site collaboration.ResponsibilitiesDevelop, document, improve, and own manufacturing processes. Create process plans and equipment designs and document process validations. Perform product and process verifications and validations.Establish, simulate, design, test, and implement improvements to our existing products with a focus on cost and quality.Act as a subject matter expert on bills of materials, drawings, specifications, labels, licenses, and associated changes.Complete root cause and failure analysis for field failure problems related to design or manufacturing of the product.Leads cross-functional initiatives that impact product quality, manufacturability, cost, and supply continuity.Influences product design decisions and manufacturing strategy through early engagement with R&D.Review, disposition, and investigate nonconformity (NMRs) and work with QA & supply chain to determine how to address it including potential rework instructions to bring to conformity.Establishes and maintains manufacturing engineering standards, best practices, and validation methodologies.Maintain the integrity and quality of our products, ensuring conformance to specifications and compliance with all regulatory requirements, including FDA, MDD, UL, CSA, etc.Resolve obsolescence and supply chain shortages through component selection or design change.Provides mentoring and technical guidance to Manufacturing Engineers and TechniciansUphold the company's core values of Integrity, Innovation, Accountability, and Teamwork.Demonstrate behavior consistent with the company's Code of Ethics and Conduct.It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.Duties may be modified or assigned at any time to meet the needs of the businessQualificationsBachelor's Degree in Electronics Engineering or Manufacturing Engineering or equivalent experience.8+ years of relevant manufacturing engineering experience.Experience in electronics design preferred.Related experience in medical device field.Knowledge of medical product release process into manufacturing required (IQ, OQ, PQ, TMV, verification and validation activities is desired).Exhibits ability to independently analyze and solve complex issues, utilizing root cause analysis tools and implementing effective solutions.Exhibits ability to proactively collaborate and communicate effectively with cross-functional partners to solve problems and drive positive change for the organization.Experience working positively and productively in a team environment; highly collaborative. Ability to manage multiple, complex priorities within demanding timeframes.Problem-solving skills and organized work methods with attention to detail.Ability to work independently and proactively with minimal supervision.
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