Manufacturing Engineer III

Overview At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients. Why work at Spacelabs? Because lives depend on you! The Manufacturing Engineer III is responsible for engineering support of the assigned product portfolio, with focus on supplies and accessories products. New Product Introduction responsibilies include collaboration with the R&D team to ensure new products are manufacturable, testable, serviceable and reliable. Sustaining engineering responsibilities include quality improvements, customer responsiveness improvements, cost reduction, alternative component selection and approval. 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. Responsibilities Develop and review functional test procedures, primarily for cables, patient lead wires, and blood pressure cuffs. Develop, document, and improve manufacturing processes. Create process plans and equipment designs, and document process validations. Perform product and process verifications and validations. Make product design improvements, including cost reductions and reliability improvements, as part of a team or as team lead for product improvement projects. Create/Update verification and validation plans and reports when necessary as part of these efforts. Maintain bills of materials, drawings, specifications, labels, licenses, and their associated changes. Review Risk Files & PRD when analyzing potential product changes. Work with the materials support team to certify vendors for direct to stock/line programs. Resolve vendor quality issues, disposition/reduction of discrepant materials. Provide knowledge and assistance to the new product development (R&D) process, production, and materials teams. Qualify replacement components when existing components are changed or obsoleted. Generate rework/retest instructions and engineering orders. Complete root cause failure analysis and corrective actions for field failures, production problems and failed components; and create engineering changes including validation testing. This includes approval of documents and training affected personnel. Perform or provide direction for third parties for functional testing and generate reports. Work with OEM manufacturers to ensure proper verification and release of products. Work with vendors to understand manufacturing processes and determine how to verify and validate vendor requested changes. Review nonconformity (NMRs) and work with QA & supply chain to determine how to address it including potential rework instructions to bring to conformity. Support customer teams in production. Maintain the integrity and quality of our products, ensuring conformance to specifications and compliance with all regulatory requirements, including FDA, MDD, UL, CSA, etc. Ensure that safe operating procedures are developed, communicated, and followed by all personnel. Select and utilize equipment; introduce applicable production tooling and test systems. Uphold 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 Spacelabs Healthcare 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 business. Qualifications BS degree in Electrical Engineering, Mechanical Engineering, Manufacturing Engineering or other related technical field, or 2-year technical Associates degree plus 2 additional years of experience). 5+ years of directly related work experience preferred (overall experience determines level). Related experience in manufacturing environment. Experience with cables and lead wires highly desired. May require specific experience in one or more of the engineering disciplines (mechanical, electrical, computer, system test, etc.). Experience in medical device or capital equipment preferred. Experience working in an FDA-controlled environment is highly desirable. Experience working positively and productively in a team environment; highly collaborative. Ability to manage multiple, complex priorities within demanding timeframes. Project management and problem-solving skills. Organized work methods with attention to detail. Demonstrated competency in computer skills: MS Office applications, query and networking tools, and enterprise database systems. Ability to work independently and proactively with minimal supervision. Please review our benefits here: Life at OSI The specific programs and options available to any given employee may vary depending on eligibility factors such as geographic location and date of hire. Please note that the salary information shown above is a general guideline only. Salaries are based upon candidate experience and qualifications, as well as market and business considerations. Company COVID-19 Vaccine Policy To comply with applicable government requirements, all U.S. employees must be fully vaccinated against COVID-19 unless they are entitled to and approved for a legal accommodation, in accordance with the Company’s COVID-19 Vaccination Policy. NOTICE TO THIRD PARTY AGENCIES OSI Systems, Inc. and its subsidiaries (collectively “OSI”) does not accept unsolicited resumes from recruiters or employment agencies. If any person or entity, including a recruiter or agency, submits any information, including any resume or information regarding any potential candidate, without a signed agreement in place with OSI, OSI explicitly reserves the right to use such information, and pursue and/or hire such candidates, without any financial obligation to the person, recruiter or agency. Any unsolicited information or resumes, including those submitted directly to hiring managers, are considered and deemed to be the property of OSI. Equal Opportunity Employer - Disability and Veterans EEO is the Law Poster Link: https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.