Celestica Operations Engineering Specialist in Monterrey, Mexico
Req ID: 88493
State/Province: Nuevo Leon
Incumbents apply in-depth knowledge in a specific area of specialization. Work is performed within established professional standards and practices. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors and a considerable degree of judgement. Erroneous decisions or failure to achieve results may have a negative impact on the division’s/department’s operations, schedules, and/or performance goals. Works under minimum Supervision. Seeks approval from others on matters outside of job/role scope. Receives instruction on specific assignment objectives and possible solutions. Unusual problems are solved jointly with manager. Work is reviewed for application of sound technical judgment. May lead a work group or project team consisting of technical and support staff. Builds internal and external relationships, with emphasis on those that facilitate the achievement of job/role accountabilities, such as relationships with key suppliers, customers and internal service.
Perform tasks such as, but not limited to, the following:
Provides technical expertise on assigned materials for production or customer-identified material problems. Performs assessments/risk analysis and quality audits on potential suppliers. Generates product specifications and provides to supplier. Performs material qualification on prototype / sample material. Serves as the program/project interface to coordinate new product launches / introductions. Translates customer requirements into factory activities, provides factory activity time estimates for pricing model, documents associated factory support activities, and develops preliminary program timeline for customer quote. Defines process problems that lead to throughput or quality issues, evaluates cause of problem, implements solutions to stabilize processes, evaluates results. Participates in the selection of new manufacturing equipment. Evaluates software and hardware upgrades and new equipment. Sets equipment specifications and develops and runs qualification tests. Gathers, understands and converts customer data into usable manufacturing information. Verifies that specifications conform to customer, industry and company standards. Gathers, analyzes, sorts and distributes data to understand and solve quality issues. Creates and evaluates metrics to drive the quality improvement process. Develops test processes, test fixtures and specialized tools to automate test development. Develops assembly/test processes, associated fixtures, and specialized tools. Automates where ever possible. Develops and implements assembly/test strategy for new products including DFx analysis and feedback.
Write and execute process validation protocols (IQ/OQ/PQ) for medical device equipment.
Responsible of writing and maintain technical information for process, Work Instructions, DHRs, BOMs, defining and modifying production line workflows
It will interact with external contacts, if appropriate, and be monitored
Provide basic technical support on the materials assigned to the production or material identified by the customer
Provide feedback to other engineering groups (Such as Industrial and Quality) and possibly the customer to ensure trouble-free production of products
Solve technical problems of the process, component or material
May participate as internal, external, security and / or any other function required by the company
Support the processing of FMEA and conduct FMEA Risk assessment process and review with cross-functional departments
Support the task of integrating new manufacturing fixtures and equipment in production with emphasis on mistake-proofing
All activities must be performed in compliance with the Quality System, ISO-13485, FDA 21 CFR regulations and GMP (Good Manufacturing Practices) for medical devices
Fluent English spoken and written.
Knowledge of basic engineering.
Knowledge of the industry and quality standards, CPS methodology and good manufacturing practices.
Excellent customer contact, negotiation and problem solving.
In-depth knowledge of the product transaction, contracts and contract negotiations.
Good presentation and administration of database and computer knowledge.
Strong knowledge and understanding of statistical process control methods and techniques.
Understand and interprets FDA 21 CFR regulations and GMP (Good Manufacturing Practices) for medical devices
At least 3 years of experience in manufacturing processes, with work stations and with manufacturing environments, preferably in the medical industry.
Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law).
At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.
Celestica (NYSE, TSX: CLS) enables the world’s best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development – from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud.
Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers.
Celestica would like to thank all applicants, however, only qualified applicants will be contacted.
Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.
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