Mechanical Design Engineer

*CURRENT EMPLOYEES : Please click here to be redirected to the internal career site. Job Description The Mechanical Design Engineer will be based in Medical Device Design Center in Irving, TX. and will be responsible for design in conjunction with multidisciplinary engineering team, to develop new products, support ongoing manufacturing activities, and new product introduction (NPI) for electromechanical and disposable medical device systems. Provide medical device compliance knowledge, design expertise, technical competency, while contributing to a team designing and developing innovative mechanical and electro-mechanical medical devices or subsystems in a contract design and manufacturing environment. Work on cutting edge medical device products to design and implement innovative and cost-effective product solutions of complex scope in order to support the organization from early prototype development through full-scale production or anywhere in between.We are looking for someone who demonstrates:Intense collaborationPassionate customer focusThoughtful, fast, disciplined executionTenacious commitment to continuous improvementRelentless drive to winHere is a glimpse of what you'll do:Apply knowledge of mechanical design to medical device requirements for biocompatibility, sterilization, safety and efficacy, and Flex medical product development life cycle (FPLC).Work independently and with a team of mechanical engineers to provide complete mechanical direction, technical expertise, coordination, and control of the activities necessary to design, document, fabricate, debug, and test both disposable and durable medical device products. To include but not limited to: product design, feasibility prototyping, risk management, technical design feasibility, tolerance stack analysis (TSA), stress analysis (FEA), fluid flow analysis, interface with tooling, mold flow analysis, DF(x) analysis (design for ... [assembly, reliability, cost, etc.]), design input development, design output verification plan, test method development support, support development of inspection requirements, metrology planning, working BOM development, suppliers/vendors, product data management (PDM/Agile), design reviews, planning, scheduling, technical writing, documented engineering testing, oversee engineering builds.Execute, collaborate, and bridge technical challenges with other cross functional engineering and support including: equipment development, packaging, tooling, systems, process, electrical, software, quality engineering, industrial design, human factors, program management, sourcing, and procurement.Translate customer requirements and convey in to testable mechanical requirement specifications (MRS). Work with cross functional team to merge MRS into full system product requirement specifications (PRS). As necessary work directly with customer to design, develop, and implement full mechanical design effort.Support project engineer or design team in generation of accurate proposals for the mechanical engineering engagement portion in the design, development, and implementation of medical device product development.Including NRE (non-recurring engineering) cost, capital cost, expense cost, scope of work (SOW), and schedule.Perform risk analysis based on ISO 14971 Medical devices - Application of risk management to medical devices. Support presentation and execution of technical reviews and/or formal design reviews for mechanical systems/sub-systems.Follow Flex design control procedures (FPLC) and execute efficiently.Execute with an emphasize on results oriented, solution based, engineering driven design solutions.Perform project task as needed to successfully execute project within budget, timeline, and quality requirements.Apply complex design practices and procedures to assigned product portfolio in areas such as sheet metal design/fabrication, injection mold part design, motion and drive systems, soft tooling processes (sheet metal stamping/fabrication, tig/mig/spot welding) and machine design.Work Environment:Customer facing role to support start-ups to large companies, market specific projects, and internal design projects from sketch to scale.Provide a key role in understanding the individual product requirements and proposing design solutions and helping customers architect, develop, implement and bring to market key and ground breaking new mechanical design solutions.Execute best practices within the mechanical team and develop a deep understanding of the worldwide ME design capabilities at Flex.Bring a high level of enthusiasm, positive outlook, and inquisitiveness to participate on a cross-functional team to resolve technical challenges.Further develop medical device requirements knowledge, Flex design processes, best practices, and proper documentation techniques.Seek peer review on design and development direction. Work with large team of highly experienced and diversified engineers to develop state of the art medical device products and processes.Confer with support teams to clarify or resolve problems and develop corrective action, method improvement to resolve problems.Work with quality test engineering to analyze inspection and test data and reports to determine if design meets functional and performance specifications.Provide complex technical support to customer base to enhance manufacturability and assembly while minimizing costs.Here is some of what you'll need (required):Bachelor's Degree in mechanical engineering or related fields.15 + years of experience in the field or related area.Knowledge of mechanical design to medical device requirements for biocompatibility, sterilization, safety and efficacy.Experience within a highly regulated environment (e.g. Medical, Aerospace, etc.).Proficient in SolidWorks, PDM and CAD file management software.Experience in DFX, FEA, and DFMEA.A Great communicator - verbally and writtenmechanical engineerPresentation skills strong knowledge in PowerPointKnowledge of IEC 60601.Medical industry experience and familiarized with FDA and ISO 13485Well organized & disciplined, good attention to detail, sets priorities and manages time effectivelyAbility to interface and communicate with different levels of the organization#LI-LD1LD50Here are a few examples of what you'll get for the great work you provide:Full range of medical benefits, dental, visionLife InsuranceMatching 401KPTOTuition ReimbursementEmployee discounts at local retailers Job Category Design & TechnologyRelocation Is Sponsorship Available? NoFlex does not accept unsolicited resumes from headhunters, recruitment agencies or fee based recruitment services. Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. Flex does not discriminate in employment opportunities or practices based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status or any other status protected by law. Flex provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process. Please advise us of any accommodations you request to express interest in a position by e-mailing: accessibility@flex.com. Please state your request for assistance in your message. Only reasonable accommodation requests related to applying for a specific position within Flex will be reviewed at the e-mail address. Flex will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with Flex.The information we collect:We may collect personal information that you choose to submit to us through the Website or otherwise provide to us. This may include your contact details; information provided in online questionnaires, feedback forms, or applications for employment; and information you provide such as CV/Resume. Your details will be provided to the entity you are applying for a job with. We will use your information for legitimate business purposes such as responding to comments or queries or answering questions; progressing applications for employment; allowing you to choose to share web content with others or; where you represent one of our customers or suppliers, administering the business relationship with that customer or supplier. We will process your data in accordance with our Recruitment Privacy Notice.If you have any queries about the processing of your data, please contact:Global Data Privacy Officer:Email Address: dataprotection@flex.com

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