Subject Matter Expert Electronic / Project Manager

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Subject Matter Expert Electronic Subject Matter Expert Electronic Duration: 6 monthsLocation: Canton of Vaud, Switzerland Position Summary: Provide design and project management support in electronic for a large suite of complex medical devices enhancements and obsolescence projects that enable improved cost, quality and the continued supply of product for worldwide operations. This position is responsible for the selection of approach, materials, methods, means and documentation for approving and validating output. Must manage multiple projects of varied scope and adapt process steps including associated documentation part of the DMR and DHF operations.Activities, Duties, Task and Responsibilities Technical Development and AnalysisIdentifies released product design and manufacturing process issues, evaluates critical nature, determines root cause, develops design and process solutions, and implements solution.Designs, develops, prototypes, measures, and tests electronics and hardwareWorks cross-functionally to ensure design addresses internal & external needsEffectively utilizes broad knowledge of materials and manufacturing processes to create and maintain documentation suitable for regulatory submissionsProvides hands-on support for products from commercial release to end of life.CMO, OEM management & coordinationPlan, monitor, technical control and documentation of activities of CMO, Supply Chain, Procurement, and QAKey communication / coordinator between suppliers and companyContributes to the Business Review Meeting: operation engineering and sustaining part.Quality, Compliance, and Regulated Regulatory PracticesPerform work in adherence to the Quality Management System (QMS), including development and maintenance of documentationEnsures product meet requirements regulated by FDA, UL, CE and other governing bodiesParticipates in selection of vendors and fabrication sources to assure quality and compliance to released specifications.Project Management and DocumentationRigorous documentation for all phases of projects (supervise or contribute), including design specifications, verification test plans, project schedules, drawings, and change orders associated with medical devices and consumable products.Routine communication with peers and supervisors including documentation of work, meetings, and decisions Develops & maintains budget, project plans, coordinates project activities, sets/adheres to milestones, ability manage concurrent projectsEnsure that meetings, project reviews and action lists are kept current and communicated to all stakeholders in a timely fashionDirect outside contract personnel as needed for completion of specific tasks.Technical Contribution and Project Management leadershipProvide work direction, coaching, and guidance to Jr team membersPromote peer development and foster team growth through:Demonstrated excellence in technical contributionOpen dialog with peers to share experience and knowledgeStrategy production tools align to the capacity Continuous demonstration of ProjectManagement best practice.Qualifications (Knowledge, Skills & Abilities): Minimum:Master in Electromechanical / Electronical Engineering or Equivalent Education and/or ExperienceProven Experience working with Electronical CAO (Altium or equivalent)10 years' experience in the Medical Device industry10 years' experience in an engineering role, preferably as a manufacturing engineerComfortable with Quality System and Medical Standards, ISO, MDR, IQOQ, DFM, FMEA, ECFStrong interpersonal and communication skills in multicultural environmentFluent in EnglishPreferred:Deep DFM, FMEA, statistical analysis knowledge/understandingStatistical Data Analysis (Minitab)Sthree Switzerland is acting as an Employment Business in relation to this vacancy.