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ACIST Medical Systems Mechanical Engineer I in Eden Prairie, Minnesota

Mechanical Engineer I Why Join ACIST? We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the ACIST team has the power to make a difference......every day! Position Description Uses creativity and accepted engineering practices in the design and analysis of machine and component designs primarily suited for use in medical devices. Mechanical development work is iterative and enduring with significant expectations placed on documentation. The position is responsible for the selection of approach, materials, methods, and means for approving and validating output. Primary Duties and Responsibilities: Technical Development and Analysis Designs, develops, prototypes, measures, and tests mechanical hardware and disposable kits used in electro-mechanical, software controlled devices primarily used in medical imaging segments Supports other project team members and product managers with design challenges being addressed. Effectively utilizes broad knowledge of materials and manufacturing processes to create and maintain documentation suitable for manufacturing transfer and regulatory submissions Designs FBD of mechanical systems and uses them to guide analysis of models and function of mechanisms. Provides hands-on development and support from product conception to end of life Maintain skills and awareness of technical improvements and competition advancements Maintain basic understanding a manufacturing processes and methods Maintain and utilize 3d printing software and hardware for prototyping use Submit purchase orders for prototype pieces, hardware, shop/lab supplies, etc Project Management and Documentation Rigorous documentation for all phases of product development, including design specifications, verification test plans, CAD models, drawings, and change orders associated with medical devices and consumable products. Routine communication with peers and supervisors including documentation of work, meetings, and decisions Set/adhere to milestones, deliverables and budgets, and manage a limited number of concurrent projects primarily of a mechanical scope Ensure that team meetings, project reviews, and action lists are kept current and communicated to all stakeholders in a timely fashion Direct outside contract personnel as needed for completion of specific tasks. Quality, Compliance, and Regulated Practices Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation Designs products to meet requirements regulated by FDA, UL, CE, and other governing bodies as defined by product management Participates in selection of vendors and fabrication sources to assure quality and compliance to released specifications Committed to fostering and driving an environment and work output based on continuous improvement Qualifications (Knowledge, Skills and Abilities): Minimum: BS Mechanical Engineering Working knowledge of finite element analysis, tolerance analysis, and geometric tolerance. Completed internship/co-op Strong interpersonal and communication skills. Technical writing skills. Design of injection molded components Tolerance analysis proficiency CAD experience and knowledge of CAD vaulting system. Ability to remain productive with minimal supervision Ability to coordinate multiple projects simultaneously Preferred: SolidWorks experience preferred Drawing management system knowledge Working knowledge of medical terminology. Experience in a regulated medical device industry Knowledge of QSR, ISO/EN and Quality System Standards. Project management experience Basic electromechanical and SW skills (Building/Programming Arduino based mechanisms) Job Location 7905 Fuller Road, Eden Prairie, MN Tracking Code 757-432 ACIST Medical is an equal opportunity employer and all qualified applicants will

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