Mechanical Engineer II

ACIST Medical
7905 Fuller Road

Eden Prairie, MN

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Mechanical Engineer II

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 components used in electro-mechanical, software-controlled devices and related disposable kits primarily used in medical imaging segments
Cooperates with and understands the design challenges being addressed by other project team members and product managers,  and goes forth in designing medical/patient care solutions and products that are suited for ease of manufacturing, assembly, service, use, etc using DFx principles while meeting the needs of the customer
Effectively utilizes 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
Project Management and Documentation

Rigorous documentation for all phases of product development, including design specifications, verification test plans, project schedules, 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
Maintain project plans, set/adhere to milestones, deliverables and budgets, and may manage a limited number of concurrent projects primarily of a mechanical scope and consisting of 1-2 designers or technicians
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 & Abilities):

Where permitted by applicable law, must have received or be willing to receive the COVID-19 vaccine by date of hire to be considered for U.S.-based job, if not currently employed by Bracco Medical Technologies/ACIST Medical Systems.
BS Mechanical Engineering or similar
Working knowledge of finite element analysis, tolerance analysis, and geometric tolerance.
3+ years of experience as a mechanical engineer
Strong interpersonal and communication skills.
Technical writing skills.
Design of injection molded components
CAD experience and knowledge of CAD system structure.
Ability to remain productive with minimal supervision
Ability to coordinate multiple projects simultaneously

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

Job Location
7905 Fuller Road, Eden Prairie, Minnesota

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