ACIST Medical Systems is the market leader in providing innovative diagnostic and therapeutic products and services that enable interventionalists and their clinical teams in providing superior patient care. Our focus is “the pursuit of the perfect image” through continuous research and development of new products and technologies – supporting today’s needs and anticipate those of tomorrow. We are an international company, with products in over 45 countries, providing high quality systems and award-winning customer support across the globe.
We believe employees are our greatest asset. ACIST fosters an environment that attracts and retains employees who are proactive, responsive and innovative through commitment to teamwork, communication, feedback and change.
Provide project level leadership and interpretation of specifications to develop fluid path consumable kits and components to be used in imaging injection systems. Significant creativity and experience is essential, using engineering practices in the design and analysis of components. Work is highly directed towards to molding and assembly into kits and configurations intended for single-use and high volume. The position is responsible for the selection of approach, materials, methods, and means for fabricating prototypes used to prove design and validating output with the intent of design transfer and scale-up to facilitate economic production in a high-volume, clean-room environment.
Primary Duties and Responsibilities:
Technical Development and Analysis
Designs, develops, prototypes, measures, and tests consumable devices that interact with mechanical hardware used in electro-mechanical, software controlled devices 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, and test (DFMAT) while meeting the needs of the customer
Utilizes working knowledge of materials, primarily thermoplastics, and manufacturing processes to create and maintain documentation suitable for manufacturing transfer and regulatory submission
Uses math models to evaluate expected product performance for fluid delivery, pressure management, and robustness of plastic patient kits
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
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) :
BS Mechanical / Manufacturing Engineering
Working knowledge of finite element analysis, tolerance analysis, and geometric tolerance.
5 years experience as a mechanical engineer developing consumable products (catheters, valves, closure devices, or similar)
Strong interpersonal and communication skills
Technical writing skills
Design of injection molded components
Packaging and material selection for sterilization and contact with bodily fluids
Proficient in Solid Works and 2DCad experience
Ability to work both autonomously and as part of a team
Ability to coordinate multiple projects simultaneously
Solid Works or Pro/E 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
Familiar with use of 3D printing and design
Acist Medical Systems, Inc. - 17 months ago