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.

Position Summary:

Provide mechanical design support for a large suite of product enhancements and obsolescence projects that support improved cost, quality and the continued supply of product for worldwide operations. Uses creativity and accepted engineering practices to design and develop creative engineering solutions for complex medical devices. The 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.

Primary Duties and Responsibilities:

Technical Development and Analysis

• Identifies 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 mechanical hardware and consumables used in electro-mechanical, software controlled devices
• Works cross-functionally to ensure design addresses internal & external supplier needs
• Effectively utilizes broad knowledge of materials and manufacturing processes to create and maintain documentation suitable for regulatory submissions
• Provides hands-on support for products from commercial release to end of life
• Maintain skills and awareness of technical improvements and competition advancements

Project Management and Documentation

• Rigorous documentation for all phases of projects, 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
• Develops & maintain project plans, coordinates project activities, set/adhere to milestones, manage concurrent projects
• Ensure that 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
• Ensures product meet requirements regulated by FDA, UL, CE and other governing bodies
• Participates in selection of vendors and fabrication sources to assure quality and compliance to released specifications

Minimum:

• BS Mechanical Engineering / Manufacturing Engineering
• Working knowledge of geometric dimensioning & tolerancing, tolerance analysis, finite element analysis
• 5+ years experience as a mechanical engineer in a regulated industry
• Design of injection molded components
• Strong interpersonal and communication skills
• Strong problem solving skills
• CAD experience
• Technical writing skills
• MS Office suite

Preferred:

• 5+ years medical device experience
• Injection molding tooling and processing
• Tubing and tubing bonding methods
• Catheter design and assembly
• Ability to coordinate multiple projects simultaneously
• Knowledge of QSR, ISO/EN and Quality System Standards
• SolidWorks experience
• Project management experience
• Experience with packaging and sterilization
• Experience implementing design changes with Contract Manufacturers