Sr. Mechanical Engineer (R&D)
Acist Medical Systems, Inc. - Eden Prairie, MN

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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 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

Required Skills

Qualifications (Knowledge, Skills & Abilities) :
Minimum:
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

Preferred:
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

Required Experience

Acist Medical Systems, Inc. - 20 months ago - save job - copy to clipboard - block
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