Senior Manufacturing Engineer
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:
Hands-on and knowledgeable in the area of Medical Device Manufacturing and Design. Acts as a key resource during product development and process improvement initiatives. Utilize Design For Manufacturing (DFMA) and Good Manufacturing Practice (GMP) methods and tools to create processes and designs that are robust and able to be manufactured economically. Work closely with production, supply chain, quality and the development groups to assure manufacturing output is achieved. Works under the guidance of Manufacturing Engineering management and other Project Managers regarding manufacturing capabilities, production schedules, and other considerations to facilitate production process and design releases in accordance with business goals.

Primary Duties and Responsibilities:
Projects – Process and Product Development

Plans, directs, and coordinates manufacturing development activities around design and processes for medical device assembly and service

Coordinate the installation of new manufacturing and test equipment which includes IQ, OQ and PQ execution

Provides management of lean manufacturing projects chartered to improving current manufacturing methods and/or design

Participates or leads cross-functional team meetings concerning product design and selection of tooling, vendors, materials, etc. to ensure efficient production methods are selected and the product meets requirements

Key representative on a project, product, and/or process development activity who brings forth the utilization of GMP and Design For Manufacturing (DFMA) methodologies to assure and improve efficiencies and product designs

Production Support

Supports the manufacturing operation on a daily basis to ensure production of product

Troubleshoots design or process issues, implements improvements, and supports all other daily activities such as NCMR (Non-Conforming Material Review), re-work, and implementation of change orders

Analyzes processes and creates methods for process and quality monitoring including development of and reporting of metrics

Technical Documentation and Training

Writes technical documentation such as manufacturing assembly and test process, test protocols and validation protocols for use in a regulated environment

Provides reference to technical resources (Technicians, Engineers and Assemblers), to ensure drawings, work instructions, methods are fully defined and validated and able to be effectively conveyed to the production staff

Releases drafted assembly procedures and appropriate documentation utilizing the Change Order Process

ACIST Medical Systems

Required Skills

Minimum:
BS in an engineering discipline

6 - 8 yrs. experience as a Manufacturing Engineer in a regulated industry

Ability to assimilate technical concepts quickly and present technical information clearly and concisely for technical and non-technical audiences

Moderate to high level of computer proficiency including MS Office Suite, SolidWorks, ERP Systems

Effective oral and written communication skills

Demonstrated organizational and administrative skills

Ability to prioritize and handle multiple tasks

Ability to interpret, follow and promote the quality policy of the organization as an operating guideline

Ability to work both independently and as part of a team

Preferred:
BS in Manufacturing, Mechanical or Industrial Engineering

Demonstrated expertise in a variety of process technologies and manufacturing environments

Demonstrated ability to lead and manage initiatives and small scale projects

Electromechanical device assembly experience

Facility and production cell layout experience

Required Experience

About this company
ACIST® Medical Systems is a global medical device company that develops advanced contrast injection technologies that help simplify the...