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Team Member

ACIST Medical Systems, Inc.

Team Member

Eden Prairie, MN
Paid
  • Responsibilities

    At ACIST, EVERY EMPLOYEE and EVERY PRODUCT has the POWER TO MAKE A DIFFERENCE! 

    We develop, manufacture, and market new and existing products that empower our customers to better diagnose and treat their patients. Our diagnostic and interventional products simplify the complexities of the cardiac cath lab in order to improve the quality of life for our patients around the globe.

    We care as much about our employees as we do our patients.  Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way.  Each member of the ACIST team has the POWER TO MAKE A DIFFERENCE…. EVERY DAY! 

     

    POSITION SUMMARY:

    Utilize hands-on experience with medical device manufacturing processes, methods and tools to maintain and improve our hardware manufacturing assembly area. Frequently act as a key resource during product development and process improvement initiatives. Utilize design for manufacturing (DFMA) methods and tools to create and optimize manufacturing processes and influence design outcomes that are robust and efficient. Work closely with the production, supply chain, and quality teams to assure manufacturing output is achieved. Exercise Lean and TOC principals to optimize our throughput and improve our quality levels.

    Provide project management support for a large suite of enhancement and obsolescence projects as well as manufacturing process improvement initiatives that enable improved cost, quality and the continued supply of product for worldwide operations. This position is responsible for the selection of approach, methods, means and documentation for controlling, approving and validating manufacturing output. Must manage multiple projects of varied scope.

     

    PRIMARY DUTIES AND RESPONSIBILITIES

     

    +--------------------------+--------------------------+--------------------------+ |   |   | MANUFACTURING TECHNICAL | | | | SUPPORT | | 50 % |   | | | | | - Identifies released | | | | product design and | | | | manufacturing | | | | process issues, | | | | evaluates critical | | | | nature, determines | | | | root cause, develops | | | | design and process | | | | solutions, and | | | | implements solution. | | | | - Supports the | | | | manufacturing | | | | operation on a daily | | | | basis to ensure | | | | production of | | | | product | | | | - Effectively utilizes | | | | broad knowledge of | | | | materials and | | | | manufacturing | | | | processes to create | | | | and maintain | | | | documentation | | | | suitable for | | | | regulatory | | | | submissions | | | | - Works | | | | cross-functionally | | | | to ensure design | | | | addresses internal & | | | | external supplier | | | | needs | | | | | | | |   | +--------------------------+--------------------------+--------------------------+ |   |   | PROJECT MANAGEMENT AND | | | | DOCUMENTATION | | 20 % |   | | | | | - Rigorous | | | | documentation for | | | | all phases of | | | | projects, including | | | | design | | | | specifications, | | | | verification test | | | | plans, project | | | | schedules, and | | | | change orders | | | | associated with | | | | medical devices. | | | | - Routine | | | | communication with | | | | peers and | | | | supervisors | | | | including | | | | documentation of | | | | work, meetings, and | | | | decisions | | | | - Develops & maintains | | | | project plans, | | | | coordinates project | | | | activities, | | | | sets/adheres to | | | | milestones, ability | | | | 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. | | | | | | | |   | +--------------------------+--------------------------+--------------------------+ |   |   | TECHNICAL CONTRIBUTION | | | | AND PROJECT MANAGEMENT | | 20% |   | LEADERSHIP | | | | | | | | - Provide work | | | | direction, coaching, | | | | and guidance to Jr | | | | team | | | | members (in-direct) | | | | - Promote peer | | | | development and | | | | foster team growth | | | | through: | | | | - Demonstrated | | | | excellence in | | | | technical | | | | contribution | | | | - Open dialog with | | | | peers to share | | | | experience and | | | | knowledge | | | | - Continuous | | | | demonstration of | | | | Project | | | | Management best | | | | practice | | | | | | | |   | +--------------------------+--------------------------+--------------------------+ |   |   | QUALITY, COMPLIANCE, AND | | | | REGULATED PRACTICES | | 10% | | | | | | - 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 | | | | - Ability to support | | | | Operations during | | | | audits as SME for | | | | assigned areas | +--------------------------+--------------------------+--------------------------+

    Required Skills

    QUALIFICATIONS (KNOWLEDGE, SKILLS & ABILITIES):

     MINIMUM:

    • BS Mechanical Engineering / Manufacturing Engineering / Systems Engineering / Electrical Engineering / Biomedical Engineering
    • 10+ years’ experience in the Medical Device industry
    • Working knowledge of project management software and tools (e.g. MS Project) and methods
    • Ability to coordinate multiple projects simultaneously
    • Strong interpersonal and communication skills
    • Strong problem-solving skills
    • Knowledge of QSR, ISO/EN and Quality System Standards
    • Technical writing skills
    • MS Office suite

     

     

    PREFERRED:

    • Deep DFM, FMEA, statistical analysis knowledge/understanding
    • Supplier management experience
    • Prior experience working within a Med Device QA dept or capacity
    • Deep Medical Device quality system experience
    • Tubing and tubing bonding methods
    • Experience with packaging
    • Experience implementing design changes with Contract Manufacturers

     

     

     

    Required Experience

  • Qualifications

    QUALIFICATIONS (KNOWLEDGE, SKILLS & ABILITIES):

     MINIMUM:

    • BS Mechanical Engineering / Manufacturing Engineering / Systems Engineering / Electrical Engineering / Biomedical Engineering
    • 10+ years’ experience in the Medical Device industry
    • Working knowledge of project management software and tools (e.g. MS Project) and methods
    • Ability to coordinate multiple projects simultaneously
    • Strong interpersonal and communication skills
    • Strong problem-solving skills
    • Knowledge of QSR, ISO/EN and Quality System Standards
    • Technical writing skills
    • MS Office suite

     

     

    PREFERRED:

    • Deep DFM, FMEA, statistical analysis knowledge/understanding
    • Supplier management experience
    • Prior experience working within a Med Device QA dept or capacity
    • Deep Medical Device quality system experience
    • Tubing and tubing bonding methods
    • Experience with packaging
    • Experience implementing design changes with Contract Manufacturers