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Senior Operations Engineer - Consumable Products




Why Join ACIST?

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 Description

 

In this role, you will work cross functionally with quality, regulatory, R&D, marketing, and supply chain partners to translate customer and business needs into safe, effective, and quality commercial products. Operations responsibility for product and process designs, documentation, equipment design, and specifications and adherence to Acist’s Quality Management System (QMS) and regulatory requirements. Manage multiple vendors and projects of varied scope, provide work direction and mentor junior engineers, and lead projects to optimize and improve quality, costs, capacity, and the continued supply of product for worldwide operations.

 

Primary Duties and Responsibilities:

Operations Engineering

  • Responsible for commercial product quality, cost, and delivery at contract manufacturer
  • New product launch and master validation plans
  • Design and process change implementation
  • Process monitoring and improvements
  • Root cause analysis and problem solving
  • Performs work in accordance with Regulatory Requirements (i.e. FDA, MDR, UL, CE and other governing bodies) and Quality Management System (QMS), including development and maintenance of documentation
  • Enhances and utilizes metrics to identify opportunities, prioritize, lead projects and implement necessary changes focused on; supporting daily production; improving product performance and reliability; product enhancements; component obsolescence, increasing capacity and process capability; reducing lead-times, scrap, rework and operating costs; enhancing customer experiences; and meeting our commitments
  • Uses data, product application (use-cases), internal and external information, knowledge of healthcare and sound engineering judgment to make decisions
  • Utilizes appropriate problem solving and continuous improvement tools
  • Develops, maintains & communicates project plans, coordinates project activities, sets / adheres to milestones and action list
  • Partners with cross-functional team to actively manage contract manufacturers and suppliers in support of business strategies
  • Provides process & product line support from prototype to manufacturing (may occur at ACIST or at one of our global contract manufacturers), product end-of-life support and customer usage
  • Supports daily manufacturing activities
  • Ensures new product designs are resilient and manufacturing processes are capable
  • Frequently acts as a key resource / subject matter expert (SME)
  • Daily ownership of product lines and processes
  • Works closely with assemblers and technicians (at ACIST) or with global contract manufacturers to provide guidance and share knowledge
  • Works as an integral member of a product core team, helps to define requirements, creates processes and test systems, identifies suppliers and ensures products meet customer and market expectations
  • Implements ergonomic processes to preserve a safe work environment for our employees

People Leadership

  • Works collaboratively with other departments (product development, supply chain, manufacturing, quality, customer support, field services, finance, sales and marketing)
  • Provides transparent communications and encourages active exchange of ideas and information
  • Provides work direction to less-senior operations engineers and technicians
  • Mentors, coaches and develops others
  • Collaborates with others who have supplemental knowledge and skills required to complete projects
  • Provides recognition to others
  • Utilizes motivational techniques / tools to drive high levels of employee engagement and performance
  • Transfers knowledge and experiences to others
  • May perform some personnel functions, including identifying resource needs, hiring, on-boarding, performance evaluations, terminations, promotions and salary decisions
  • Contributes to creation and managing operations engineering budget, plans for future resources (human, equipment, etc.), addition of capabilities and future growth projections to support a growing business

Qualifications (Knowledge, Skills & Abilities):

Minimum:

  • Bachelor's in Engineering or equivalent technical degree
  • 5 – 8 years relevant experience
  • 3+ years medical device experience
  • Demonstrated continuous improvement experience
  • Understand system requirements (i.e. GMP, QSR, GLP, CE, CSA, ISO, etc.)
  • Passion and commitment to learn and improve to achieve personal and company goals
  • Work collaboratively with all ACIST team members, including; product development, supply chain, manufacturing, quality, customer support, field services, finance, sales and marketing
  • Experience in project leadership (including writing and executing project plans) with flexible approach and ability to influence others
  • Assertive self-starter with excellent organizational, interpersonal, critical thinking, verbal and written communication skills
  • Use creativity and accepted engineering practices to design, develop, prototype, verify, validate and implement product and process improvements
  • Familiarity with catheter manufacturing and secondary processes (i.e. sterilization, extrusion, bonding, molding, over molding, tipping, flaring, drilling, joining, motors, sensors, switches, control systems, vision systems, machining, welding, soldering, 3D printing, conformal coating, anodizing, passivation, electro-polishing, painting, etc.), test fixtures and assembly operations (design for manufacturability)
  • Ability to identify required data, collect, consolidate and analyze for assessment, decision making and reporting utilizing problem solving and continuous improvement methodologies (i.e. PDCA, DMAIC, A3, 8D)
  • Knowledge of how to properly analyze data sets using statistical software (i.e. Minitab, JMP, LabVIEW, etc.)
  • Understand statistical methods, problem solving and continuous improvement tools (i.e. regression analysis, ANOVA, reliability, equivalence tests, histograms, pareto charts, trend charts, control charts, process capability, Process Flow Diagrams, Process Maps, Value Stream Maps, RCA {5-why, fish bone diagram, cause mapping}, fault tree analysis, cause and effect matrix, prioritization matrix, FMEA, DOE, MSA, MTTR / MTBF, Poka-Yoke, control plans)
  • Ability to travel up to 20% (domestic and international)

Preferred:

  • Proven ability to mentor and develop technical teams
  • Agile / SAP (or similar documentation control / MRP systems)
  • Experience supporting capital and / or consumable medical device products
  • Experience working with medical device contract manufacturers
  • Experience working with different global cultures
  • Technical project management skills / Project Management Professional (PMP)
  • Knowledge of how to use test instruments (i.e. CMM, vision systems, leak tester, tensile tester, multi-meter, )
  • Ability to model in SolidWorks or Altium (or similar)

Job Location

7905 Fuller Road, Eden Prairie, MN

Tracking Code

745-432

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