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Director, Global Operations Engineering




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

Position Summary:

This is a technical, hands-on director role that leads the ACIST global operations engineering team. This position is responsible for enhancing operations engineering strategic direction, and ensuring work is performed in accordance to Quality Management System (QMS) and Regulatory Requirements. The director owns operations engineering responsibilities for new product development, sustaining and in-house manufacturing and global contract manufacturing of capital systems and consumables. This role works collaboratively to successfully complete prioritized new products, product enhancements and  component obsolescence and improvement projects. This position has accountability to develop and manages operations engineering budget as well as identify and take action on appropriate improvement opportunities.

Primary Responsibilities:

People Leadership (~60%)

  • Ensures operations engineering strategic alignment to the overall business and oversees the development and execution of plans
  • Cultivates operations engineering team, fosters career development (including future leaders), provides clear objectives and feedback to team members, actively on-boards and assimilates new employees and supports team through challenges
  • Performs personnel functions, including identifying resource needs, hiring, on-boarding, performance evaluations, terminations, promotions and salary decisions
  • Continues development, motivates and engages high performing employees and teams through:
    • Continuous one-on-one feedback
    • Team and employee recognition
    • Coaching and mentoring
    • Skills development
    • Performance Management
  • Organically and inorganically grows team’s knowledge and capabilities while enhancing cross-functional collaboration
  • Transfers knowledge and experiences to others, facilitates the opportunity for team members to develop the required process expertise
  • Provides transparent communications and encourages active exchange of ideas and information
  • Nourishes collaborative relationship with other departments (product development, supply chain, manufacturing, quality, customer support, field services, finance, sales and marketing)
  • Facilitates trade-off discussions, helps set and clearly communicates priorities

Projects, Products and Process Improvements (~40%)

  • Utilizes metrics to identify and take appropriate actions to improve product performance and reliability; reduce lead-times, scrap, rework and operating costs; increase capacity; enhance customer experiences; and meet our commitments
  • Confirms work is performed in accordance with Regulatory Requirements and Quality Management System (QMS), including development and maintenance of documentation
  • Ensures team has a thorough understanding of product and process requirements (inputs, outputs and interactions) so capabilities can be quantified, enhancements and creative solutions identified and appropriate changes implemented
  • Provides leadership to operations engineering team to successfully execute our strategies and meet our commitments:
    • Accomplish objectives
    • Successful completion of projects
    • Product development
    • Process & product improvements (including sustaining)
      • Includes prototypes, manufacturing, product end-of-life, service & repair support
      • Includes capital equipment and consumables
      • May occur at ACIST or at one of our contract manufacturers
  • Partners with cross-functional team to actively manage contract manufacturers and suppliers in support of business strategies
  • Uses data, product application (use-cases), internal and external information, knowledge of healthcare and sound engineering judgment to make decisions such as assessing risk, prioritizing projects and deploying resources
  • Utilizes suitable methodologies to prioritize projects, resource requests and allocations
  • Implements ergonomic processes to preserve a safe work environment for our employees
  • Develops and actively manages 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: 

Required

  • BS in Engineering or equivalent
  • 10+ years leadership experience, 7+ years engineering experience, preferably in the medical device industry including software driven electronic devices and associated consumables
  • 5+ years medical device experience
  • Proven ability to mentor and develop a technical team
  • Experience developing, prioritizing and implementing operational strategies, best practices and improvements
  • Cognitive capacity to adapt current knowledge to understand, support and confidently convey critical and complex information regarding our products and processes
  • Familiarity with designing, developing, prototyping, validating and implementing product and process improvements
  • Knowledge of a variety of manufacturing and assembly processes
  • Experience utilizing problem solving and applying continuous improvement methodologies and tools
  • Aptitude to identify required data, collect, consolidate and analyze for assessment, decision making and reporting
  • Passion and commitment to learn and improve to achieve personal and company goals
  • Highly collaborative and desire to build strong relationships with all team members
  • Assertive self-starter with excellent organizational, interpersonal, critical thinking, verbal and written communication skills
  • Passion and commitment to learn and improve to achieve personal and company goals
  • Highly collaborative and desire to build strong relationships with all team members
  • Assertive self-starter with excellent organizational, interpersonal, critical thinking, verbal and written communication skills
  • Ability to travel up to 25% (domestic and international)

Preferred

  • MBA
  • Strong knowledge of a variety of manufacturing and secondary processes (i.e. PCBAs, electrical circuits, motors, sensors, switches, control systems, molding, machining, extruding, forming, welding, 3D printing, conformal coating, anodizing, passivation, electro-polishing, painting, etc.) and assembly operations (design for manufacturability)
  • Thorough knowledge of statistical methods, problem solving and continuous improvement tools (i.e. histograms, pareto charts, run charts, control charts, process capability, probability plots, Process Flow Diagrams, Process Maps, critical inputs and outputs, 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)
  • Comprehensive problem solving and application of continuous improvement methodologies and tools (i.e. PDCA, DMAIC, A3, 8D, CAPA)
  • Experience supporting both capital and 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)

Job Location

Eden Prairie, MN

Tracking Code

715-432

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