This is a technical, hands-on Operations Engineering position that is responsible for the design, development, manufacturing, quality, cost, and word wide delivery of electromechanical medical systems. This role functions as an integral member of product development teams, utilizes data to identify opportunities, leads projects and implements changes focused on improving product performance and reliability, product enhancements, component obsolescence, increasing capacity, process capability and meeting our commitments. This individual will nourish collaborative relationships, mentor and transfer knowledge and experience to others, contribute to the creation and management of operations engineering budget, and may perform some personnel functions. All work will be done in accordance with Regulatory Requirements and Quality Management System.

Product Development & Operations Support

• 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

• Supports compliance to Regulatory Requirements
• IEC 60601 Electrical Safety Testing
• 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

• 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

• Works as an integral member of new product development teams, 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

Works closely with assemblers and technicians (at ACIST) or with global contract manufacturers to provide guidance and share knowledge

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

This position has supervisory authority for up to one report.

Qualifications (Knowledge, Skills & Abilities):

• B.S. in Engineering or equivalent degree (i.e. Physics)
• 5 – 7 years relevant experience in a Manufacturing environment
• 4+ 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 some manufacturing and secondary processes (i.e. sterilization, PCBAs, electrical circuits, motors, sensors, switches, control systems, molding, machining, extruding, forming, welding, 3D printing, conformal coating, anodizing, passivation, electo-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 some 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 25% (domestic and international)
• Proven ability to mentor and develop technical team
• 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. multi-meter, oscilloscope, spectrum analyzer, logic analyzer, etc.)
• Ability to model in SolidWorks or Altium (or similar)

• Proven ability to mentor and develop technical team
• 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. multi-meter, oscilloscope, spectrum analyzer, logic analyzer, etc.)
• Ability to model in SolidWorks or Altium (or similar)