Position Summary:
Provide process & product line support from prototype to manufacturing (may occur at ACIST or at one of our contract manufacturers), product end-of-life support and customer usage.
Support projects to improve product performance & reliability, reduce cost of goods sold.
Essential Duties and Responsibilities:
• Support new product development teams, help to define requirements, create processes and test systems, identify suppliers and ensure product meets customer and market expectations.
o Help create manufacturing processes, tools, fixtures, validation plans, project plans and change orders
• Help identify opportunities, lead projects and implement changes focused on improving product performance and reliability, increasing capacity and process capability while reducing scrap and throughput time.
o Support successful completion of project plans, coordinate project activities, set / adhere to milestones and action list
• Provide daily support of product lines and processes.
o Work closely with assemblers and technicians (at ACIST) or with contract manufacturers to provide guidance and share knowledge
• Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation.
• Support compliance to Regulatory Requirements.
Required Skills
EDUCATION:
- BS in Engineering (such as Electrical, Mechanical, Industrial, Chemical, Biomedical)
SKILLS AND ABILITIES REQUIRED:
- 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.
- Self-starter with good organizational, interpersonal, critical thinking, verbal and written communication skills.
- Flexible approach and ability to influence others.
- Familiarity with some manufacturing and secondary processes (i.e. PCBAs, electrical circuits, motors, sensors, switches, control systems, molding, machining, extruding, forming, welding, 3D printing, conformal coating, anodizing, electo-polishing, painting, etc.) and assembly operations (design for manufacturability).
PREFERRED SKILLS:
- Experience in medical device
- Familiarity of system requirements (i.e. GMP, QSR, GLP, CE, CSA, ISO, etc.)
- Agile / SAP (or similar documentation control / MRP systems)
- Capability to design, develop, prototype, validate and implement product and process improvements.
- Capability to identify required data, collect, consolidate and analyze for assessment, decision making and reporting.
- Familiarity of some problem solving and continuous improvement methodologies (PDCA, DMAIC, A3, 8D, CAPA, etc.)
- Familiarity of some 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)
- Familiarity of how to properly analyze data sets (i.e. ANOVA, student T, regression analysis, hypothesis testing, accelerated reliability testing, etc.) using statistical software (i.e. Minitab, JMP, LabVIEW, etc.)
- Familiarity with test instruments (i.e. multi-meter, oscilloscope, spectrum analyzer, logic analyzer, etc.)
- Ability to model in SolidWorks or Altium (or similar)
TRAVEL: <10%
Required Experience