This position has seasoned understanding and knowledge of engineering concepts, practices and procedures and can apply them accordingly. Can independently investigate, recommend, and, with oversight, deploy new and/or improved technologies to improve product quality and/or reduce manufacturing costs. Effective in fast-paced and highly multitasked situations. Target-oriented approach and driven to achieve results.

• Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; consulting with equipment vendors and observations from operators.
• Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment.
• Writes cGMP documentation (SOPs, WI, change controls, FMEA, validation protocols, etc.) 
• Performs quality/safety investigations, and risk evaluations. Owns and executes Quality and Safety CAPAs. 
• Improves manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
• Assures product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes.
• Provides manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules to estimating future requirements.
• Provides manufacturing engineering information by answering questions and requests.
• Keeps equipment operational by supporting Reliability, Automation, and Maintenance; following manufacturer's instructions and established procedures.
• Completes design and development projects by training and guiding technicians.
• Finalizes drawings and specifications for new manufacturing equipment or modifications to existing equipment, following established Engineering guidelines for content and format.
• Supports efforts to set standards for machine/equipment specifications, designs, buyoff criteria, drawings, and other as-required documentation.
• Resolve causes of manufacturing process problems and update processes and/or procedures to reflect continuous improvement.
• Responsible for the planning, project management, purchasing, installing, runoff and commissioning of manufacturing equipment and processes.
• Provide guidance to Mfg. Engineer - Level I and others as needed.

• Bachelor’s Degree in Mechanical Engineering (or related college degree) and 3-5 years engineering experience or 8 years of relevant experience.
• Word, Excel, Access, Project, CAD (preferably 3D or Inventor).
• Knowledge of parts manufacturing equipment and processes; automated and manual assembly processes; tooling, die and fixture design; engineering mechanics, heat transfer, electrics and electronics, hydraulics, pneumatics; control system principles and equipment, and statistical process control.
• Demonstrated knowledge of high mix/volume manufacturing methods, procedures, and cost-reduction techniques in a Lean environment; working knowledge of Lean Manufacturing tools: including 5S, Value Stream Mapping, Standard Work, Pull Systems, Cellular Manufacturing and Kaizen events.