Manufacturing Engineer

The Manufacturing Engineer applies advanced engineering principles, technical expertise, independent judgment, and analytical problem-solving to design, develop, validate, and continuously improve manufacturing processes for precision medical-device components. The position independently evaluates manufacturing requirements, develops technical solutions, leads process improvement and validation activities, and provides engineering guidance supporting product quality, manufacturability, cost, and operational performance.

• →Minimum of 7 years of related experience in Manufacturing Engineering in a machining production and design facility.
• →Proficient with project planning; ability to effectively manage multiple projects; proven experience in leading process improvement projects required.
• →Experience in medical device manufacturing environment preferred.
• →Strong experience with planning, developing and conducting tests to validate machine and secondary processes.
• →Thorough understanding of raw materials, manufacturing processes, and quality control practices.
• →Extensive knowledge of CNC machining, tooling, processes and machining capabilities.
• →Advanced knowledge and understanding of blueprints and GD&T.
• →Knowledge of Statistical Process Control (SPC) is a plus.
• →Proficient in machine shop math.
• →Experience in ISO 13485 /FDA 21 CFR820 preferred.
• →Prior experience with CAPAs and complaints.
• →Ability to understand the technical attributes of a wide range of precision, mechanical products.
• →Strong root cause analysis skills and ability to identify complex problems and review related information to develop and evaluate options and implement solutions.
• →Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization.
• →Ability to work in a team environment, as well as, autonomously.
• →Capable of handling stressful situations and manage conflict.
• →Ability to read and comprehend complex instructions.
• →Maintain sense of urgency and ability to prioritize work.
• →Proficient in SolidWorks.
• →Computer literate in various software applications (i.e. Microsoft Office).
• →Experience leading a team of engineers.
• →Strong understanding of Lean Manufacturing and or 6 Sigma.
• →Strong customer service and communication skills with both internal and external customers.

• The noise level in the work environment is usually moderate.
• Work environment consists of time spent in both an office (50%) and manufacturing environment (50%).
• Includes potential exposure to sounds and noise levels that can be distracting or uncomfortable.
• Includes potential exposure to moving mechanical parts.
• Includes potential exposure to coolants and oils.
• Work environment is temperature controlled.

The work environment described here is representative of that which an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job the employee is regularly required to sit, stand or walk; use hands, handle, or feel objects, tools or controls; reach with hands and arms; talk and hear.
• The employee must be able to lift and/or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
• The employee must be able to sit or stand for up to 12 hours per day.
• Ability to function in highly stressful situations.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• Bachelor's degree in Engineering or a closely related engineering discipline required