SUMMARY

Primary focus will be on the development, characterization, optimization, validation, and production support of manufacturing and test equipment utilized for the manufacture of consumable devices. Familiarity with medical devices and web based technologies in an FDA environment are relevant experiences which apply to this position.

TECHNICAL SKILLS
• Ability to champion changes across Research and Development and Operations
• Proven track record in the use of Design Of Experiments (DOE) methods to characterize and optimize manufacturing processes
• Expertise in machine control design including electrical schematics, and electrical panel drawings
• Writes detailed protocols to meet quality system requirements and regulatory submissions
• Expertise in developing Programmable Logic Controllers (PLC) and Personal Computer (PC/e.g. OPTO22) based machine control and Human Machine Interface (HMI/e.g. Visual Basic) software
• Expertise in developing machine vision applications (Acuity, Cognex, Sherlock, DVT) for the registration and inspection of intermediate and final device manufacture
• Expertise in designing complex mechanical systems in a parametric CAD system such as SolidWorks, SolidEdge, Pro Engineer, etc.
• Expertise in creating detail mechanical drawings including Geometric, Dimensioning & Tolerancing (GD&T) standards
• Expertise in creating machine pneumatic diagrams
• Experience in developing and implementing process and software validation plans
• Demonstrated ability to fully develop machine documentation packages including I/O lists, Bills of Materials (BOM), machine operating procedures, preventive maintenance, etc.
• Experience in punch die design

PROJECT MANAGEMENT SKILLS
• Ability to effectively collaborate in a multi-functional project team environment
• Excellent verbal and written communication
• Experience in developing and managing work plans (Gantt charts)
• Proven track record in successfully coordinating, suppliers in the fabrication and integration of machine components, assemblies, and systems. Demonstrated on-schedule and within budget performance is critical
• Ability and desire to expand one's technical and leadership skills in an effort to continually increase one's contribution to the company's goals and objectives
• Ability to write acceptance criteria for an automation system

Ability to manage a vendor to design, fabricate, and test a new automation system which can be integrated into our production floor. This involves concept reviews, maintaining schedules, hosting meetings and design reviews

SUPERVISORY RESPONSIBILITIES

This position must be able to work closely with production and maintenance to install new equipment and keep it running. This involves identifying resources needed, assembling / managing sub-groups to solve machine issues, and leading vendors through any machine improvement designs as separate projects. Also, directly supervise and arrange subordinate supervisors and non-supervisory employees.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

B.S. in Mechanical Engineering, Industrial Engineering, or Electrical Engineering. The candidate must have 10 years of experience in designing and developing complex automation cells for prototype and production process equipment.

LANGUAGE SKILLS

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors. Ability to write clear, concise reports and procedures

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

CERTIFICATES, LICENSES, REGISTRATIONS

None required. Six Sigma or Lean Manufacturing a plus

PHYSICAL DEMANDS

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 the essential functions.

While performing the duties of this job, the employee is frequently required to stand; use hands to finger, handle, or feel; and talk or hear. The employee is occasionally required to walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those 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 frequently exposed to fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to moving mechanical parts. There is a risk of electrical shock.

The noise level in the work environment is usually very loud in the production area.