Job Summary:

This role will be responsible for supporting product development from concept through sustained manufacturing of FDA-regulated products. Completion of process development, equipment acquisition and leadership of supporting development partners. Experience with manufacturing processes, quality/cost savings initiatives and implementation of engineering principles while assuring compliance with cGMP, quality, and safety standards.

Job Responsibilities:

• Process development, equipment specification, acquisition, and implementation.
• Evaluation of machine logic and controls troubleshoot equipment and identify process improvement opportunities.
• Integration of controls hardware and software into new and existing manufacturing equipment.
• Design of experiments, validation, completion of testing and analysis of data.
• Suggest and support new methods or materials for continual improvement of quality and efficiency.
• Analyzes current equipment for process suitability and provides detailed plans for improvement.
• Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, procedures and other technical documents to ensure compliant, efficient, and safe procedures.
• Works with other engineers and technicians in developing solutions and improvements in materials, equipment, and processes as necessary.
• Actively participates in teams as necessary to ensure continual improvement, safety and compliance.
• Lead cross-functional project teams and coordinate activities.

Measures of Performance:

• Appropriate process and equipment definition.
• Quality of communication and documentation
• Time management and project metrics.
• Implementation of core engineering principles.

Qualifications:

Required:

• Bachelor's degree (BS) in engineering or equivalent combination of education and experience.
• Minimum 3 years of engineering experience in a manufacturing environment
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
• 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.
• 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.
• Previous experience with common manufacturing automation technologies and architecture is required.
• Must be able to work on problems of diverse scope where analysis of the problem requires evaluation of obscure or unknown data.
• Must be able to use precision measuring equipment, and hand and power tools.
• Must be able to meet deadlines while working on multiple projects.
• Programmable Logic Controllers (PLC’s) (Allen Bradley Logix5000 experience
  • Ability to read and troubleshoot existing ladder logic.
  • Ability to generate new ladder logic for the sequencing of complex manufacturing tasks.

• Human Machine Interfaces (HMI) (Allen-Bradley Factory Talk View experience
  • Ability to modify and troubleshoot existing user interfaces.
  • Ability to design and implement new user interface functionality.
• Motion Control to include Servo Drives, VFD’s and Stepper Drives.
  • Ability to troubleshoot and tune control loops.
• Robots (Staubli and/or Epson experience preferred)
  • Ability to modify robot programs and taught positions.
  • Ability to sequence new robot paths and functions.
• Vision Systems (Cognex and/or Keyence experience preferred)
  • Ability to troubleshoot existing vision inspection applications.
  • Ability to design new systems that include lens and lighting selection.
  • Ability to create robust inspection logic for the disposition of products.
• Electrical Aptitude
  • Ability to read and trace machine control systems from electrical prints.
  • Ability to troubleshoot common machine control hardware (relays, fuses, breakers, etc.)
  • Ability to generate and modify electricity.

Preferred:

• Experience working in a GMP, FDA, ISO, and USDA regulated environment.
• Familiarity with cGMP and ISO 13485 regulations and practices is desired.
• Familiarity with a variety of material testing and measuring methods.