Job Summary: 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.
Qualifications
Bachelor's degree (BS) in engineering or equivalent combination of education and experience
Minimum 3 years engineering experience in a manufacturing environment
Experience working in a GMP, FDA, ISO, and USDA regulated environment preferred
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 general public
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
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 architectures is required, including Programmable Logic Controllers (PLC's), Human Machine Interfaces (HMI), Motion Control, Robots, and Vision Systems
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, hand and power tools
Must be able to meet deadlines while working on multiple projects
Familiarity with cGMP and ISO 13485 regulations and practices is desired
Familiarity with a variety of material testing and measuring methods
Ability to travel up to 10% of the time
Responsibilities:
Process development, equipment specification, acquisition and implementation.
Evaluation of machine logic and controls to 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.
Suggests and supports 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, and 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 process as necessary
Actively participates in teams as necessary to ensure continual improvement, safety and compliance
Lead cross functional project teams and coordinate activities.