Job Title: Manufacturing Controls Engineer

Location: Onsite Scarborough, Maine

*OK with working off-shift hours (second shift 2-10pm) after 6 weeks of working normal day shift.

*Need 1 verifiable Manage reference (w/ LinkedinPage)

RESPONSIBILITIES:

Process development, equipment specification, acquisition and implementation.

Evaluation of machine logic and controls to troubleshoot equipment and identify process improvement opportunities.

Supports on-site production and maintenance activities with advanced latter logic troubleshooting abilities

Serves as a steward of the internal QMS management system for change management (Oracle's Agile PLM)

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

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

BASIC QUALIFICATIONS | EDUCATION:

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

Previous experience with common manufacturing automation technologies and architectures is required. This includes but is not limited to:

Programmable Logic Controllers (PLC's) (Allen Bradley Logix5000 experience preferred)

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 preferred)

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 to include lens and lighting selection.

Ability to create robust inspection logic for the disposition of product.

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 electrical prints to support controls upgrade and integration.

PREFERRED QUALIFICATIONS:

Experience working in a GMP, FDA, ISO and USDA regulated environment.

Familiarity with cGMP and ISO 13485 regulations and practices.

Familiarity with statistical analysis software (Minitab).