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Industrial Automation Engineer

Frederick, MD

Posted: 05/05/2022 Industry: Operations Job Number: JN -032022-14309 Division: Life Sciences

Job Description

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Industrial Automation Engineer:

  • Title: Automation Engineer
  • Location: Frederick, MD
  • Industry: Pharmaceutical / Medical Device
  • Salary: Based on Experience
  • Employment Type: Direct Placement
Position summary:
Are you seeking a great opportunity that allows you to utilize your skills and experience across various engineering disciplines, which include Automation, Process Development and Production within the Operations division? Do you have experience in developing and validating automation processes for full scale manufacturing? Do you enjoy collaborating with others to create and enhance, validate, evaluate, and implement process/product design and development? We are seeking an experienced and dynamic automation engineer who will assist with supporting and resolving production process issues by analyzing data, investigating issues, identifying solutions, and implementing resolution.

Essential Functions:
  • Develop and deliver validated and reliable automated manufacturing processes for full-scale manufacturing, according to business requirements.
  • Work with the R&D, Product Development, Quality, Electrical and Mechanical engineering teams to contribute to process/product design and development. Constructively review designs to ensure quality, efficiency, and optimal cost of products in Production both at company and at contract manufacturing facilities.
  • Write and maintain DMR / DHF technical documentation to ensure manufacturing processes, equipment and facilities are introduced in accordance with company s QMS.
  • Plan and complete the purchase, introduction and implementation of equipment, jigs, and tooling, in line with requirements for Production ramp-up volumes and timing.
  • Resolve Production issues by analyzing data, investigating issues, identifying solutions, and implementing resolutions (i.e., NCRs, Deviations).
  • Perform verification and validation activities including Test Method Validation, PFMEAs, Gage R&R, risk assessments, facility / equipment / process validation (IQ, OQ, PQ) for medical devices within a manufacturing environment.
  • Seek, evaluate, analyze, and implement process improvements to reduce cost and/or improve efficiency.
  • Provide adequate training of Production staff during process development activities, documenting training accordingly.
  • Support and resolve Production process issues by analyzing data, investigating issues, identifying solutions, and implementing resolutions (i.e., NCRs, Deviations).
Work Experience and Skills:
  • Minimum 2 years of industry experience in Process Development / New Product Introduction / Production Engineering, or equivalent, within a regulated environment (medical/automotive/defense etc.)
  • Experience troubleshooting issues with complex systems working methodically through the fault-finding process and where necessary document the process and correction.
  • Experience in design and development of automated manufacturing equipment.
  • Experience with introducing automated manufacturing equipment into production.
  • Experience with PLCs for de-bugging purposes.
  • Experience in working and fault finding of automated manufacturing equipment (i.e., conveyors, bowl feeders, any feeders, tape, and reel).
  • Proven competencies in problem solving and developing/optimizing processes.
  • Experience with introducing manufacturing equipment into production.
  • Experience with creating documentation (WINs/SOPs), risk analysis and validation activities.
  • Experience in delivering training to Production staff.
  • Experience working with a Quality Management System.
  • Excellent written English and documentation skills.
  • Knowledge of ISO 13485 Medical Device standard.
  • Process development and validation experience in the medical device industry; IQ, OQ, PQ.
  • Experience with Allen-Bradley PLCs for de-bugging purposes.
  • Knowledge and experience of working with Fanuc and Kuka robotics.
  • Knowledge and experience of working with Cognex cameras.
  • Knowledge and experience of working with OPC servers (i.e., Kepware)
  • Experience working with an ISO certified change management process.
  • Knowledge of Lean Manufacturing principals.
  • Experience in high volume manufacturing.
Education and Qualifications:
  • Bachelor s Degree in Mechanical / Electrical / Electronics / Mechatronics
  • Engineering or equivalent
  • Master s Degree in Mechanical / Electrical / Electronics / Mechatronics
  • Engineering or equivalent
  • Lean Six Sigma (LSS) Yellow, Green or Black Belt Qualifications
  • Design for Manufacturing and Assembly (DFMA)

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
EOE/ADA

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