Manufacturing Engineer in San Clemente, CA at Johnson Service Group

Date Posted: 12/18/2021

Job Snapshot

Job Description

JobID: 385760

Johnson Service Group is looking for a Manufacturing Engineer for our client in San Clemente.

This position is responsible for providing day-to-day support to production through root cause investigations and problem solving on issues related to material, process, tooling and equipment. Collecting and analyzing data on daily production processes to drive continuous improvement in manufacturing, and to drive efficiency. Work on workmanship standards and specification clarification to support increased yields in production.

Essential Job Responsibilities
  • Support product issues at incoming inspection as well as in process issues to resolve the issues such as non-conforming materials (NCMRs) and Corrective and Preventative Actions (CAPAs).
  • Evaluates manufacturing process by collecting production process data, input from operators and tooling capability for analysis to support process improvements
  • Improves manufacturing efficiency by evaluating process work flow and layout.
  • Support projects by calculating production, labor, and material costs; collecting timing studies, and estimating future requirements.
  • Identifies, develops and implements process improvements and strive for continuous improvement and cost reduction
  • First responder for production process issues; troubleshoots and resolves production line issues.
  • Evaluates, selects, installs production equipment as needed; troubleshoots equipment issues and coordinate equipment service as needed.
  • Responsible for process verification or validation activities related to daily production activities such as new equipment installation (IQ) or process qualification (OQ, PQ) for process improvements.
  • Includes fixture design, protocol development, execution, and operator training and report writing
  • Interfaces with vendors for incoming components and resolving process issues
  • Supports projects to utilize flow manufacturing concepts to improve quality, labor efficiency, and throughput.
  • Modifies manufacturing process documentation as needed including Manufacturing procedures, routers, drawings and inspection procedures as needed, and routes them through the Change Order process
  • Uses time management skills to meet deadlines
  • Protocol and report writing skills with strong statistical analysis capability
  • Complies with established Company and departmental policies and procedures, objectives, quality assurance program, safety and environmental standards.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Required Skills, Abilities & Technical Knowledge

  • GMP compliance in coordination with the Document Control, R&D, and Quality Assurance functions
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations including compliance to EN ISO 13485, Medical Device Quality Standards.
  • Ensure that all regulatory and internal policies are followed
  • Makes decisions in a timely manner, based upon a mixture of analysis, experience and judgment.
  • Resolve issues and overcomes obstacles to assure successful events. Use independent judgment to resolve unique challenges that arise with each event.
  • Support multiple activities to accomplish a goal; use resources effectively and efficiently while
  • adjusting to changing priorities in a start-up environment.
  • Determine the processes necessary to get things done; know how to organize people and activities to simplify complex processes.
  • Ability to establish, build and maintain professional working relationships with all levels of staff, clients, suppliers and the public.
  • Ability to work with minimal supervision.
  • Excellent interpersonal, verbal and written communication skills. Meticulous attention to detail and meeting deadlines.
  • Quality control, i.e., demonstrates accuracy and thoroughness and monitors own work to ensure quality.
  • Practice and advocate good safety skills at all times
  • Special projects will require extended work hours and some travel may be required

Education & Experience

  • B.S. in Engineering degree is required. A Mechanical Engineering degree is preferred.
  • Ideal candidate should have 5 to 15 years manufacturing engineering experience, preferably in the medical device field. Experience with catheter assembly, molding and secondary processing preferred.
  • Must possess good written and verbal English communication skills.
  • Intermediate level skill in Microsoft Word, Excel, Outlook and other office software programs.
  • Solidworks experience is a plus.
  • Knowledge of statistical methods of analysis
  • Working knowledge of inspection tools such as: calipers, micrometers, snap gage, microscope, tensile tester, VIS and pin gages.
  • Product testing experience (i.e. tensile testing, performance testing)
  • Experience with medical device manufacturing processes qualifications (IQ/OQ/PQ)

Environmental Conditions

  • Works in a Lab/Clean Room environment, within a well-lighted work area with good ventilation and normal noise levels from lab/shop equipment/Clean Room.
  • Frequent standing and/or walking; occasionally sit at desk and intermittently answer the telephone and write or use a keyboard to communicate through written means.
  • Some lifting up to 20 lbs. may be required.
  • Will require occasional travel both day trips and longer trips requiring overnight stays

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