Lead Manufacturing Engineer - Medical Device
Kforce Inc.

Carlsbad, California


RESPONSIBILITIES:

Kforce's client, a growing Medical Device Company in Carlsbad, CA, is seeking a couple of Lead Manufacturing Engineers within the Medical Device Industry. We are working directly with the Hiring Manager on this exclusive search assignment. This company offers a competitive compensation package including base salary and annual bonus. One of the positions would be for the Console group and the other one for the Catheter group.Summary:The Lead Manufacturing Engineer will lead and support new product and development activities. This individual will be responsible for the design, development, implementation, and control of new and improved manufacturing processes for medical devices. The Lead Manufacturing Engineer will provide daily support of products, processes, materials/supplier management, and equipment for new and sustaining products. This individual will work with a cross-functional team in a fast and dynamic environment.Responsibilities:
  • Create and implement new manufacturing processes for new and current disposable medical devices or Consoles
  • Work with suppliers around the world to understand and define their manufacturing process, equipment, tools/fixture to ensure quality products are being delivered
  • Perform characterization, Design of Experiments (DoE), and write/perform validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ)
  • Create manufacturing documentation including work instructions, forms, BOMs, routers, FMEAs, DMR, and DHF documents, etc.)
  • Work with other engineers and technicians on business activities for manufacturing
  • Innovate, design, and develop processes, procedures, tooling and/or automation
  • Train and provide direction to direct reports and manufacturing personnel
  • Drive functional excellence initiatives for product/process and technical development


REQUIREMENTS:

  • Bachelor's degree in Engineering preferably Mechanical or Biomedical or similar field
  • Six Sigma certification
  • 5-10+ years of medical device experience in process/manufacturing engineering role with either Catheters or other disposable devices and/or Consoles or similar capital equipment
  • Lead experience is a plus
  • Experience in Design for Manufacturing (DFM), Lean Manufacturing, Design of Experiments (DoE), technology/process transfer experience, product/process failure mode and effects analysis (FMEA), and problem-solving methodologies
  • Experienced with creation and implementation of new manufacturing processes and documentation for disposable medical devices
  • Knowledge of adhesive bonding and/or laser bonding
  • Experienced in supply chain, supplier process development/optimization
  • Understanding of medical device design controls/quality systema and product development processes
  • Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines, and policy statements
  • CAD software example: Solid Works
  • Excellent verbal/written communication skills
  • Highly self-motivated individual with a collaborative determination to achieve set goals
  • Ability to organize, records, and implement procedures
  • Experience with catheters is a plus
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.



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