Mid-Sr Catheter Manufacturing Engineer

RESPONSIBILITIES:
Kforce has a client that is seeking a Mid-Sr Catheter Manufacturing Engineer in Carlsbad, CA.

Responsibilities:
* Create and implement new manufacturing processes for new and current disposable medical devices
* 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.
* Support production on both sustaining activities and new products development from line setup through commercialization
* Support production and own NCR, CAPA, and/or investigations
* Innovate, design, and develop processes, procedures, tooling and/or automation
* Train and provide guidance to manufacturing personnel and product technicians
* Drive functional excellence initiatives for product/process and technical development
* Other duties as assigned

REQUIREMENTS:
* Bachelor's degree in Engineering required, preferably Mechanical or Biomedical
* 3+ years of medical device experience in process/manufacturing engineering role
* 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
* Experience in a regulated environment; Preferably medical device
* Understanding of medical device design controls / quality systems and product development processes
* Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines and policy statements
* CAD software ex. Solidworks
* Excellent verbal/written communication skills
* Ability to organize, records, and implement procedures

The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.

We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.

Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.

This job is not eligible for bonuses, incentives or commissions.

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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