What are the responsibilities and job description for the Manufacturing Engineer - Medical Device position at Kforce Technology Staffing?
Job Details
RESPONSIBILITIES:
Kforce's client, a growing and innovative Medical Device Technology Company is seeking a Manufacturing Engineer in Carlsbad, CA. We are working directly with the hiring manager on this search assignment. The Manufacturing Engineer is responsible to lead and support sustaining and new product development activities on the disposable catheter and accessories. This individual will provide daily support of products, processes, materials/supplier management, and equipment for new and sustaining products.
Responsibilities:
* Create and implement new manufacturing processes for new and current disposable medical devices
* Creation and implementation of new processes, equipment/fixture, tools, and documentation
* 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
REQUIREMENTS:
* Bachelor's degree in Engineering required, preferably Mechanical, Manufacturing, Biomedical or similar field
* At least 3-5 years of medical device experience in process/manufacturing engineering role
* Experience in a regulated environment; preferably medical device
* Experience with disposable medical devices such as catheters or similar devices
* 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 with CAD software such as Solid Works or similar CAD Software Package
* 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
* 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.
By clicking ?Apply Today? you agree to receive calls, AI-generated calls, text messages or emails from Kforce and its affiliates, and service providers. Note that if you choose to communicate with Kforce via text messaging the frequency may vary, and message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You will always have the right to cease communicating via text by using key words such as STOP.
Kforce's client, a growing and innovative Medical Device Technology Company is seeking a Manufacturing Engineer in Carlsbad, CA. We are working directly with the hiring manager on this search assignment. The Manufacturing Engineer is responsible to lead and support sustaining and new product development activities on the disposable catheter and accessories. This individual will provide daily support of products, processes, materials/supplier management, and equipment for new and sustaining products.
Responsibilities:
* Create and implement new manufacturing processes for new and current disposable medical devices
* Creation and implementation of new processes, equipment/fixture, tools, and documentation
* 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
REQUIREMENTS:
* Bachelor's degree in Engineering required, preferably Mechanical, Manufacturing, Biomedical or similar field
* At least 3-5 years of medical device experience in process/manufacturing engineering role
* Experience in a regulated environment; preferably medical device
* Experience with disposable medical devices such as catheters or similar devices
* 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 with CAD software such as Solid Works or similar CAD Software Package
* 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
* 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.
By clicking ?Apply Today? you agree to receive calls, AI-generated calls, text messages or emails from Kforce and its affiliates, and service providers. Note that if you choose to communicate with Kforce via text messaging the frequency may vary, and message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You will always have the right to cease communicating via text by using key words such as STOP.
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