Job Description
RESPONSIBILITIES:
A Kforce client is seeking to hire a Mid to Sr. Manufacturing Engineer-Medical Device in Carlsbad, California (CA).
Summary:
The client is a growing and established Medical Device Technology company in the Carlsbad, CA area is seeking a couple of Mid-Level or Senior Manufacturing Engineers. We are working directly with the Hiring Manager on this exclusive search assignment. The company offers a competitive compensation package including base salary, annual bonus and stock/RSU's. You will be responsible for testing of new and existing products and development activities. This individual will be responsible for the development and testing electro-mechanical medical devices; Will work with a cross-functional team in a fast and dynamic environment. This position can be partial remote.
Responsibilities include:
* Define their manufacturing process, equipment, tools/fixture to ensure quality products are being delivered
* Oversee electro-mechanical processes
* Testing and building and designing custom test fixtures
* Provide technical support of the medical device products from the time it moves into manufacturing until the product has been completed
* 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.)
* Drive functional excellence initiatives for product/process and technical development
REQUIREMENTS:
* Bachelor's degree in Engineering preferably Mechanical, Electrical, Biomedical or similar field
* Six Sigma Certification
* 3-8+ years medical device experience in process/manufacturing engineering role preferably in Catheter or Console process development
* Experience with electro-mechanical processes
* A strong background in testing, building custom fixtures for either Catheter or Console (Monitor/Tablet) medical devices or similar electro-mechanical capital equipment
* Experience with designing of test fixtures, testing, and establishing test processes is required
* Experienced in supply chain, supplier process development/optimization
* CAD software experience such as Solid works or other CAD Software package
* Console Assembly/Electrical Assembly knowledge and/or experience
* Experience working in smaller fast paced environments is highly desired
* Experienced with implementation of new manufacturing processes and documentation is a plus
* Experience with sustaining and process engineering of the medical device products is a plus
* Experience with adhesive bonding and/or laser welding is a plus
* Experience with electronic and/or mechanical assembly is a plus
* Experience with the electronic and/or mechanical assembly of medical device products or medical equipment is a plus
* Understanding of medical device design controls/quality systems and product development processes is a plus
* Knowledge of FDA regulations and interpretation of FDA regulations, guidelines and policy statements is a plus
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.
A Kforce client is seeking to hire a Mid to Sr. Manufacturing Engineer-Medical Device in Carlsbad, California (CA).
Summary:
The client is a growing and established Medical Device Technology company in the Carlsbad, CA area is seeking a couple of Mid-Level or Senior Manufacturing Engineers. We are working directly with the Hiring Manager on this exclusive search assignment. The company offers a competitive compensation package including base salary, annual bonus and stock/RSU's. You will be responsible for testing of new and existing products and development activities. This individual will be responsible for the development and testing electro-mechanical medical devices; Will work with a cross-functional team in a fast and dynamic environment. This position can be partial remote.
Responsibilities include:
* Define their manufacturing process, equipment, tools/fixture to ensure quality products are being delivered
* Oversee electro-mechanical processes
* Testing and building and designing custom test fixtures
* Provide technical support of the medical device products from the time it moves into manufacturing until the product has been completed
* 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.)
* Drive functional excellence initiatives for product/process and technical development
REQUIREMENTS:
* Bachelor's degree in Engineering preferably Mechanical, Electrical, Biomedical or similar field
* Six Sigma Certification
* 3-8+ years medical device experience in process/manufacturing engineering role preferably in Catheter or Console process development
* Experience with electro-mechanical processes
* A strong background in testing, building custom fixtures for either Catheter or Console (Monitor/Tablet) medical devices or similar electro-mechanical capital equipment
* Experience with designing of test fixtures, testing, and establishing test processes is required
* Experienced in supply chain, supplier process development/optimization
* CAD software experience such as Solid works or other CAD Software package
* Console Assembly/Electrical Assembly knowledge and/or experience
* Experience working in smaller fast paced environments is highly desired
* Experienced with implementation of new manufacturing processes and documentation is a plus
* Experience with sustaining and process engineering of the medical device products is a plus
* Experience with adhesive bonding and/or laser welding is a plus
* Experience with electronic and/or mechanical assembly is a plus
* Experience with the electronic and/or mechanical assembly of medical device products or medical equipment is a plus
* Understanding of medical device design controls/quality systems and product development processes is a plus
* Knowledge of FDA regulations and interpretation of FDA regulations, guidelines and policy statements is a plus
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.