Senior Manufacturing Engineer

Company Name:
Breg provides premium, high-value sports medicine products and services that advance orthopedic patient care. From pioneering cold therapy products and innovative bracing to caring customer service and award-winning orthopedic practice solutions, Breg delivers a 360customer experience unmatched in the industry.
Founded in 1989, Breg offers cold therapy, knee, shoulder, spine, elbow/wrist, foot/ankle bracing and orthopedic practice solutions. The Companys products are sold through more than 100 distributors in 36 countries. Breg is based in Carlsbad, CA.
We currently have a full time opening for a Senior Manufacturing Engineer at our Carlsbad, California headquarters.
In this role, the Senior Manufacturing Engineer provides Manufacturing and Sustaining Engineering support to existing production lines, and manages engineering projects such as capital equipment, cost reduction and Quality improvement initiatives.
Work in a multifunctional team environment to ensure existing production lines are fully supported:
o Develop, document and validate production equipment, tools and fixtures.
o Work with external suppliers to develop and validate plastic injection molds and other capital equipment.
o Develop, document and validate Manufacturing processes.
o Provide Sustaining Engineering support (cost reduction, quality improvement, EOL, etc.).
Work in a multifunctional team environment to develop new products and transfer them to production:
o Actively participate in the design process to ensure new product designs are Lean and robust.
o Develop, document and validate production equipment, tools and fixtures.
o Develop, document and validate manufacturing processes.
o Coordinate Pilot Line transfer to production.
Create project plans and ensure projects are completed within the budget and on schedule.
Ensure that all engineering documentation and manufacturing processes comply with FDA QSRs and established company procedures.
Perform other tasks as required.
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the companys policies and practices.
Responsible for taking accountability to demonstrate the organizations Cultural Beliefs and achieving desired results.
Responsible for driving the Culture within the organization by using tools such as storytelling, focused feedback, and recognition. Performance is aligned with the Culture of Accountability - See It, Own It, Solve It, and Do It. All employees are expected to know and understand Bregs Cultural Beliefs.
Bachelors in Science degree (BS) or related major from an accredited college or university or equivalent combination of education and experience is required.
Minimum seven years engineering experience in a manufacturing environment, preferably with experience in the following areas:
o Experience in injection molding, plastics, metal forming and cutting
o Six sigma / Lean Manufacturing / Continuous Improvement
o Design For Manufacturability, Lean Design, House Of Quality (HOQ)
Strong working knowledge of FDA Quality System Regulations (QSR) International Standards Organization (ISO).
Medical device manufacturing of Class I & II products a plus.
Experience in the design, test and validation processes and procedures for new products.
Design control and configuration management as it pertains to Sustaining Engineering.
Experience supporting the introduction of new products into Manufacturing.
Demonstrated competency related to assembly, bonding, metal forming, sewing, cutting and machining, plastics molding and ability to design manufacturing processes with these technologies.
Experience with the documentation requirements for new and existing products including bills of material, change orders, component documents, and tooling.
Bi-lingual in Spanish is preferred.
Previous experience with Maquilladora operations is preferred.
Previous supervisory experience preferred.
If you meet the requirements above and would like to apply for this position, please visit our website at www.breg.com and click on the Careers section.
Breg is an Equal Employment Opportunity Employer and dedicated to a diverse work force and Drug Free work environment. EOE/Minorities/Females/Vet/Disabled are encouraged to apply.

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