Vacantes Co-Production

Manufacturing Engineer / Ingenierio Manufactura


smiths interconnect

I. Job Summary
The Manufacturing Engineer will interface between R&D and Operations during new product development programs; primarily to ensure the supplier/s is fully capable of meting AMP's product expectations. This includes establishing part validation & test parameters, then performing and documenting these tests accordingly prior to their approval and use. This person will also work on current products to streamline these where possible, in order to reduce costs, either in the process and/or the part/s. Finally, this position will support the company's quality management system in establishing sound documentation practices.



II. Essential Duties/Responsibilities
- Manage ECO process to ensure all parties at Aspen have all the information they need prior to product release and/or changes and then subsequent BOM release and/ or changes.
- Interface with R&D on the implementation of new products at vendor locations
- Monitor manufacturing specifications, identify product and process metrics and report on product quality performance trends
- Oversee the qualification of new products into manufacturing through product release; support the implementation of new quality procedures and process controls. Develop a process for this.
- Work with purchasing to qualify new vendors; cost reductions in manufacturing and the supply chain
- Implement testing program both for R&D and production parts – pre and post qualification; develop validation plans and protocols for parts, processes and equipment
- Implement process control procedures in Irvine and at supplier locations for manufacturing; assembly line design optimization and Kaizen activities
- Support the design and procurement of fixturing in manufacturing
- Support the design and procurement of fixturing in manufacturing
Supplier validations/production line reviews/process improvements
- Sustaining engineering of outsourced products; Component consolidation/reverse engineer products
- Sustaining engineering of outsourced products; Component consolidation/reverse engineer products
Establish drawing requirements with correct material specs for Ops and R&D



III. Education/Work Experience
- BS degree is required
- Five plus years (5+) in a GMP or ISO 13485 regulated Medical Device manufacturing environment.



IV. Knowledge/Skills
List special technical or other skills/knowledge required as a minimum qualification for this job:

- Knowledgeable of GMP and ISO 13485 quality system requirements; also FDA Validation Guidelines.
- Good problem solving skills; CAPA and root cause analysis.
Lean Manufacturing, 6 Sigma, DFM, DFSS and other Quality Tools
- Experienced in the use of Risk Management tools such as FMEA, FTA, etc.
- Excellent ability to write procedures and test documentation
- Broad engineering experience in manufacturing operations, including new product development, cost reduction, process qualification, and quality engineering; project management experience
- Experienced in identifying, proposing, and leading in quality system improvement initiatives and projects.
- Ability to work independently, as well as with others.
- Able to multitask, handle multiple projects at one time, and change priorities based on business needs
- MS office computer skills required - Word , Excel, PowerPoint
- Drawing skills; fluent in AutoCAD or other design software


V. Additional Comments
Bilingual (English & Spanish) would be a plus for this position
Ability to create manufacturing fixtures to aid production
Knowledgeable in Adobe Photoshop and Illustrator a plus
This job will require some traveling both domestically and international (up to 10% of job)



Referencia :
Contrato :
Vacante(s) :
Experiencia :
3~5 Años
Nivel de Estudio :
Carrera Profesional
Lugar :
Smiths - Tijuana, Baja California
Creado :
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  • Parque Industrial Thomas Alva Edison
    Blvd. Corredor Tijuana-Rosarito 2000, 15202
    Int. Mt8-10,11 Y12, Zona Cerril General
    C.P. 22330, Tijuana, Baja California, Mexico
  • +52(664)454-3330
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