Sr. R&d Mechanical Engineer

hace 2 semanas

Mexicali, México Spark A tiempo completo

Operating Company: Spark
Location: Mexicali,Baja California,MX
Date Posted: March 13, 2024
Req Number: R5019155

Sr. Mechanical Engineer will be responsible for supporting existing products and tasked to support ongoing product improvements and compliance activities including design changes, INNOVATION, CAPAs, VAVE, PPV and general product support activities such as qualification of alternate suppliers/materials related to component end of life. The Sr. Mechanical Engineer should have understanding and experience in medical device products, CNC machinery and design control processes. The position requires excellent team skills, understanding of CNC, 3D, Automation, manufacturing, problem solving skills and solid background in R&D and production.

**Primary Duties and Responsibilities**:

- R&D, Innovation in process improvements, change control, material review, CAPA, PMS and complaint reduction processes.
- Performing root cause analysis for product/process defects
- Generate engineering solutions by evaluation and selection of optimum design alternatives.
- Utilize project planning and monitoring methods to ensure timely completion.
- Develop design and products performance specification requirements.
- Help Maintain Design History Files in accordance with established Company's Product Development Process
- Planning and executing production changes
- Conduct basic study of current processes
- Perform basic engineering analyses such as materials, root cause analysis and FMEA
- Lead or conduct analysis and experiments to evaluate designs or processes.
- Translate analysis and experimental results into design criteria.
- Participate in tasks such as regular planning events, Partner communications between manufacturing & R&D, and resource coordination.
- Prepare time studies, cycle time, and cost estimates on proposed new products.
- Participate in design transfer activities
- Provide technical presentation support and consultation to internal/external customers.
- Recommend the addition, expansion or termination of current processes for technical soundness of current & future engineering programs.
- Participate, as needed, in efforts associated with continuous improvement, regulatory compliance, and other organizational capability initiatives

**Job Requirements**:

- BS in Mechanical engineering or related engineering disciplines, and at least 2 years of relevant R&D, Manufacturing, and Innovation experience are required. Knowledge of CNC production is a plus.
- Minimum of 3 years of product development work and/or design update experience.

**Preferred Qualifications**:

- Good problem solving and decision-making capabilities
- Prior experience with development/design controls and manufacturing
- Prior hands on experience working with CNC manufacturing
- Basic knowledge of relevant manufacturing processes and materials
- Proficient in statistical evaluation of process data (Minitab a plus)
- Familiarity with appropriate design controls, regulatory approval methods
- Familiarity with FMEA techniques, BOM structuring, test protocol writing, validations, verification testing, quality inspection methodology, and report writing
- Ability to work with a mix of technologies.
- Basic knowledge of Anatomy, Physiology, and Biomechanics is preferred.
- Process improvements regards equipment and process.
- SolidWorks’ skills
- Machining skills

**Operating Company**:
Spark

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