Job Description Summary

Provides support for manufacturing processes, validation and implementation of changes in processes and products, updating manufacturing methods.

Job Description

Key Responsibilities:
• Develops, author and execute D&D plans, Design Verification, Design Validations and technical summaries for product design changes following the design control system and using statistical tools. Performs DR assessments for CTQ identification as part of this process.
• Proactively performs (leads) or participates in small to moderate (in complexity and technical depth) product design changes to DR legacy products to improve design for manufacturability, product cost, product quality, product testing and for business continuity purposes (DFX).
• Supports day to day requests/activities requiring R&D assessments and approvals from the DR Plant mainly traduced in ECRs, technical summaries and protocols. Review and approve process improvements and process changes by means of the change control process to ensure product design intent is maintained (Design Control Engineering- DCE).
• Supports small to moderate (in complexity and technical depth) Value Improvement Projects (Cost Savings and Value Engineering) and Material Projects (Business Continuity). Validates like for like (functional) design changes.
• Analyzes data and interprets standard practices and procedures to establish recommendations for problem solving. Develops solutions to a variety of problems of moderate scope and complexity.
• Supports product stewardship, RA issues of legacy products and work on remediation projects. Perform other complementary and related duties.

Education and Experience:
Bachelor's degree in engineering (Electrical, Electronic, Mechatronic, Chemical, Biomedical, Mechanical), Product Design or related Engineering discipline, 2 Years experience of previous experience, required
Master's Degree or equivalent in plus internship, senior projects, thesis in Engineering or Scientific field, Product Design, preferred

Additional Skills:
• Good computer skills in the use of MS Office Suite
• Moderate knowledge in Statistic Tools Management (DOE, Six Sigma, Green Belt Certified, etc.)
• Moderate knowledge in computer assisted design tools (AutoCAD, SolidWorks, ProE, etc)
• Basic understanding of statistical techniques
• Basic knowledge of JD Edwards.
• Good knowledge of GD & T (Geometric Dimensions & Tolerances) and a tolerance analysis.
• Good documentation, communication (for example, written and verbal) and interpersonal relationship skills, including consulting skills and relationship management
• Knowledge in cGMP Manufacturing Environmental within Medical Device Industry, including knowledge of FDA / TUV guidelines and quality system regulations in general.
• Solid understanding and knowledge of principles, theories, concepts, practices, and standards
• Solid problem solving, organizational, analytical and critical thinking skills
• Strict attention to detail.
• Ability to interact professionally with all organizational levels.
• Ability to manage competitive priorities in a fast-paced environment.
• Ability to work in a team environment, including the ability to manage suppliers and project stakeholders.
• Ability to build productive internal / external productive relationships.
• Ability to comply with the standards, regulations, procedures and quality manuals applicable to Edwards Lifesciences.
• Ability to demonstrate good judgment in selecting methods, techniques for obtaining solutions, analytical and critical thinking skills.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Required Skills

Optional Skills

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Primary Work Location

DOM Santo Cristobal - Nave 25-Merengue

Additional Locations

Work Shift