Job Description Summary

Job Description

• Develops, author and execute D&D plans, Design Verification, Design Validations and technical summaries for product design changes following the design control system. Performs DRD assessments for CTQ identification as part of this process.
• Proactively performs (leads) or participates in small (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. Reviews and approves process improvements and process changes by means of the change control process to ensure design intent is maintained (Design Control Engineering- DCE).
• Primary contact for basic questions related to product Engineering Specifications, Design Outputs, Product Design & Product Use of DR CC legacy products.
• Supports small (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 routine problem.
• Supports product stewardship, RA issues of legacy products and work on remediation projects, transfer knowledge in design control system, product use and design and overall technical knowledge. May be required to explain outcomes to and/or keep others who are performing related work informed. Perform other complementary and related duties.

Education and Experience:
Bachelor's Degree in in Engineering (Electrical, Electronic, Mechatronic, Chemical, Biomedical, Mechanical), Product Design or related Engineering discipline no experience Required

Additional Skills:
• Basic knowledge of GD & T (Geometric Dimensions & Tolerances) and a tolerance analysis.
• Basic knowledge in computer assisted design tools (AutoCAD, SolidWorks, ProE, etc).
• Basic process and product knowledge.
• Basic knowledge of Statistics (Yellow or Green Belt Certified)
• Knowledge in cGMP Manufacturing Environmental within Medical Device Industry, including knowledge of FDA / TUV guidelines and quality system regulations in general.
• Good computer skills in the use of MS Office Suite
• Basic documentation, communication (both written and verbal) and interpersonal relationship skills
• Basic knowledge of statistical techniques
• Good understanding and knowledge of principles, theories and concepts relevant to Engineering.
• Good problem solving, organizational, analytical and critical thinking skills
• Good knowledge of the processes and equipment used in the assigned work
• 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 apply company policies and procedures to resolve issues related to products/processes within an assigned team or work group.
• Ability to comply with the standards, regulations, procedures and quality manuals applicable
• 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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