Engineer I

Job Description

• Bachelor's Degree in Engineering or Scientific field Required with 2-3 yrs exp

• Good computer skills in usage of MS Office Suite; CAD experience preferred
• Good documentation, communication (e.g., written and verbal), and interpersonal relationship skills including consultative and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required (if applicable)
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical, and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships
• 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 the environment and prevention of pollution under their span of influence/control
• Basic knowledge of GD & T (Geometric Dimensions & Tolerances). Basic knowledge of tolerance analysis.
• Basic knowledge of computer assisted design tools (AutoCAD, SolidWorks, ProE, etc) is desirable.
• Technical savvy and writing.
• Ability to develop innovative and pragmatic solutions to a variety of problems of small scope and complexity in a fast-paced environment.
• Contributes to the completion of small/medium portions of organizational projects and goals.
• Level of supervision: work is reviewed while in process, including upon completion of project milestones.
• Builds working relationships with assigned and allied teams.
• Results oriented based on commitments.
• Basic communication & presentation skills.
• Compares and evaluates possible courses of action after considering various possibilities.
• Predictable and reliable.
• Adaptable to change.
• Sense of urgency.

• Applies knowledge of technical principles and Edwards's systems/procedures to optimize maintain and improve the design of CC legacy products while following design control system guidance.
• Develop basic experiments and tests (including writing and executing D&D plans, Design Verification, Design Validation, and technical summaries for product design changes following the design control system. Performs DRD assessments for CTQ identification as part of this process) to qualify and validate design changes; analyze results, make recommendations, and develop reports
• Establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis)
• Generate work instructions, test methods, engineering drawings/prototypes, etc. to establish/characterize the product and/or process specifications
• Create/update portions of design control documents including requirement specs and risk documents
• Assign R&D support tasks; gives instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
• Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for supply-to-dayparts day-to-day requests/activities requiring R&D assessments and approvals from the DR Plant mainly traduced in ECRs, t, technical summaries, and protocols. Reviews and approves process improvements and process changes using the change control process to ensure design intent is maintained (Design Control Engineering- DCE).
• Analyzes data and interprets standard practices and procedures to establish problem-solving for problem-solving. Develops solutions to the routine problem.
• Comply with the standards, regulations, procedures, and quality manuals applicable to Edwards Lifesciences.

• Other duties assigned by Leadership
• Not Entry level
• Someone with Exp, not intermediate Technical
• Validations
• Data Analysis
• Medical Device
• Technical Writing
• team building
• ability to work with other/partnerships
• Self-motivated
• ability to have critical thinking skills
• communication
• ability to resolve issues
• ability to accept constructive criticism