Engineer/ Senior Engineer - Design

Job Description

Job Title:Engineer/ Senior Engineer - DesignLocation: Gurugram, IndiaJob Type: Full-timeSummary:A Design/ Mechanical engineering position in the R&D department with primary responsibilities of redesigning, maintaining, manufacturing transfer and cost reductions for an existing medical product used in surgeries. The engineer works closely with peers in design engineering, quality assurance and project and product management to develop product that meets customer and system requirements. Following defined design practices and the use of sound design engineering principles, the engineer ensures that the products are safe, robust and user friendly.Roles and Responsibility:

• Perform detailed design work and creation of drawings using Pro-E/Creo.
• Participate in DFM activities with AO & production vendors.
• Follow processes including concept design, supplier selection, testing, design finalization, verification, and validation activities.
• Communicate with vendors and other entities as needed
• Communicating effectively across all project disciplines and cross functional teams at global locations to ensure project team is aware of upcoming milestones and risks/issues.
• Occasionally Conduct static and fatigue stress analysis on developed designs using FEA
• Flexibility is essential as specifications may not be fully defined at the start of development, and liaison with customers for continued feedback and input of requirements is likely throughout the development.
• Identify root causes of issues, determines potential solutions, and evaluates them against requirements.
• Participate in task planning and estimating activities.
• Responsible for delivering his work in defined timelines while achieving product quality goals
• Documentation of work according to organization quality standards.
• Follows the companys standards for code development and quality process and complies with quality management system procedures.
• Ensures the integrity and security of patient health information, company intellectual property, and confidential data
• Well versed with global work environment and ability to work with cross functional teams located across globe.
• Good team player with high level of commitment and responsibility.

Desired Profile:The successful applicant should have an excellent design engineering background, good attention to detail, be self-motivated and effective in a team environment with multiple responsibilitiesEducation

• Bachelor of Technology in Mechanical Engineering, or Masters in related discipline.

Experience:

• Experience: 3 6 Years
• Preferrable years in similar role of product development or medical devices.

Required Technical Skill Set:

• Solid 3D CAD modeling skills (Pro-E/ Creo), generation of drawings for manufacturing & GD&T Fundamentals.
• Proficient in DFMEA, DFM/DFA, Tolerance Stack-up, Risk Analysis
• Product and Concept Design, Design Controls, Good knowledge of Machining and prototyping fundamental.
• Should have hands on experience on developing prototypes/ Test Method Failure models and writing the test protocols etc. along with defining verification and validation methods.
• Sound knowledge in material selection, especially materials specific to medical devices.
• Awareness about ISO13485 and International standards, and norms
• Knowledge of Change Control Procedures (ECR, ECN) and tools like 1Plm, Windchill or similar.
• Good Product Design & Development Experience particularly for medical devices.

Good to have Technical Skills:

• Good knowledge of medical regulatory standards and quality processes.

• Concept design and development and proofing by hand calculation, FEA reports
• Statistical Data Analysis Skills (Minitab)

Additional:

• Should be ready to travel to divisions as required.
• Effective interpersonal communications skills.
• Goal oriented and ability to work with cross functional teams.
• Ability to handle multiple projects at the same time.
• Demonstrated documentation skills, strong analytical & problem-solving skills.

Keyskills :
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