Job Summary

Sr. Design Engineer (Mechanical Design)

Position Description

Provide Engineering Leadership at IZiel for medical device development, product lifecycle from gap assessment, engineering documentation, process validation (IQ, OQ, PQ, TMV, TMD) to acquisition & integration of projects for medical device companies. Project management responsibilities include the coordination and completion of projects on time within budget and within scope. Oversee all aspects of projects, set deadlines, assign responsibilities and monitor and summarize progress of project along with teammates in US & Europe. Present reports to upper management regarding project status.

Responsibilities

- Responsible for recent product development or equipment design for medical devices.
- Maintain current working knowledge of the key international standards, regulations and regulatory guidance that govern the medical devices industry, medical electrical equipment.
- Coordinate with Project Lead of Partner company and develop concept designs
- Conduct product design and development in accordance with CE & FDA regulations relating to medical device design and manufacture.
- Understand Customer Requirements, Specifications and accordingly make recommendations/improvements for existing concepts
- Responsible for New Product Design and Development.
- Discuss details, DAP with customer to match their requirements
- Provide support to manufacturing & assembly team to resolve queries.




- Managing overall design operations with a view to ensure strong design with relatively competitive delivery time using effective design and management techniques.
- Leading automation projects from design concept to implementation, have to ensure correct design, accurate manufacturing, successful commissioning and cost control of various automation and SPM projects.
- Create 3D Models, Assemblies, Drawings, Design Documents & Machine Manual.
- Verification of CAD & ERPBill of Material, perform tolerance analysis and ensure design for manufacturability.
- Conceptual Sketch, CAD presentation, Simulations of new project for presenting functionality and application to customer.
- Proficient in Design & development of Coordinate Measuring Machine & Instruments, various Mechanisms for SPM, Jigs & Fixtures for automotive component measurement & holding.

Qualifications

- Experience - 8+ years in Mechanical Design.
- Diploma or Degree in Mechanical Engineering or others
- Willingness to travel, if required
- Strong Communication Skills (Written & Oral)
- Team Player
- Technical Writing
- Experience in client co-ordination
- Experience with basic statistics and/or reliability methodologies.
- Detail oriented, ability to read various standards and guidelines & define implementation details

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Design Engineer (Pune)
🏢 IZiel Healthcare
📍 Pune