- Senior Technical member for commercialized System Design Changes and refurb engineering support.
- Work on part obsolescence, supplier change, raw material changes and ensure no line stops.
- Prepare project plans and execute within the cost and quality goals.
- Identify and manage product risks and mitigations.
- Handle the field complaints and manage escalations as per procedure (CAPA etc).
- Ensure adherence to regulations & quality procedures and represent the product in different audits.
- Work floor layout design for utilization of space, process equipment s capacity, minimum material, and people movement, in compliance with EHS regulations and facilitate import/export of required spare parts.
Experience: -
- High level experience in Hardware system design (medical device only), qualification and verification.
- Able to create 3D models and 2D drawings of system components in NX or similar CAD/CAM software.
- Able to assess the Risk, Usability, Safety and Electromagnetic Compatibility (EMC) of any change requirements.
- Develop test protocols and perform prototype testing.
- Design and produce fixtures for machining (sheet, metal, plastic etc) and assembly.
- High level experience in customer complaint troubleshooting and analysis.
- Good knowledge in engineering change request management and experience with different PLM tools (Teamcenter, SAP etc).
- High level experience in Product Life cycle management and awareness on FDA and EU regulations.
- Cross-functional collaboration proven experience with Vendors, Manufacturing, Sales & Marketing, Service, Quality and Regulations is a must.
- Experience in technical leadership of system design team and their requirements.
Qualification: -
Engineering or higher degree in Mechanical/ Electrical / Electronics etc.
Minimum 7 years of experience in Product Design and Development
Performed Technical Lead responsibilities.
