Sustenance Design Engineer

Glauben Technologies; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Glauben Technologies in Bengaluru, India, seeks an experienced project professional to lead complex medical device programs from initiation to release, ensuring on-time delivery and quality. You will coordinate cross-functional teams, manage change control and ECO/ECO processes, and ensure compliance with ISO 13485, FDA and EU MDR requirements, leveraging PLM tools such as Windchill and Agile PLM.

This role demands strong communication, documentation discipline, and the ability to navigate

Qualifications

• Experience in project execution and project management.
• Experience managing change management programs.
• Experience creating and managing engineering change orders for releasing records.
• Good knowledge of End of Life or obsolescence processes.
• Experience with PLM tools such as Windchill and Agile PLM.
• Ability to coordinate with cross-functional teams.
• Knowledge of medical device standards like ISO 13485, FDA and EU MDR regulations.
• Excellent verbal and written communication skills.
• Bachelor's degree in Mechanical Engineering or equivalent.

Skills

Project management

Change management

Engineering Change Orders

PLM tools

ISO 13485 knowledge

FDA/EU MDR regulations

Cross-functional coordination

Communication skills

Education

Bachelor's degree in Mechanical Engineering

Tools

Windchill

Agile PLM

Job description

• Experienced in Project Execution and Project Management.
• Should be experienced managing Change Management Programs.
• Should be experienced in creating and Managing Engineering Change Orders for releasing records.
• Good to have kowledge on End of Life or Obsolescence process.
• Should be experienced working on PLM tools (Agile, windchill etc.).
• Ability to co-ordinate and work with different corss-functional teams,
• Good understanding of Medical device standards like ISO 13485, FDA and EU / MDR Regulations
• Excellent verbal and written communication skills.
• Preferred Bachelors Degree in Mechanical Engineering or any other equivalent degree