Medical Product Design and Documentation

GLOINNT Solutions; Bengaluru; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

GLOINNT Solutions in Bengaluru seeks a Mechanical Engineer with 5–7 years of overall experience and 3–5 years in the medical device sector. You will work on CAD-based design, GD&T, and tolerance analyses to support robust product development.

Proficiency in Solid Edge and NX, plus ability to perform calculations and contribute to design control, DHF documentation, and risk management aligned with EU MDR requirements.

Qualifications

• 5 to 7 years of mechanical engineering experience.
• 3 to 5 years in medical device industry.
• Proficient in CAD (Solid Edge & NX) and engineering calculations.
• Proficient in GD&T and tolerance stack-up analysis.
• Ability to generate alternative mechanisms/concepts to reduce technical cost.
• Ability to perform theoretical calculations for concepts.
• Experience in Design Control process and DHF documentation for medical devices.
• Experience in EU MDD to MDR gap analysis and risk management (FMEA, Failure analysis, etc.).

Responsibilities

• Generate alternative mechanisms/concepts to improve cost efficiency.
• Perform theoretical calculations for proposed concepts.
• Report and track product, project, and process metrics using standard methods.
• Contribute to design control documentation and DHF updates.
• Support EU MDR gap analysis and risk management activities.

Skills

Mechanical design

Engineering calculations

GD&T

Concept development

Technical reporting

Tools

Solid Edge

NX

Job description

• Mechanical Engineer with overall experience of 5 to 7 years with 3 to 5 years in medical device industry is mandatory
• Proficient in CAD (Solid Edge & NX) and Engineering calculations
• Proficient in GD&T and Tolerance stack up analysis
• Ability to generate alternative mechanisms/concepts/solutions to problems or processes, with an emphasis on design for technical cost reductions.
• Ability to perform theoretical calculations for the concepts generated
• Uses existing tools and standard methodologies to report and track product, project, and process metrics
• Experience in Design control process and DHF documentation and/or remediation, for medical devices
• Experience in EU MDD to MDR, Gap Analysis, Risk Management and Analysis(FMEA, Failure analysis, etc.), is preferred.