Mechanical Engineer NPD & Mechanical Simulation (Medical Devices)

Innoiq Engineering; Pune District; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

Innoiq Engineering in Magarpatta, Pune is seeking a Mechanical Engineer for NPD and Mechanical Simulation in medical devices. You will drive product development from concept to release, validate drawings to ASME, and collaborate with cross-functional teams.

Candidates should have 6–8 years in product development, strong skills in SolidWorks CAD, FEA/ANSYS, GD&T, plastic molding, 3D printing, and knowledge of ISO 13485, ISO 14971, and design controls.

Qualifications

• 6-8 years of experience in product development.
• Proficiency in SolidWorks CAD, Siemens Polarion (beneficial)
• Strong knowledge of GD&T and tolerance stack-up analysis
• Expert in plastic injection molding; 3D printing/additive manufacturing
• Experience with FEA and ANSYS Workbench
• Understanding of ISO 13485, ISO 14971, and Design Controls (21 CFR Part 820)
• Good communication skills and ability to work in cross-functional teams
• Good knowledge of AGILE Practices (desired)
• Should be proficient user of MS Office, Outlook etc.

Responsibilities

• Validate and approve components and assembly drawings as per ASME standards and release them in PLM systems.
• Lead product development and sustaining engineering activities.
• Lead preparing Risk Management documents (DFMEA, reports) with the Quality team.
• Ensure compliance with FDA and ISO standards during product development and documentation (DHF).
• Lead design reviews, cost reduction and value engineering initiatives.
• Support engineering change management and documentation in PLM tools.

Skills

SolidWorks CAD

GD&T

FEA/ANSYS

Plastic injection molding

3D printing / Additive manufacturing

ISO 13485

ISO 14971

Design Controls (21 CFR Part 820)

Siemens Polarion

Cross-functional teamwork

AGILE practices

MS Office / Outlook

Education

BE / B.Tech / M.Tech Mechanical Engineering

Tools

Siemens Polarion

Job description

Position: Mechanical Engineer NPD & Mechanical Simulation (Medical Devices)

Department: R&D / Product Development

Experience: 6-8 Years
Qualification: BE / B.Tech / M.Tech Mechanical Engineering
Location: Magarpatta, Pune

Key Responsibilities

• Validate and approve components and assembly drawings as per ASME standards and release them in PLM systems.
• Lead product development and sustaining engineering activities.
• Lead preparing Risk Management documents (DFMEA, reports) with the Quality team.
• Ensure compliance with FDA and ISO standards during product development and documentation (DHF).
• Lead design reviews, cost reduction and value engineering initiatives.
• Support engineering change management and documentation in PLM tools.

Required Skills

• 6-8 years of experience in product development.
• Proficiency in SolidWorks CAD, Siemens Polarion(beneficial)
• Strong knowledge of GD&T and tolerance stack-up analysis.
• Expert in plastic injection molding; 3D printing/additive manufacturing.
• Experience with FEA and ANSYS Workbench.
• Understanding of ISO 13485, ISO 14971, and Design Controls (21 CFR Part 820).
• Good communication skills and ability to work in cross-functional teams.
• Good knowledge of AGILE Practices (desired).
• Should be proficient user of MS Office, Outlook etc.