Mechanical Design Manager Medical Devices - Oragadam - Kanchipuram

we are Hiring for Mechanical Design Manager ( Medical Devices ) Candidates for our Medical devices company in Singadivakkam village Kanchipuram

.We need only candidates from Health Care, Medical Devices and Pharma Sectors

Mechanical Design Manager Medical Devices

Location:

Company Overview

• Global-standard medical device design and manufacturing organization.
  
• Specializes in precision engineering, high-reliability components, and system solutions for healthcare and medical OEMs.
  
• Operates under strict quality, regulatory, and compliance frameworks.
  

Role Summary

• Lead mechanical design activities for medical devices from concept to production release.
  
• Drive CAD development, design controls, risk management, and DFM/DFx.
  
• Ensure full compliance with global medical device regulations and standards.
  

Key Responsibilities

• Lead and mentor a team of mechanical design engineers.
  
• Create 3D models, assemblies, drawings, and BOMs using SolidWorks, UG NX, or Creo.
  
• Manage design control activities: inputs, outputs, reviews, risk analysis, and documentation.
  
• Prepare DHF, DMR, DHR, and technical regulatory documentation.
  
• Ensure compliance with FDA, ISO, and international medical device standards.
  
• Collaborate with manufacturing for tooling, process validation, and design transfer.
  
• Work with suppliers for machining, plastics, metal forming, casting, and fabrication.
  
• Perform GD&T, tolerance stack-ups, and coordinate FEA activities.
  
• Support verification and validation (V&V) planning and execution.
  
• Use PLM/PDM systems for change control, ECO workflows, and release management.
  
• Participate in CAPA, non-conformance investigations, and root-cause analysis.
  

Regulatory & Compliance Requirements

• FDA

  21 CFR Part 820

  (QSR) compliance.
• FDA

  21 CFR Part 11

  (electronic records/signatures).
• Expertise in

  ISO 13485

  ,

  ISO 14971

  ,

  IEC 60601

  , and

  ISO 10993

  .
• Familiarity with

  GMP/cGMP

  practices for regulated manufacturing environments.
• Understanding of

  ISO 14644

  cleanroom classifications.
• Knowledge of sterilization standards:
  
• ISO 11135 (Ethylene Oxide)
  
• ISO 11137 (Radiation)
  
• ISO 17665 (Steam)
  
• Experience preparing compliant documentation for audits and regulatory inspections.
  

Required Qualifications & Skills

• Bachelors or Master’s degree in Mechanical Engineering.
  
• 10–18 years of experience in mechanical design for medical devices or regulated industries.
  
• Expert CAD skills in SolidWorks, UG NX, or Creo.
  
• Strong knowledge of metal forming, machining, plastics moulding, and casting.
  
• Proven experience in DFM, DFMEA, design controls, and manufacturing transfer.
  
• Strong GD&T, tolerance analysis, and engineering calculation capability.
  
• Excellent communication and cross-functional coordination skills.
  

Preferred Skills

• Experience with contract manufacturing or medical device OEMs.
  
• Knowledge of rapid prototyping and test method development.
  
• Exposure to FEA and simulation tools.
  
• Understanding of sterile packaging and cleanroom assembly requirements.
  
• Familiarity with EU MDR and global regulatory submissions.
  

Success Indicators

• Delivering high-quality, compliant designs that pass V&V with minimal rework.
  
• Smooth manufacturing transfer and reduced design cycle times.
  
• Strong audit-ready documentation and regulatory alignment.
  
• Effective leadership and collaboration with cross-functional teams

Interested candidates can call me at

Thanks and Regards

L Sainath Jayaram

SAI HR CONSULTANTS

DIRECTOR TALENT ACQUISITION

8015088704

sainathjayaram95@gmail.com