Medical Device Packaging Engineer-1

VMC Soft Technologies, Inc; Karnataka; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

VMC Soft Technologies, Inc. is seeking a Medical Device Packaging Engineer in Bangalore to design, develop, and validate packaging systems for medical devices.

You will lead packaging validation per ISO 11607, manage DHF documentation, and ensure sterile barrier systems meet FDA/ISO standards. The role requires 6–8 years of hands-on experience in packaging design, development, and verification, with strong knowledge of ISTA testing and DFMEA/PFMEA processes.

Qualifications

• Bachelor’s degree in a relevant engineering field with packaging focus.
• Hands-on experience in medical device packaging design and validation.
• Knowledge of ISO 11607 and ISTA testing protocols.
• Familiarity with DFMEA/PFMEA, Design Controls, and DHF documentation.

Responsibilities

• Conceptualize and document packaging systems for medical devices.
• Develop specifications and maintain ISO 13485 compliant DHF.
• Plan and execute packaging validation studies per ISO 11607.
• Perform transit testing and interpret ISTA results for package integrity.
• Collaborate with R&D, Quality, Sterilization, Manufacturing, and suppliers.
• Investigate failures and drive corrective actions in packaging design.
• Ensure regulatory compliance with FDA/ISO/ASTM standards.

Skills

Medical Device Packaging

Packaging Design

Packaging Verification & Validation

ISO 11607-1

ISO 11607-2

ISTA 1

ISTA 2

ISTA 3A

DFMEA/PFMEA

Design Controls

FDA Compliance

Sterile Barrier Systems

Packaging Materials

Vibration Testing

Education

Bachelor's in Packaging Engineering

Bachelor's in Packaging Science

Bachelor's in Mechanical Engineering

Bachelor's in Materials Engineering

Tools

Vibration Table

Drop Tester

Incline Impact Tester

Compression Tester

Job description

Job Title: Medical Device Packaging Engineer

Experience: 6 8 Years

Location: Bangalore, Karnataka

Work Mode: Onsite

Industry: Medical Devices / Healthcare

Employment: Full-Time

Notice Period: Immediate Joiners Preferred Role Overview

We are looking for an experienced Medical Device Packaging Engineer to design, develop, test, and validate packaging systems for medical devices. The ideal candidate will have strong hands-on experience in packaging design, packaging validation, sterile barrier systems, distribution testing, and applicable FDA/ISO standards.

Key Responsibilities

• Conceptualize, develop, and document packaging systems including sterile barrier systems, protective trays, pouches, cartons, and shippers.
• Develop packaging specifications and maintain documentation in accordance with ISO 13485 Design Controls.
• Prepare and maintain Design History File (DHF) documentation, including packaging verification/validation protocols, test reports, and DFMEA/PFMEA.
• Design and execute packaging validation studies in compliance with ISO 11607-1 and ISO 11607-2.
• Plan and perform transit and distribution simulation testing to ensure package integrity throughout transportation and storage.
• Conduct ISTA 1, ISTA 2, and ISTA 3A testing and interpret test results.
• Work with R&D, Quality, Sterilization, Manufacturing, and supplier teams on packaging development.
• Ensure packaging materials are compatible with sterilization methods such as Gamma, E-beam, and Steam.
• Investigate packaging failures, damaged packages, and test failures and perform root cause analysis.
• Develop corrective actions and improve packaging designs based on validation and distribution test results.
• Ensure packaging designs comply with applicable FDA, ISO, ASTM, and industry standards.
• Work with suppliers to identify suitable packaging materials and support cost optimization without compromising product safety or quality.

Required Skills

• Strong experience in Medical Device / Product Packaging Engineering.
• Hands-on experience in Packaging Design, Development, Verification and Validation.
• Strong knowledge of ISO 11607-1 & ISO 11607-2.
• Hands-on experience with ISTA 1, ISTA 2 and ISTA 3A testing.
• Knowledge of ASTM D4169 is preferred.
• Experience with sterile barrier systems and medical device packaging.
• Strong knowledge of packaging materials including:
• Corrugated materials
• Folding cartons
• Thermoformed plastics
• Rigid plastics
• Flexible films
• EPS / EPE / EPP foams
• Sustainable packaging materials
• Familiarity with vibration tables, drop testers, incline impact testers, and compression testing equipment.
• Experience with DFMEA/PFMEA, Design Controls, DHF and validation documentation.
• Knowledge of FDA and international regulatory requirements.
• Strong analytical and problem-solving skills with experience in packaging failure investigation.
• Excellent technical documentation and communication skills.

Education

Bachelor's degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Materials Engineering, or a closely related discipline.

Preferred / Desirable Skills

Medical Device Packaging | Product Packaging | Packaging Design | ISO 11607 | ISO 13485 | ISTA 1/2/3A | ASTM D4169 | Sterile Barrier Systems | Packaging Validation | DFMEA/PFMEA | Design Controls | FDA Compliance

Candidate Preference

Immediate Joiners Are Highly Preferred.

Candidates with a shorter notice period who can join immediately are encouraged to apply.