Medical Device Packaging Engineer

EXP:6-8

Location:Bangalore

Role Descriptions: Key ResponsibilitiesMedical Device Packaging EngineerPackaging Design & Design Controls:oConceptualize| develop| and document packaging system specifications (sterile barrier systems| protective trays| pouches| cartons| and shippers) under strict ISO 13485 Design Controls. oAuthor technical design history file (DHF) documentation| including Packaging Design Verification/Validation Protocols| Test Reports| and DFMEA/PFMEAs. oCoordinate with Sterilization and R&D teams to ensure packaging materials are compatible with sterilization methods (Gamma| E-beam| or Steam).Testing & Quality Assurance:oDesign| execute| and oversee packaging validation studies compliant with ISO 11607-1 & -2 for terminally sterilized medical devices.oManage and execute transit simulation protocols to ensure sterile barrier integrity post-transport:ISTA 1 Series: Executing basic non-simulation package integrity tests (fixed-displacement vibration and drop testing) to measure fundamental structural durability.ISTA 2 Series: Conducting partial simulation testing combining atmospheric/climatic conditioning with dynamic mechanical stress.ISTA 3A: Performing full parcel shipment simulation testing (small/standard parcel delivery networks such as FedEx| UPS| or direct-to-hospital courier networks).Quality & Problem Solving:oInvestigate test failures or damaged packages to fix design flaws.oFollow FDA and ISO standards to keep packaging compliant for audits.oWork with suppliers to source packaging materials and lower costs without sacrificing safety.

Essential Skills: Packaging Engineer Job DescriptionRole SummaryWe are looking for a Medical Device Packaging Engineer to design| test| and validate safe| sterile packaging for our healthcare products. You will build and test package designs that keep our devices safe and sterile through shipping and storage| ensuring we meet all FDA and international standards.QualificationsExperienceEducational Background: Bachelors Degree in Packaging Engineering| Packaging Science| Mechanical Engineering| Materials Engineering| or a closely related discipline.Work Experience: 3 to 6 years of direct experience in packaging design| development| and validation within manufacturing| consumer packaged goods (CPG)| electronics| or e-commerce.Track Record: Hands-on history of designing primary| secondary| and tertiary packaging that successfully passed standardized distribution testing protocols.Technical SkillsStandards & Compliance:oProven expertise executing ISTA 1 (basic integrity)| ISTA 2 (partial simulation)| and ISTA 3A (parcel shipment simulation) test procedures. oFamiliarity with additional packaging industry standards (ASTM D4169| ISO 11607| or TAPPI) is a strong plus.Material Knowledge: In-depth understanding of corrugated mediums| folding cartons| thermoformed plastics| rigid plastics| flexible films| protective foams (EPS| EPE| EPP)| and sustainable alternatives.Testing Equipment: Familiarity with vibration tables| drop testers| incline impact testers| and compression equipment.Additional RequirementsProblem-Solving: Ability to quickly find the root cause of packaging failures and design reliable solutions.Teamwork & Writing: Clear communication skills for writing test protocols and working with R&D| Quality| and suppliers.

Keyword

Desirable Skills:

Skills: EIS : Production Engineering~Product Packaging

Experience Required: 6-8
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