Packaging and Labelling Engineer

BACTIGUARD ( SOUTH EAST ASIA) SDN. BHD.; Simpang Ampat; Vor Ort; MYR 60.000 - 90.000; Vollzeit

Zusammenfassung

Bactiguard (South East Asia) Sdn. Bhd. designs and develops primary, secondary, and tertiary packaging for wound care products, focusing on protection, sterility, and sustainability.

The role covers MDR/FDA compliance, ISO 11607 packaging validations, and development of packaging that ensures product stability. The successful candidate will lead packaging projects, collaborate across functions, and ensure labeling, IFU creation, and documentation align with global standards including UDI and

Qualifikationen

• Bachelor's degree in a related engineering/science field; graduate or advanced degree preferred.
• Experience in packaging, labeling or IFU.
• Familiarity with UDI requirements and GS1/HIBC-128 standards.

Aufgaben

• Design and develop primary, secondary, and tertiary packaging for wound care products.
• Select packaging materials considering protection, sterility, barrier properties, shelf life, transport and sustainability.
• Lead packaging projects for new product launches with packaging design and equipment that protect and stabilize products.
• Oversee packaging validations per ISO 11607 and MDR/FDA requirements.
• Manage packaging issues in manufacturing and field; support labeling, CAPAs, audits, and SCARs.

Kenntnisse

Packaging design

Regulatory compliance

Cross-functional collaboration

Project leadership

Labeling

Ausbildung

Bachelor's in engineering/science

Tools

BarTender

CANEA

Adobe Creative Suite

TOPS Pro

ArtiosCAD

Jobbeschreibung

Design and develop primary, secondary, and tertiary packaging for wound care products. This role involves selecting packaging materials in consideration of product protection, sterility, barrier properties, shelf life, transportation and sustainability, and leading packaging projects related to new product development launches.

Key responsibilities

Design and develop primary, secondary, and tertiary packaging for wound care products

Select packaging materials in consideration of product protection, sterility, barrier properties, shelf life, transportation and sustainability

Fulfill MDR and FDA requirements regarding Performance Testing of Shipping Containers and Systems in Compliance to ASTM D4169 or ISTA (510k registration) as required

Review and oversee packaging validations in compliance to ISO 11607 (Packaging for terminally sterilized Medical Device)

Lead packaging projects related to new product development launches by developing packaging design and equipment/machine that provides products protection and stability

Lead troubleshooting in the resolution of packaging related issues in manufacturing and in the field

Provide support to manufacturing issues related to packaging, labelling, IFU's, CAPA's, NC's, audits and SCAR

Interface with external labs (local or overseas) to initiate packaging related testing plans

Create, review and update packaging related to SOP's, drawings, BOM's, technical documentation or Work Instruction (WI)

Develop and maintain labels, IFU's, carton, artwork and ensure compliance with EU MDR, FDA, UDI, GS1, and HIBC-128 requirements

About you

Bachelor's degree in a related engineering/science field; graduate or advanced degree strongly preferred

Experience in packaging, labelling or IFU

Familiarity with Unique Device Identification (UDI) requirements and global barcode standards such as GS1 and HIBC-128

Proficient in BarTender, CANEA, Adobe Creative Suite (Illustrator, Indesign, Acrobat)

Proficient in Packaging design software like TOPS Pro or ArtiosCAD

Dynamic team player and leader that can work effectively and proactively collaborate on cross-functional teams

Experience in Medical device product development including innovation and project/program management, design concept, risk analysis, problem solving skills and technical leadership

Strong communication and presentation skills to lead or facilitate effective discussions and relay technical and/or project information to key stakeholders

Familiarity with ISO 13485, MDR, FDA 21 CFR Part 820 Design Control, ISO 14971, GMP and other standards as they relate to the development and manufacture of medical devices

Strong organizational and time management skills to meet deadlines while managing multiple projects

Bactiguard (South East Asia) Sdn. Bhd. is a Swedish medical device company with a mission to save lives. To achieve this mission, we develop and supply infection prevention solutions which reduce the risk of healthcare associated infections and the use of antibiotics. In this way, we save significant costs for healthcare and the society at large.

Join us and be part of a company that innovates and provides patented technological solutions across the healthcare industry. We are a growing company, established in providing medical device solutions with a Mission to Save Lives, from hospitals, pharmacies, clinics, and patients.

Bactiguard (South East Asia) Sdn. Bhd. is a Swedish medical device company with a mission to save lives. To achieve this mission, we develop and supply infection prevention solutions which reduce the risk of healthcare associated infections and the use of antibiotics. In this way, we save significant costs for healthcare and the society at large.

Join us and be part of a company that innovates and provides patented technological solutions across the healthcare industry. We are a growing company, established in providing medical device solutions with a Mission to Save Lives, from hospitals, pharmacies, clinics, and patients.