Packaging Engineer - Medical Devices

Description

Do you want to part of developing state of the art manufacturing solutions for medical devices, helping patients to get better treatment?

Are you ready to lead cross-functional projects, delivering on time and quality to clients’ satisfaction?

Do you want to cooperate with highly skilled colleagues to bring new products to market in a fast-growing and successful global company?

Then you may be the Packaging Engineer we are looking for in Phillips-Medisize’s Global Innovation & Development Center (Virum or Struer).

As a Packaging Engineer, the main criterion of success is to establish, review and maintain requirements/specifications, risk analyses and procedures needed to ensure safe products and efficient manufacturing processes within packaging and Labeling. You will be an instrumental part in development, design optimization, design transfer, technical support, and life-cycle management related activities for secondary packaging.

What You Will Do In Your Role

• Responsible for the labelling and packaging process from development to commercial production.
• Support of development (design), verification, validation and implementation of packaging designs including serialization.
• Review and approve development documentation on labelling/packaging.
• Clarify technical requirements and specifications for packaging components and concepts.
• Review and approve engineering drawings and tolerance calculations for packaging materials.
• Develop, execute, and report verification methods and testing in cooperation with external partners.
• Participate in technical and design reviews for combination products.
• Responsible for transfers from development to manufacturing – translation of design outputs into production specifications.
• Ensuring labelling setup in SAP MII and printers.
• Coordinate label development internally within the Molex organization.
• Ensure documentation for biocompatibility is available and up to date (REACH, ROHS, California Prop. 65, …).
• Support submission by providing compliant and comprehensive packaging/labelling overview.
• Support update of packaging, labeling, and IFU as part of commercial launch.
• Coordinate packaging development with external partner and costumers.
• Clarify requirements with costumers and coordinate through product launch.
• Write and/or review regulatory documentation for packaging.
• Lead root cause analyses for failures for commercial packaging.
• Collaboration with RA (Regulatory Affairs) and HFE (Human Factor Engineering) ensuring compliance.

The Experience You Will Bring

Requirements:

• University degree in engineering
• Experienced in secondary packaging development, product transfers, product maintenance and manufacturing
• Understanding of applicable manufacturing/testing procedures of secondary packaging of medical devices and manufacturing processes
• Experience within medical device industry and familiar with regulations and standards (e.g., 21 CFR 210/211/820, ISO 14971, ISO 13485, EMA scientific guidelines on the packaging of medicinal products)
• Experience in system and risk management engineering as well as design control, change control and deviation handling
• Knowledge of MS Office, Access and other relevant IT tools or systems
• Ability to work independently, across functional teams and with external partners
• Strong technical understanding and the ability to read, analyze and interpret technical procedures and governmental regulations
• Capability to drive multiple projects in a fast-paced environment
• Strong problem-solving skills
• Fluent in English

What Will Put You Ahead

• Knowledge of SAP (especially MII)

Phillips-Medisize A/S is an expert in the design, development, and delivery of advanced drug delivery devices and connected health solutions. The customers are leading pharmaceutical companies worldwide. Phillips-Medisize A/S is a part of Phillips-Medisize the Pharmaceutical and Medical Division of Molex. The company offers innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch. Read more about Phillips-Medisize A/S at phillipsmedisize.com.

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