Package Engineer

MDR Job Description CH - Packaging Engineer

PROJECT :

A new Medical Devices Regulation (EU MDR) aimed at strengthening the regulatory framework for medical devices was published in the Official Journal of European Union. The new EU MDR is expected to have a major impact on the entire industry, introducing new substantial requirements for Johnson and Johnson as manufacturer of medical devices. J&J has established the EU MDR Program to address and manage the impact of the EU MDR.

The position is based on site in Zuchwil with 2 days / week home office

OVERALL RESPONSIBILITIES:

• The Package Development Engineer provides technical expertise in the areas of design, development, testing and production scale-up of new packaging components and systems. They work with guidance of Senior/Staff Packaging Development leadership.

POSITION DUTIES & RESPONSIBILITIES:

• Ensuring products meet MDR packaging requirements

• Enhances and validates package components and packaging processes.

• Check packaging configurations (Bill of material) and packaging validation documentation (package transit qualification, packaging shelf life) in PLM/ERP systems and verify their correctness)

• Interprets testing results as required for various projects.

• Technical understanding (drawings, processes, packaging specifications and materials, validation standards, etc.)

• Plan, schedule and track project timelines using appropriate tools.

• Responsible to originate/oversee/assist in the creation & release of change orders (COs) for all packaging related change requests through Agile PLM software.

• Technical understanding (drawings, processes, packaging specifications and materials, validation standards, etc.)

• Initiate, route, verify and handle all the administrative paperwork and formalities in coordination with multiple departments stakeholder contacts.

• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.

• Additional duties as assigned.

PROFESSIONAL EXPERIENCE REQUIREMENTS:

2 years work experience in an adequate position and regulated industry preferred

Experience in packaging, medical device or other regulated industry preferred.

Knowledge of packaging material characteristics and validation practices is required

Knowledge of ISO13485, ISO11607, ISTA and ASTM is preferred

Previous Experience in the areas of Design for Manufacturing or Assembly

Statistical Analysis knowledge preferred (Six Sigma)

Experience working and communicating with internal and external partners, including vendors and suppliers of direct materials and services

Technical writing skills required to include protocols, engineering studies, procedures, project status & special reports

Experience in quality engineering activities such as FMEA, CAPA, and NC preferred

Knowledge of In Process Control preferred

EDUCATIONAL REQUIREMENTS:

Bachelor's Degree in Engineering or equivalent Technical Degree or extensive relevant experience required.

OTHER REQUIREMENTS:

Strong knowledge and skills in MS Office

Knowledge and skills in PLM system, ex. Windchill, Agile, Adaptive, SAP will enhance candidacy

Must be highly organized, creative, articulate and analytical

Strong interpersonal and diplomatic skills

Ability to multi-task independently with minimal supervision

NON-TECHNICAL REQUIREMENTS:

Some flexibility in working hours is required - Must be able to work on multiple simultaneous tasks with limited supervision; - Quick learner, motivated self-starter; - Excellent customer service, interpersonal, communication and team collaboration skills; - Able to follow change management for internal guidelines. - Self-motivation for repetitive work. - Language proficiencies: -English spoken and written; German is a plus.

Thank you very much and we look forward to receiving your application.

Inclusion & Diversity

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!