Staff Device Lifecycle Engineer.

Job content

Caring for the world, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science - bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. J&J has more than 250 companies located in 60 countries around the world.

Are you passionate about crafting a world without disease? Do you have expertise in Health Economics and Market Access? At the Janssen Pharmaceutical Companies of Johnson & Johnson, we use heart, science and creativity to discover groundbreaking medicines. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease encourages us. We bring together the best minds and pursue the most promising science.

Janssen Supply Group, L.L.C.is recruiting for a Staff Device Lifecycle Engineer, in Schaffhausen

(Permanent)

Overview

The Engineer will be accountable to work in a multi-functional setting collaborating in device development, technical transfer and manufacturing lifecycle support. The Engineer is responsible for the ongoing lifecycle engineering and technical support for the device constituent and processes of combination products in the Janssen Supply Chain network. The Engineer will transition the responsibilities from development to manufacturing and take accountability for the lifecycle of devices for design control, process, quality and cost improvements, complaint analysis, CAPA and audit support as required. They will be the key point of contact to site operations and quality leadership for their area of responsibility.The Staff Device Lifecycle Engineer will ensure that all device lifecycle activities are in compliance with all applicable procedures and to the requirements of 21 CFR Parts 3, 4,11, 210, 211 and 820 and Johnson & Johnson Policy Standards related to Good Manufacturing Practice (cGMP) for Combination Products, Pharmaceuticals, and Medical Devices.

Responsibilities Include

The Staff Device Engineer will lead, handle and support product and process quality improvement and reliability projects for combination product operations across the globe.

• Support Lifecycle Engineering for Device manufacturing to ensure technical and quality aspects are delivered for Janssen combination products per quality systems requirements.
• Device life-cycle engineering including process engineering, product engineering and support to site or external manufacturing network as necessary.
• Viewed as an authority in aspects of the end to end medical device development, production and supply chain.
• Train and mentor resources in the supply chain to improve overall knowledge and enhance capabilities for technical support of devices and combination products.
• Lead and/or provide technical expertise to projects vital to address issues with customer satisfaction, quality, manufacturing or assembly improvements and cost reductions.
• Support manufacturing sites in solving problems and technical issues.
• Lead design change controls for devices, perform technical assessments on combination product change controls and translate requirements into device design control activities.
• Develop manufacturing operations and process for device production to ensure a robust and reliable delivery of the combination product.
• Ability to write, comprehend, analyze and/or interpret instructions, drawings/specifications, business, professional, scientific documentation, journals or SOP’s.
  
  

Qualifications

• BS in Engineering or Science required, with a preference for Mechanical, Biomedical, or Materials
• A minimum of 5 years’ experience in some aspects of medical device design, development, new product introduction and/or technical support is required
• Demonstrated experience in aligning with one or more of the following is required: FDA CFR part 3, 4, 210, 211, and 820, ISO 13485 and European Medical Device Regulations
• Knowledge & expertise in applying Combination Products cGMP regulations is preferred
• Proven experience with FDA regulated Design Control, Change Control, CAPA, Complaint Handling, FMEA and Risk Management Tools is required
• Intermediate to advanced computer skills, including document management systems, word processing, spreadsheets and basic database applications is preferred
• Operations and Device Manufacturing support, equipment design and/or process development is preferred.
• Proficient in spoken and written English is required. Ability to speak a 2nd language is a plus.
• Ability to write routine business reports and correspondence or procedure manuals using original, prescribed, or innovative techniques or styles.
• The job may require lifting up to 30 lbs. occasionally.
• Must possess valid passport; international travel may be required.
• Travel: 20-30% - project dependent
  
  

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

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

If you want to be a change agent in a challenging environment and shape the future quality organization, please send us your online application (CV, Motivation Letter, Working References etc.).

Primary Location

Switzerland-Schaffhausen-Schaffhausen-

Organization

Cilag AG (8562)

Job Function

Engineering

Requisition ID

2105964576W