The Staff Manufacturing Development Engineer will partner with the Primary Container & Device, New Product Introduction, and Value Chain Management teams, as well as external partners to develop and implement robust manufacturing process design solutions for Device and Packaging to meet the emerging and future needs of the portfolio. This role will be responsible for the technical development and manufacturing readiness and implementation of new Device and Packaging platforms into the Janssen manufacturing network.
In this role, you will demonstrate your experience in manufacturing development and technical support, and advanced knowledge in the application of engineering principles, world-class manufacturing techniques, and statistical analysis. You will also demonstrate your judgment to
independently plan, coordinate, direct, and complete manufacturing development programs of significant scope and complexity.
The Staff Device Manufacturing Development Engineer is responsible for functioning as an integral member of the device development process in designing, developing, validating and transferring medical devices used in drug/ device combination products. S/he may also lead
projects of some complexity to support the global device platform ensuring adequate capacity and capability for supply of medical devices used in drug/device combo products.
This individual will have demonstrated experience in manufacturing development and technical support with advanced knowledge in the application of engineering principles, world‐class manufacturing techniques, statistical analysis and judgment to independently plan, organize,
direct and complete development and technical support programs of significant scope and complexity.
The incumbent will also be recognized as a subject matter expert in one or more component manufacturing process or assembly technologies for medical device manufacturing.
• Lead device assembly design transfer and packaging technology transfer, including process and equipment qualification (IQ/OQ/PQ), validation, and commissioning activities.
• Lead development of manufacturing strategy, equipment User Requirements and process Failure Mode and Effects Analysis (pFMEA)
• Lead process design and characterization studies
• Contribute to supplier selection process by providing technical leadership and assessments
• Partner with receiving sites to ensure voice of manufacturing is represented in product design (e.g., design for manufacturability)
• Partner with external suppliers to ensure component development processes lead to robust manufacturing processes
• Develop, design, implement, and validate assembly equipment, packaging equipment, jigs, fixtures and gauges
• Provide technical expertise to site personnel to adequately transfer the device and/or packaging technology for design and technology transfer activities
• Develop manufacturing process capacity scale-up for internal and external manufacturing
• Execute processes per quality system requirements to deliver vital design output and device master record documentation for the development process
• Lead technical aspects of capacity scale‐up to support global demand for the product life‐cycle.
• Develop and qualify additional supplier capacity (multi‐cavitations for plastic molded components, other process technologies as necessary) per quality systems requirements.
• Develop and qualify additional capacity for sub‐assembly and assembly processes per manufacturing network strategies for the production of devices.
• Execute Changes according to the change control procedure, act as change owner, assessor or action item owner
KNOWLEDGE SKILL AND ABILITY REQUIREMENTS:
• The ability to interpret engineering drawings is required.
• Financial analysis and business case development is also required for this position.
• Organizational and planning skills will also be required for this role.
• process design and development or equipment development and implementation.
• Experience with process validation and statistical process control.
• Product design experience are preferred.
• Design for manufacturability and assembly experience is required.
• Position requires project management skills, as well as interpersonal communication skills.
• Candidates are also required to possess experience with quality systems and regulatory requirements.
• Proven ability to perform root cause investigations and write technical documents is required.
• Excellent organizational and planning skills, strong interpersonal, verbal and written communications skills. Demonstrates strong collaboration with colleagues
• Must be able to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile, and rapidly changing environment.
• Plastic and metals materials and processing technologies is preferred, Knowledge & expertise in applying Combination Products cGMP regulations is preferred.
• Experience in communicating across many levels of an organization is preferred. Financial analysis, business planning and business case development.
• The ability to use statistical techniques when analyzing data and make rational and logical decision based on that analysis. Six-Sigma certification is a plus.
OTHER SKILLS, ABILITIES OR QUALIFICATIONS
• Can manage technical and quality discussions to resolve issues, • Manages multiple products and/or teams simultaneously.
• Six Sigma Black Belt Certification preferred
• BS in Engineering or Science required, with a preference for Mechanical, Biomedical, or Materials.
• A minimum of 6 years’ experience in some aspects of medical device design, development, new product introduction and/or technical support
• Fluent in native language in German (or in Flemish) with bi-lingual in English, ability to speak, present and/or respond before groups of customers, employees, health authorities/regulatory agencies, clients.
• Demonstrated experience in complying with one or more of the following: FDA CFR part 3, 4, 210, 211, and 820.
• Demonstrated experience with FDA regulated Design Control, Change Control, CAPA, and Complaint Handling and/or ISO 13485, Medical devices.
• Proven skills with Change Control, CAPA, Complaint Handling, Risk Management Tools, FMEA, FMECA and others. Engineering drawing interpretation capability, process validation experience. May require up to 25% travel.