Job type: Full-time

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Principal Device Lifecycle Engineer

Position Summary

The Principal Device Lifecycle Engineer resides in the Devices Center of Excellence (COE) as part of Global Technical Operations (TO). This position is based at the Janssen Beerse Manufacturing location in Belgium or at the Janssen Schaffhausen Manufacturing location in Switzreland. Global Technical Operations is a division of the JSC of Johnson & Johnson (J&J). TO is a worldwide organization, working in close partnership with Manufacturing Technical Operations (MTO) and Pharmaceutical Development and Manufacturing Sciences (PDMS) organizations. The primary focus of TO is to provide technical competence and manufacturing excellence to J&J’s pharmaceutical environment and product portfolio as well as to the other sectors (Device / Consumer) when needed.

The principal device lifecycle engineer is responsible for the ongoing lifecycle engineering and technical support for the device constituent for combination products in the Janssen Supply Chain network. The principal engineer transitions the responsibilities from development to manufacturing and takes accountability for technical support including design change control, process improvements, complaint analysis, CAPA and audit support as required. The principal device lifecycle engineer is the key point of contact to site operations and quality leadership for his area of responsibility. The principal device lifecycle engineer ensures that all validation activities and ongoing production conducted at suppliers, external manufacturers and internal manufacturing and assembly facilities 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. The Principal Device Lifecycle Engineer leads and manages product and process quality improvement and reliability projects to stabilize new manufacturing processes as necessary using quality engineering and process excellence (six-sigma) tools.

Principal Responsibilities
  • Device manufacturing process capacity scale-up for internal and external manufacturing, all technical aspects of capacity scale-up to support global demand for the product life-cycle
  • Develop and qualify additional supplier capacity (multi-cavitation 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.
  • Device life-cycle engineering including process engineering, product engineering and support to site or external manufacturing network as necessary.
  • Viewed as a subject matter expert in one or more aspects of the end to end medical device development and supply chain.
  • Support assembly sites in troubleshooting technical issues as necessary, Contribute technical expertise to review post market vigilance data as necessary.
  • Lead projects as necessary to address issues with customer satisfaction, quality, manufacturing improvements and cost reductions, Lead design change controls for devices.
  • Perform technical assessments on combination product change controls and provides audit support where necessary.

Qualifications

KNOWLEDGE SKILL AND ABILITY REQUIREMENTS:
  • Proven ability to responds to complex inquiries from all levels of employees or external sources regarding a variety of questions is required.
  • 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
  • Strong organizational, conflict management and decision-making skills are required.
  • 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.
  • Product design experience is a plus, process design and development experience, Equipment development and implementation. Project management capability and certification
  • 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.

Degree
  • BS in Engineering or Science required, with a preference for Mechanical, Biomedical, or Materials
  • A minimum of 9 years’ experience in some aspects of medical device design, development, new product introduction and/or technical support

Languages
  • Fluent in native language (Flemish) or German with bi-lingual in English, ability to speak, present and/or respond before groups of customers, employees, health authorities/regulatory agencies, clients.

Specific Systems
  • 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.

Physical Requirements/Working Conditions
  • May require up to 25% travel.

Primary Location

Belgium-Antwerp-Beerse-

Other Locations

Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen

Organization

Cilag GmbH International (8525)

Job Function

Engineering

Requisition ID

2206017927W

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Deadline: 05-05-2024

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