DEVICE LIFE CYCLE ENGINEER

The Principal Device Lifecycle Engineer supports the Device &Primary Container Value Optimization Team as part of Drug Product MSAT Organization.
This position is based at the Schaffhausen, Switzerland or Beerse Manufacturing location in Belgium.
MSAT is a supply chain division of the f Johnson & Johnson Inovative Medicines (J&J).
MSAT is a worldwide organization, working in close partnership with Manufacturing Technical Operations (MTO) and PCD Primary Container and Device Development (R&D) organizations.
The primary focus of MSAT is to provide technical competence and manufacturing science & technologies to J&J’s pharmaceutical environment and product portfolio.
The principal device lifecycle engineer is responsible for the ongoing lifecycle engineering and technical support for combination products in the J&J 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, tech transfers, complaint analysis, CAPA and audit support as required.
The principal device lifecycle engineer is the technical 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 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.
The Principal Device Lifecycle Engineer participates in a cross-functional team executing design changes, network and production capacity changes for growing and established combination products.
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, advise on CAPAs and/or mitigations.
• 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.
• Support for continuous improvement initiatives within the Value Optimization Team relative to policies, procedures, and regulatory compliance.
Informs technical community and responds to changing industry standards, guidelines and trends.
Qualifications KNOWLEDGE SKILL AND ABILITY REQUIREMENTS.
• Proven ability to respond to a variety and complex inquiries from various levels of the organization or external sources is required.
• Proven ability to perform root cause investigations, technical analysis and author technical documents is required.
• Excellent organizational and planning skills, strong interpersonal, verbal and written communications skills.
Demonstrated strong collaboration with colleagues is required.
• 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.
• Experience in plastic and metals materials and processing technologies is preferred • Knowledge & expertise in applying Combination Products & cGMP regulations is required.
• Experience in communicating across many levels of an organization.
Financial analysis, business planning and business case development is preferred • Product and/or process design and development experience is preferred.
Experience in establishing design inputs, planning and executing design verification, design validation (Human Factors) testing is highly preferred.
• Automated process equipment development, implementation, and operation is preferred.
• The ability to use statistical techniques when analyzing data and make rational and logical decision based on that analysis.
Six-Sigma, project management, or recognized root-cause analysis certification is a plus.
OTHER SKILLS, ABILITIES OR QUALIFICATIONS.
• Can manage technical and quality discussions to resolve issues • Manages multiple products and/or cross-functional teams simultaneously • A minimum of 9 years’ experience in relevant aspects of medical device design, development, new product introduction, manufacturing and/or technical support DEGREE.
• BS in Engineering or Science required, with a preference for Mechanical, Biomedical, or Materials LANGUAGES.
• Fluent in native language German or Flemish, 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 , and 820.
• Demonstrated experience with FDA regulated Design Control, Change Control, CAPA, and Complaint Handling and/or ISO , Medical devices.
• Proven skills with Change Control, CAPA, Complaint Handling, Risk Management Tools, FMEA, FMECA and others.
Engineering drawing interpretation capability, process validation experience.