Device Life Cycle Engineer

h3All Job Posting Locations: /h3pBeerse, Antwerp, Belgium, Schaffhausen, Switzerland /ppAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com. /ppAs guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. /ph3Job Function /h3pSupply Chain Engineering /ph3Job Sub Function /h3pProcess Engineering /ph3Job Category /h3pScientific/Technology /ph3All Job Posting Locations /h3pBeerse, Antwerp, Belgium, Schaffhausen, Switzerland /ph3Job Description /h3h3Senior Device Packaging Lifecycle Engineer /h3pThe Senior Device Lifecycle Engineer supports the Device Packaging Value Optimization Team as part of Drug Product MSAT Organization. This position is based at the Schaffhausen, Switzerland or Beerse Manufacturing location in Belgium. /ppMSAT is a supply chain division of the f Johnson Johnson Innovative Medicines (JJ). MSAT is a worldwide organization, working in close partnership with Manufacturing Technical Operations (MTO) and PCD Primary Container and Device Development (RD) organizations. /ppThe primary focus of MSAT is to provide technical competence and manufacturing science technologies to JJ’s pharmaceutical environment and product portfolio. /ppThe senior device lifecycle engineer is responsible for the ongoing lifecycle engineering and technical support for combination products in the JJ Supply Chain network. /ppThe senior 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. /ppThe senior device lifecycle engineer is the technical key point of contact to site operations and quality leadership for his area of responsibility. /ppThe senior 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. /ppThe Senior 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. /ppThe Senior Device Lifecycle Engineer participates in a cross-functional team executing design changes, network and production capacity changes for growing and established combination products. /ph3Principal Responsibilities /h3ulliDevice 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 /liliDevelop 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. /liliDevice life-cycle engineering including process engineering, product engineering and support to site or external manufacturing network as necessary. /liliViewed as a subject matter expert in one or more aspects of the end to end medical device development and supply chain. /liliSupport 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. /liliLead projects as necessary to address issues with customer satisfaction, quality, manufacturing improvements and cost reductions, lead design change controls for devices. /liliPerform technical assessments on combination product change controls and provides audit support where necessary. /liliSupports 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. /li /ulh3Knowledge Skill And Ability Requirements /h3ulliProven ability to respond to a variety and complex inquiries from various levels of the organization or external sources is required. /liliProven ability to perform root cause investigations, technical analysis and author technical documents is required. /liliExcellent organizational and planning skills, strong interpersonal, verbal and written communications skills. Demonstrated strong collaboration with colleagues is required. /liliStrong organizational, conflict management and decision-making skills are required. /liliMust be able to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile, and rapidly changing environment. /liliExperience in plastic and metals materials and processing technologies is preferred /liliKnowledge expertise in applying Combination Products cGMP regulations is required. /liliExperience in communicating across many levels of an organization. Financial analysis, business planning and business case development is preferred /liliProduct 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. /liliAutomated process equipment development, implementation, and operation is preferred. /liliThe 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. /li /ulh3Other Skills, Abilities Or Qualifications /h3ulliCan manage technical and quality discussions to resolve issues /liliManages multiple products and/or cross-functional teams simultaneously. /liliA minimum of 9 years' experience in relevant aspects of medical device design, development, new product introduction, manufacturing and/or technical support /li /ulh3Degree /h3ulliBS in Engineering or Science required, with a preference for Mechanical, Biomedical, or Materials /li /ulh3Languages /h3ulliFluent in native language (Flemish) or German, bi-lingual in English, ability to speak, present and/or respond before groups of customers, employees, health authorities/regulatory agencies, clients. /li /ulh3Specific Systems /h3ulliDemonstrated experience in complying with one or more of the following: FDA CFR part 3, 4, 210, 211, and 820. /liliDemonstrated experience with FDA regulated Design Control, Change Control, CAPA, and Complaint Handling and/or ISO 13485, Medical devices. /liliProven skills with Change Control, CAPA, Complaint Handling, Risk Management Tools, FMEA, FMECA and others. Engineering drawing interpretation capability, process validation experience. /li /ulh3Physical Requirements/Working Conditions /h3pMay require up to 25% travel. /ph3Preferred Skills /h3pAgile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection /ph3The Anticipated Base Pay Range For This Position Is /h3p€72,500.00 - €115,230.00 /ph3Benefits /h3pIn addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location's eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being career growth | Johnson Johnson Careers. /pulliThis is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change. /li /ul #J-18808-Ljbffr