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Senior npi engineer (m/f/d)

Aachen
J&J Family of Companies
Ingenieur
Inserat online seit: 24 Februar
Beschreibung

At Johnson & Johnson,u202fwe believe health is everything. Our strength in healthcare innovation empowers us to build au202fworld where complex diseases are prevented, treated, and cured,u202fwhere treatments are smarter and less invasive, andu202fsolutions are personal.u202fThrough 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.u202fLearn more at jnj.com (https://www.jnj.com.). As 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. Job Function: Supply Chain Engineering Job Sub Function: Process Engineering Job Category: Scientific/Technology All Job Posting Locations: Aachen, North Rhine-Westphalia, Germany Job Description: Senior NPI Engineer (Supplier & Process Engineering) (m/f/d) Job Summary The Senior NPI Engineer leads supplier and process engineering activities for new product introductions. This role drives robust industrialization, ensures supplier readiness, and owns process validation and risk management activities. The Senior NPI Engineer influences design decisions, leads crossu2011functional alignment, and ensures flawless design transfer and launch readiness. Key Responsibilities Lead process development and industrialization for internal and external manufacturing processes. Own PFMEA, control plans, validation strategies, capability studies, and documentation. Conduct supplier capability assessments, gap analysis, and readiness reviews. Provide authoritative DFM/DFA/DFX guidance to R&D and program teams. Lead process validations (IQ/OQ/PQ), data analysis, and technical decision-making. Drive PPAP deliverables, supplier qualification, and tooling readiness. Partner with R&D, Regulatory, Operations, and Quality to ensure seamless design transfer. Identify risks, define mitigation actions, and ensure compliance with FDA, ISO 13485, and internal quality systems. Lead structured problem-solving (DMAIC, 8D, root cause analysis) for supplier or process failures. Support cost, yield, and scalability improvements throughout the NPI lifecycle. Represent the function in program leadership meetings and provide readiness updates to management. Qualifications u2013 Required Bacheloru2019s degree in Mechanical, Industrial, Electrical, Biomedical, or related engineering field. 7u201310 years of experience in NPI, Supplier Engineering, Manufacturing Engineering, or Process Engineering. Demonstrated expertise in DFX, PFMEA, process validation, and supplier qualification. Strong experience in regulated environments (medical device strongly preferred). Proven ability to lead cross-functional initiatives and influence technical decisions. Strong data analysis and statistical skills (DOE, MSA, SPC). Qualifications u2013 Preferred Experience with PPAP/APQP and complex supplier ecosystems. Background in microu2011assembly, catheter manufacturing, machining, electronics, or automated processes. Six Sigma Green Belt or Black Belt certification. Experience mentoring junior engineers. Key Competencies Technical authority & decision-making Influence & cross-functional leadership Advanced problem-solving Execution rigor & ownership Risk management & quality compliance Strategic thinking & scalability mindset The anticipated base pay range for this position is 75.000 EUR to 118.450 EUR. Required Skills: Preferred Skills: Agile 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

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