The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting a Senior Reliability Engineer to be located in Irwindale, CA.
The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Acclarent, Biosense Webster, Mentor, SEDASYS® and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Sedation and Reprocessing. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo, which guides our daily decisions and actions. Our relentless commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year.
The Senior Reliability Quality Engineer - is responsible for supporting BWI Systems Engineer for Equipment, Catheters and Software . He/She will support several New product Development Projects and Sustaining activities, provide supporting documentation and work with our internal and external partners to support the Product Development Process. He/She will drive a robust requirements planning, component qualification, software validation, and safety requirements testing. The Senior Reliability Quality Engineer will report to the Principal Engineer for Systems Engineering.
• Coordinate cross functional teams to address development and sustaining issues internally or with suppliers (direct material and external manufacturers).
• Interacts and collaborate with the following teams on a regular basis: External Operations, Sourcing, Partner Development and Engineering, Compliance, Category Teams, and others as required.
• Ensure effective and efficient use of PE tools and Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and statistical process control while performing assessments at our suppliers.
• Utilize technical expertise specific to applicable categories (ex. Electronics, Software, Plastics, API/Bio, Packaging, Chemicals, and Metals)
• Lead Failure Modes assessments, Drive Non-conformances, Support CAPA, Compliance activities and provide Quality plans in support of new and existing products
• Identify improvements to the technical assessment program based on the technical expertise of the processes and technologies being assessed.
• Help Train and mentor more Junior Engineers
• Write procedures, protocols, and test method validations in support of BWI products and processes.
• At a minimum, a BA/BS degree (BS Engineering preferred) or equivalent in a Life Science, Engineering, or Physical Science is required. A minimum of 4 years of experience in technical areas is also required.
• A Certified Quality Engineer /Certified Quality Auditor Certification (ASQ or equivalent) are preferred.
• Experience in the following categories is preferred: Electronics, Software, Plastics, metals and chemicals.
• Experience in assessing electrical schematics, mechanical drawings, software architecture,is required.
• Experience in mentoring/coaching is required.
• Green Belt or Black Belt certification is preferred.
• A strong background in Process Excellence, Six Sigma, Lean methodologies or operational excellence preferred.
• A strong understanding of standards including IEC 62304 and IEC 60601 is required.
• Must have excellent communication skills. Ability to communicate clearly and concisely across all levels of the organization and across Global Supply Chain is required.
• Ability to foster an effective multi-functional, cross region, cross company team environment is required.
• Must be a team player, organized, detail oriented and possess the ability to influence a multi-functional team.
• A successful candidate will demonstrate Integrity & Credo-Based Decision Making.
• Ability to forge strong collaboration and teaming with suppliers and internal stakeholders is required.
• A successful candidate will be results & performance driven.
• A successful candidate will demonstrate an sense of urgency.
This position is located in Irwindale, CA. and may require up to 15% travel, domestic and/or international.
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