STAFF SOFTWARE QUALITY ENGINEER Job in Irwindale, California US


Biosense Webster, Inc., a member of Johnson Johnson's Family of Companies, is recruiting for a Staff Software Quality Engineer, located in Irwindale, CA.

Biosense Webster, Inc., is recognized worldwide as an industry leader in cardiac arrhythmia diagnostics and therapy. Guided by the needs of electrophysiologists and cardiologists, the company has pioneered innovative technological advancements ranging from the first deflectable tip catheter to today's most sophisticated three-dimensional cardiac mapping and navigation systems. Biosense Webster, Inc., combines leading-edge technology with a tradition of quality and responsiveness while partnering with the physician to optimize patient outcomes.

The Staff Software Quality Engineer will participate in New Product Development (NPD) teams, Quality System software development teams, manufacturing automated equipment projects, and other activities to develop software products, verification and validation tests (IQ/OQ/PQ), and quality processes to ensure compliance with company Quality System policies, procedures, standards (FDA, ISO 13485, CMDCAS, PMDA) and other worldwide regulatory agencies, and applicable standards as pertains to medical devices. Provide software quality expertise and guidance. Lead and/or support the development, and verification and validation of computer and hardware system software. Support product quality investigations as pertains to software. Will be considered a subject matter expert (SME) on all quality tools and will work on complex problems and projects. Will show leadership in driving program/projects and be resourceful and creative in developing approaches and solutions to problems. Shares technical expertise with others and develop junior level associates.

The Staff Software Quality Engineer will work with other functional groups in support of software development projects, and defining the software quality and compliance standards for new products and processes. Develops and establish effective quality control and associated risk management plans for software projects. The Staff Software Quality Engineer will write, review and/or approve validation protocols and reports for software products, Quality System software, and software driven equipment. They will write, review and/or approve engineering change orders relating to software as well as review and comment on software project plans, test plans, etc. to ensure they satisfy applicable requirements. This individual will use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE). The Staff Software Quality Engineer will direct Failure Mode and Effects Analysis and/or Fault Tree Analysis activities for software projects and ensure that development activities follow design control requirements, software systems and software products are tested per applicable standards, European Essential Requirements are met per the MDD, and product is properly transferred to manufacturing. This individual will participate in MRB review of nonconforming software products; recommend disposition and corrective action. The Staff Software Quality Engineer will initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate and lead and/or perform audits of internal software development projects and evaluate software development and installation activities of external providers. This individual will also assist in complaint analysis as appropriate.

The Staff Software Quality Engineer will assist Regulatory Affairs in developing submissions for new devices as necessary as well as participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes. This individual will make decisions independently on engineering problems and methods, and represent the organization in conferences to resolve important questions and to plan and coordinate work. The Staff Software Quality Engineer will represent Quality Engineering function during regulatory inspections and recommend issue resolution to senior management for significant capability and compliance issues. This individual works closely with functional leadership in planning and executing project milestones in addition to plan, develop, coordinate, and direct one or more large important engineering project or a number of small projects with many complex features. The incumbent will carry out complex or novel assignments requiring the development of new or improved techniques or procedures and work to develop new or improved standard operating procedures and work instructions. The Staff Software Quality Engineer will participate in revision/improvement of procedures and templates governing the Software Development Life Cycle (SDLC). This individual will also assess the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by testing is advisable. Performs other duties assigned as needed.

Qualifications

A minimum of a Bachelor's degree in Computer Science, Computer or Software Engineering, Electrical Engineering or a related engineering discipline along with a minimum of 6 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required. An MBA, Master's, or advanced degree in an applicable field of study along with a minimum of 5 years of related experience, is preferred. An American Society for Quality (ASQ) certification (CQE, SQA, etc) is an asset. Experience or knowledge of Six Sigma, Lean Manufacturing, or Process Excellence tools is desirable. This candidate must have the ability to define problems, collect and analyze data, establish facts and draw conclusions and recommendations. Must have the ability to use broad knowledge of regulatory, technical, and business requirements to conduct due diligence assessments. Project management experience or skills ensuring fulfillment of development requirements is required. Development and implementation of Quality standards applicable to the medical device or other highly regulated industry required. Knowledge of Quality and Operations systems and processes, including GMP, in a regulated industry is required. Knowledge of Quality Systems Regulations (QSR) requirements as they relate to medical devices is required.

Auditing experience is a plus. Knowledge of Quality Engineering, design control, and verification and validation (VV) tools and methodologies required. The ability to effectively communicate with internal and external personnel at all levels of the organization is needed. Well-developed influencing and negotiation skills and the ability to effectively train and mentor a diverse array of employees at all levels of the organization is required. Business and financial acumen is an asset. It is required to possess a clear understanding of theoretical and practical fundamentals and experimental engineering techniques. It is required to be proficient in MS Office (Word, Excel, PowerPoint, and Outlook). Ability to multi-task and manage multiple assignments in a timely manner is required. Excellent verbal and written communication skills are required. It is required to have strong interpersonal and leadership skills as well as good presentation skills. Strong analytical skills are a plus.

This position is located in Irwindale, CA and may require up to 10-15% domestic and international travel.

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