Senior Software Quality Engineer
Location:
Raynham , Massachusetts
Posted:
January 10, 2017
Reference:
4851160829-en-us

DePuy Synthes Companies of Johnson & Johnson is seeking a Senior Software Quality Engineer located in Raynham, MA.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
Codman Neuro is the Neurological business focused on neurosurgery, neurovascular and neuromodulation, offering a broad portfolio of solutions including programmable shunt systems, catheters, trauma monitoring devices, drug pumps, neurovascular coils, liquid embolics and vascular reconstruction devices

The Senior Quality Engineer will be responsible Codman Neuro NPD projects of varying scope and complexity.  The Sr. Quality Engineer will be responsible for the software aspects of a project, interacting with external design and development partners, participating on cross-functional project team through all phases of the product development process, and assisting the technical team with planning, executing, documenting and communicating testing activities. The Sr. Quality Engineer may also be responsible for the electrical and hardware aspects of a project.
Lead and/or support the design and development of software requirements and electrical/software architectures for medical devices in close collaboration with R&D.
Lead and/or support risk analysis activities (FMEAs and SHAs).
Lead and/or support software validation, embedded and tools.
Support external partners in the development of product software based on software requirements.
Coordinate, review and approve software documentation created by external partners, including product requirements, schematics, code, verification and validation test strategy, protocols and reports.
Support Design Reviews, Technical Reviews, and Peer Reviews
Fulfill design control requirements compliant: software specifications, detailed design files, design verification and validation test plans, risk management, DHF,  protocols, and reports in accordance with company procedures, FDA and ISO guidelines
Collaborate with internal and external partners to launch new products.
Participate to internal and external audits.
Maintain the Quality System.

Qualifications
A minimum of a Bachelor's degree is required; a degree concentration in Electrical or Computer Engineering is an asset.
A minimum of 4 years of experience in a software quality assurance role is required. Experience with ISO 13485, ISO 14971, ISO 80002, IEC 62304, and FDA GMPs is preferred. Experience in the medical device industry or other regulated industry is preferred.
Experience in medical device (With the emphasis in hand held units, monitoring devices and/or neurosurgery field) product development including Design Verification & Validation is preferred.
Experience with Electrical safety testing is required (i.e., 60601-1) is required.
Experience with Software development life cycle is required (i.e., 62304) is required.
Medical Software development experience is preferred 
Demonstrated detailed design analysis, statistical analysis and mathematical analysis for a robust and manufactural device is preferred
Must be able to review test methods and test plans for new or updated software projects to determine if the software will perform accurately and reliably under both normal and abnormal conditions.
Must have a thorough understanding of verification and validation processes, including early software defect detection and removal, inspection, and testing methods (e.g., types, levels, strategies, tools and documentation). 
Must be able to review product design documentation to ensure that requirements stated are correct, unambiguous, and verifiable.  Previous NPD/NPI (New product Development/ Introduction) experience is required. Experience with product development to evaluate system interfaces, operational requirements, and performance requirements of overall system preferred.
Must be able to review test methods and test plans for new or updated software projects to determine if the software will perform accurately and reliably under both normal and abnormal conditions.
Experience with programming Rockwell Automation, FANUC robots and LabView preferred. 
Experience with software audits including audit planning, approaches, types, analyses, reporting results and follow-up is preferred. 
Demonstrated leadership abilities are required.
Strong analytical skills are a must.
This position will be located in Raynham, MA and will have up to 10% travel both domestic and international. 

BE VITAL in your career, Be seen for the talent you bring to your work.  Explore opportunities within the Johnson & Johnson Family of Companies.

J2W: LI NA

Primary Location
United States-Massachusetts-Raynham
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Validation

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