Senior Software Design Quality Engineer

Responsibilities

• Drive quality focused design and development of software within the software development lifecycle (Agile/waterfall/SAFe/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability.
• Use Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) technical expertise, knowledge, and experience to rapidly innovate the company's medical devices for use in chronic heart failure patients.
• Lead and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Software Failure Modes and Effects Analysis (SFMEA) and Risk Management Reports.
• Drive assessments of end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets which include but are not limited to software detailed designs, software architecture and specifications.
• Ensure that Design Controls are compliant with IEC 62304.
• Ensure that FDA and other regulatory knowledge and experience is applied to risk management, software development and testing.
• Participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing feedback on software verification and validation deliverables.
• Develop and/or review test protocols, reports, and engineering summaries
• Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting.
• Review and approve Change Requests as needed to release software revisions to production/field.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
• Drive the success of the Quality System performance measures by completing tasks on time and with a high level of Quality
• Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system as necessary.
• Support 3rd party audits, including follow-up on actions.
• Drive compliance of QMS through authoring and updating Standard Operating Procedures (SOP).

Requirements

• Education:
• A minimum of a Bachelor's degree in an engineering or scientific discipline is required. An advanced degree in a related field is also an asset.
• Experience and Skills
• Required:
• A minimum of 5 years of related work experience within the medical device industry on SaMD and SiMD systems.
• Experience with quality engineering under quality system regulations, including but not limited to 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR.
• Experience with software development lifecycle processes (waterfall, agile, and DevOps) as applied within the regul

Benefits

Additional Information

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 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: Quality Job Sub Function: R&D/Scientific Quality Job Category: Professional All Job Posting Locations: Danvers, Massachusetts, United States of America Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for Senior Software Design Quality Engineer role to be located at Danvers, MA. The Senior Software Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a key role in product risk management, cybersecurity, change controls, test reviews, and design controls. This engineer should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. Be ready to make a significant contribution to a dynamic, fun, multi-disciplinary team, where a self-motivated engineer with excellent written and verbal communication skills stands ready to succeed. Seize the opportunity today to join this collaborative, high performing team within the fastest growing business in MedTech. Come join our Abiomed team today!

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