Sr Eng RD Soft Eng

Biopharma Careers; Boston (MA); On-site; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson in Boston is seeking a Senior Quality Engineer, Product Software Development to lead quality activities on SaMD projects. You will drive software risk assessments, define test strategies, and mentor teams on design controls and defect analysis.

Responsibilities include supporting software development, facilitating risk sessions, coordinating verification, reviews of test results, and ensuring regulatory compliance across IEC 62304, FDA guidance, ISO 13485, and related

Qualifications

• Bachelor's degree required; advanced degree preferred.
• Degrees in Engineering, CS, IS, or Biomedical/Bio-engineering.
• Minimum 4 years in regulated industry quality/new product development/manufacturing.
• ASQ Certification as Software Quality Engineer preferred.

Responsibilities

• Lead design, development and testing of Medical Device Software (SaMD).
• Provide leadership on software development processes and practices.
• Facilitate risk assessments and develop risk documents.

Skills

Quality engineering

Software quality

Project management

Communication

Analytical reasoning

Education

Bachelor's degree in Engineering/CS/IS/biomedical

Advanced degree preferred

Tools

SAP PLM

Job description

Johnson & JohnsonPosted October 16, 2026# Sr Eng RD Soft EngBoston, United States Full timeInformation Technology SeniorNotify me about similar jobsView Full Job & Apply at Johnson & JohnsonJohnson & Johnson is the source of truth for this posting and owns the application process. We surface normalized context and market comparison you won't find on the original listing.## About this opportunityAt 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.comAs 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:**R&D Product Development**Job Sub Function:**R&D Software/Systems Engineering**Job Category:**Scientific/Technology**All Job Posting Locations:**Boston, Massachusetts, United States of America**Job Description:****Job Description**Senior Quality Engineer, Product Software DevelopmentSynthes or DePuy; West Chester, PA or Warsaw, IN or Raynham, MA or Palm Beach Gardens, FL or Rheinsheim, Germany**SECTION 1: JOB SUMMARY\\***The Senior Quality Engineer, Product Software Development, will provide quality leadership on new product project teams responsible for the development of medical device software systems. The Senior Quality Engineer will be the subject matter expert in requirements gathering, facilitating software risk assessments, defining test strategies, and guiding project teams on design controls and defect analysis.**SECTION 2: DUTIES & RESPONSIBILITIES\\***Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position has the following responsibilities:Support the design, development and testing of Medical Device Software, including Software as a Medical Device (SaMD) products.Provide leadership, guidance and expertise on the software development process, procedures and practicesPartner with R&D to refine requirements, and to ensure that architecture/ design documents are comprehensive.Facilitate the documentation and tracking of verification activities, including code review findings.Review test case execution results and manage defects.Facilitate software risk assessment sessions and own the development of risk documents.Support regulatory filings and registrations.Support internal and external audits or inspections of SaMD products and processes and own Non-conformances or CAPAs and drive root cause investigations.Provide technical support for audits of software suppliers and software consultants.Conduct training on Medical Device Software development processes and quality systems.Train and mentor new engineers and lower-level quality engineers.Provide expertise in applicable industry standards and regulations including, but not limited to as IEC 62304, FDA guidance, FDA Part 11, ISO13485, EU MDR, ISO14971, IEC 62366, ISO 27001, and HIPAA.Provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures, as well as medical device regulations.Ensure that patient’s ePHI and PII data is protected and security requirements are met.Know, understand, incorporate and comply with all applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures for Health Care Compliance Program and Code of Conduct.Additionally:o Responsible for communicating business related issues or opportunities to next management levelo Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.o For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicableo Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedureso Performs other duties assigned as needed**SECTION 3: EXPERIENCE AND EDUCATION\\***· A bachelor’s degree or university degree is required. An advanced degree is preferred.· Degrees in Engineering, Computer Science, Information Systems, Biomedical/Bio-engineering Degree preferred.· A minimum of 4 years of regulated industry experience in a quality, new product development, or manufacturing engineering capacity is required.· The ability to apply appropriate Quality tools/systems/processes to meet departmental goals and objectives as required.· Demonstrated ability to prioritize and manage multiple projects while meeting deadlines/budgets is required.· Ability to perform duties in accordance with policies and procedures and to comply with civil rights requirements.**SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS** \\*· Ability to work in a team and demonstrate good interpersonal, organizational, and verbal/written communications skills.· Extensive use of the personal computer and associated work tools (Word, Excel, Power Point) is required.· Medical device industry experience.· ASQ Certification as a Software Quality Engineer, or equivalent, is preferred.**SECTION 6: ADDITIONAL POSITION REQUIREMENTS**This position reports to the Manager or Senior Manager of Quality Engineering · Potential internal interfaces that this role may encounter include:o Interfacing with other Quality Team memberso Working with Research & Development on product issueso Working with Product Owners on product requirementso Working with Program Management on product scheduleso Working with other product teams to support other products or platformso Working with other supporting teams such as Product Security, Regulatory Affairs, Medical Affairs, Medical Safety, Customer Support, Product Complaints, Privacy, Legal, Independent Reviewers, etc. for review and approval of design history file (DHF) documentation**Required Skills:****Preferred Skills:**Agility Jumps, Analytical Reasoning, Coaching, Collaboration, Critical Thinking, Model-Based Systems Engineering (MBSE), Product Design, Report Writing, Requirements Analysis, Research and Development, SAP Product Lifecycle Management, Scripting Languages, Software Architectures, Software Development Management, Software Engineering Practices, Software Quality Assurance (SQA), Systems Development Lifecycle (SDLC), Technologically Savvy**The anticipated base pay range for this position is :**$109,000.00 - $174,800.00Additional Description for Pay Transparency:Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Company’s long-term incentive program.Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:Vacation –120 hours per calendar year