Sr Eng RD Soft Eng

Johnson & Johnson • Boston, MA

1d

About The Position

The Senior Quality Engineer, Product Software Development, provides quality leadership to new product project teams developing medical device software systems, including Software as a Medical Device (SaMD). The role serves as a subject matter expert in requirements gathering, software risk assessments, test strategies, design controls, and defect analysis. It supports software design, development, testing, regulatory submissions, audits, and compliance with applicable medical-device regulations and standards.

The position works with Research and Development, product owners, program management, other product teams, suppliers, and supporting functions to ensure software products and processes meet company requirements and regulatory expectations. It also protects patient ePHI and PII, supports investigations and corrective actions, and trains and mentors engineers. The position reports to a Manager or Senior Manager of Quality Engineering. Listed locations include West Chester, Pennsylvania; Warsaw, Indiana; Raynham, Massachusetts; Palm Beach Gardens, Florida; and Rheinsheim, Germany.

Requirements

• Bachelor’s degree or university degree required.
• At least 4 years of regulated-industry experience in quality, new product development, or manufacturing engineering.
• Ability to apply appropriate quality tools, systems, and processes to meet departmental goals and objectives.
• Demonstrated ability to prioritize and manage multiple projects while meeting deadlines and budgets.
• Ability to perform duties in accordance with policies and procedures and comply with civil rights requirements.
• Ability to work in a team and demonstrate good interpersonal, organizational, and verbal and written communication skills.
• Extensive use of a personal computer and associated work tools, including Word, Excel, and PowerPoint.
• Medical device industry experience.

Nice To Haves

• Advanced degree.
• Degree in Engineering, Computer Science, Information Systems, or Biomedical/Bio-engineering.
• ASQ Certification as a Software Quality Engineer, or equivalent.
• Preferred skills include 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), and technological savvy.

Responsibilities

• Support the design, development, and testing of medical device software, including SaMD products.
• Provide leadership, guidance, and expertise on software development processes, procedures, and practices.
• Partner with R&D to refine requirements and ensure architecture and design documents are comprehensive.
• Facilitate 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; 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 IEC 62304, FDA guidance, FDA Part 11, ISO 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, and HIPAA.
• Guide project teams, suppliers, and other disciplines to ensure compliance with company policies, procedures, and medical device regulations.
• Ensure patient ePHI and PII data is protected and security requirements are met.
• Communicate business-related issues or opportunities to the next management level.
• Follow applicable company Health, Safety, and Environmental guidelines and ensure compliance with applicable laws, regulations, policies, and procedures.
• Perform other duties as assigned.

Benefits

• Consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
• Eligibility to participate in the long-term incentive program.
• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington.
• Holiday pay, including floating holidays: 13 days per calendar year.
• Work, Personal and Family Time: up to 40 hours per calendar year.
• Parental leave: 480 hours within one year of a child’s birth, adoption, or foster care placement.
• Bereavement leave.
• Caregiver leave: 80 hours in a 52-week rolling period.
• Volunteer leave: 32 hours per calendar year.
• Military spouse time-off: 80 hours per calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior