Product Software Development, Staff QE (Medical Device Software)

Location: Raynham, Massachusetts, United States; additional job posting locations include Boston, Massachusetts, United States and Gières, Isère, France.

Base pay: $109,000–$174,800 per year.

Company

Johnson & Johnson MedTech develops healthcare and medical device solutions, including innovative technologies for complex diseases and less-invasive treatment.

What you will do

• Lead quality activities for medical device software, including Software as a Medical Device and Software in Medical Device products.
• Guide requirements refinement, architecture and design documentation, verification activities, test strategy, code review findings, and defect management.
• Facilitate software risk assessments and maintain risk documentation.
• Support regulatory filings, product registrations, audits, inspections, supplier audits, non-conformances, CAPAs, and root-cause investigations.
• Provide guidance on software quality processes, design controls, industry standards, and medical device regulations.
• Train and mentor new and lower-level quality engineers and project team members.

Requirements

• Bachelor’s or university degree required; engineering, computer science, information systems, biomedical engineering, or bioengineering preferred.
• At least 6 years of regulated-industry experience in quality, new product development, or manufacturing engineering.
• Experience with medical device software, SaMD, or software development life cycle processes strongly preferred.
• Previous leadership, coaching, or mentoring experience with engineers or project team members.
• Ability to manage multiple projects, prioritize work, meet deadlines and budgets, and collaborate across functions.
• Knowledge of medical device industry practices and strong written, verbal, organizational, and interpersonal skills required.

Nice to have

• Advanced degree.
• ASQ Software Quality Engineer certification or equivalent.
• Experience with Model-Based Systems Engineering, SAP Product Lifecycle Management, scripting languages, software architectures, and software engineering practices.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and employee merit.
• Participation in retirement, pension, savings, and 401(k) plans, subject to plan terms.
• Eligibility for the long-term incentive program.
• Vacation, sick time, holidays, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time-off benefits.