Senior Software Quality Engineer
Location
Santa Clara, CA | United States
Job description
J&J MedTech is recruiting for a Senior Software Quality Engineer. This position can be located in Santa Clara, CA or Cincinnati, OH .
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
The Senior Software Quality Engineer is responsible for supporting product quality and reliability ensuring the implementation of ground-breaking technology for medical devices is safe, effective, and follows applicable regulations, standards, and industry practices. Working closely with multi-functional teams, this individual will act as a domain authority for product quality throughout the development lifecycle. The individual reviews and assesses development activities (e.g., user needs, development / quality plans, requirements, architecture and design, verification and validation) to ensure that they align with applicable procedures standards and regulatory requirements. Additional responsibilities may include but are not limited to supporting other areas of the Quality Management System such as CAPA, Complaints, post market surveillance and both Internal & External Audits.
Key Responsibilities: - Review all project/program software development artifacts (e.g., plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports).
- Provides direction and leadership for verification & validation of non-product software, products software, software tools and components.
- Guide in establishing good software requirements, specifications, detailed design, verification & validation protocols and planning documentation.
- Collaborate with project/program teams to ensure software deliverables and tasks align with company procedures, global standards (ISO 13485, ISO14971, IEC62304), regulations (e.g., 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Regulation (MDR)), and applicable guidance.
- Participate in technical design reviews and project phase reviews.
- Apply knowledge of risk management to ensure a risk-based approach for design and development.
- Identifies and implements any changes vital to ensure and maintain the continued suitability and effectiveness of the quality management system using quality policy, quality objectives, audit results, analysis of data, etc.
- Support internal and external audits by regulatory agencies, as required.
- Responsible for communicating business related issues or opportunities to next management level.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Good documentation practices including change control.
- Other duties as assigned.
Education: - University/Bachelor's degree or equivalent in Engineering, Computer Science or STEM (Science, Technology, Engineering, Math) related field required.
Experience and Skills: Required: - Minimum four (4) years of relevant experience
- Experience with Quality Assurance with a focus on software testing, design controls, software development, and or software verification & validation
- Experience in medical device industry or other highly regulated field (Aerospace, Aviation, Automotive, Defense)
- New product development experience
- Strong verbal and written communication skills; ability to present issues, plans and objectives
- Knowledge and proven application of standards such as IEC62304, FDA's General Principles of Software Validation, ISO 14971, and IEC60601-1
- Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms
- Previous work experience engaging in a team-based environment
Preferred: - Advanced Degree
- ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean)
- Experience with FPGA logic (VHDL, Verilog) and architectures
- Prior experience working on consumer electronic equipment
Other: - Ability to travel up to 10% required
- The anticipated base pay range for this position is $90,000 to $144,900
- The anticipated base pay range for this position is, in the Bay Area, is $105,000 to $166,635
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be 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.
- Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: This job posting is anticipated to close on
March 1, 2024. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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