Senior Software Quality Engineer, Instruments & Accessories - 2406185648W

Description

J&J MedTech is recruiting for a Senior Software Quality Engineer, Instruments & Accessories. This position can be located in Santa Clara or Irvine, California or Cincinnati, Ohio!

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 https://www.jnj.com .

This role is responsible for supporting product quality and reliability ensuring the implementation of ground-breaking technology for medical devices is safe and effective, while following applicable regulations, standards, and industry practices! Working closely with multi-functional teams, you will act as a domain authority for product quality throughout the development lifecycle. You will review 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 supporting other areas of our 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).

• Provide 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.

• Identify and implement any changes vital to ensure and maintain the continued suitability and effectiveness of the quality system using policies, objectives, audit results, and analysis of data.

• Support internal and external audits by regulatory agencies, as needed.

• Communicate business related issues or opportunities to next management level.

• Ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Adhere to good documentation practices including change control.

Qualifications

Education:

• University/Bachelor’s degree or equivalent in Engineering, Computer Science or STEM (Science, Technology, Engineering, Math) related field.

Experience and Skills:

Required:

• Minimum four (4) years of related experience that includes New Product Development.

• Quality Assurance with a focus on software testing, design controls, software development, and or software verification & validation experience.

• Experience in medical device industry or other highly regulated field (Aerospace, Aviation, Automotive, Defense).

• Proven verbal and written communication skills; ability to present issues, plans and objectives while using experience of engaging in a team-based environment.

• Knowledgable and demonstrated 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.

Preferred:

• 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.

• Experience working on consumer electronic equipment.

Other:

This position may require up to 10% domestic and/or international travel.

The anticipated base pay range for this position is $104,000 to $166,750.

The anticipated base pay range for the Santa Clara, CA location is $119,000 to $191,820.

• 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

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on May 17, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com (https://jnjc.taleo.net/enterprise/www.careers.jnj.com) .

Primary Location NA-US-California-Santa Clara

Other Locations NA-US-California-Irvine, NA-US-Ohio-Cincinnati

Organization Ethicon Endo Surgery Inc (6041)

Travel Yes, 10 % of the Time

Job Function R&D Software/Systems Engineering

Req ID: 2406185648W