Sr Eng RD Soft Eng

Johnson & Johnson Innovative Medicine; Boston (MA); On-site; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking a Senior Quality Engineer to lead quality efforts on medical device software development. You will oversee requirements, risk assessments, test strategies, and design controls while guiding project teams through regulatory compliance.

In this role, you will support regulatory filings, investigations of CAPAs, and audits, mentoring junior staff and ensuring protection of patient data. A strong background in IEC 62304 and ISO 13485 is expected.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• Minimum 4 years in quality, new product development, or manufacturing engineering in a regulated industry.

Responsibilities

• Lead quality activities on medical device software development projects.
• Provide guidance on software risk assessments and design controls.
• Support regulatory filings and inspections; manage CAPAs and non-conformances.

Skills

Software quality

Regulated industry

Quality tools

Team collaboration

Communications

Education

Bachelor's degree

Advanced degree preferred

Tools

ASQ Certification

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.com

As 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:

Senior Quality Engineer, Product Software Development

Synthes or DePuy; West Chester, PA or Warsaw, IN or Raynham, MA or Palm Beach Gardens, FL or Rheinsheim, Germany

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:

Senior Quality Engineer, Product Software Development

Synthes 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*

• 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 practices
• Partner 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.

• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

• 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 applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• 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.
• Interfacing with other Quality Team members
• Working with Research & Development on product issues
• Working with Product Owners on product requirements
• Working with Program Management on product schedules
• Working with other product teams to support other products or platform
• 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 - $174,800.00

Additional 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
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• 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 the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

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