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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:

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*

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position has the following 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.

Additionally:

o   Responsible for communicating business related issues or opportunities to next management level

o   Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

o   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

o   Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

o   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·       Potential internal interfaces that this role may encounter include:o   Interfacing with other Quality Team memberso   Working with Research & Development on product issueso   Working with Product Owners on product requirementso   Working with Program Management on product scheduleso   Working with other product teams to support other products or platformso   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