Sr Eng RD Soft Eng

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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

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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:

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

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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

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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-lev...