WayUp
Johnson & Johnson, Software Design Quality Engineer - Application via WayUp
WayUp, Danvers, Massachusetts, us, 01923
Overview
Johnson & Johnson, Software Design Quality Engineer - Application via WayUp. This role is with Johnson & Johnson. WayUp is partnering with Johnson & Johnson to hire top talent.
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
Responsibilities
Support design and development activities within the software development lifecycle for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) products.
Use technical expertise, knowledge, and experience to rapidly innovate the company’s medical devices for use in chronic heart failure patients.
Facilitate and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Software Failure Modes and Effects Analysis (SFMEA) and Risk Management Reports.
Evaluate end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets which include but are not limited to software detailed designs, software architecture and specifications.
Participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing feedback of software verification and validation deliverables.
Develop and/or review test protocols, reports, and engineering summaries.
Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
Contribute to the success of the Quality System performance measures by completing tasks on time and with a high level of quality.
Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system as necessary.
Support 3rd party audits, including follow-up on actions.
Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).
Qualifications
A minimum of a Bachelor's degree in an engineering or scientific discipline is required. An advanced degree in a related field is also an asset.
A minimum of 6 months of related work experience.
Knowledge of quality system regulation, including 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR.
Knowledge of Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) systems.
Knowledge of software development lifecycle processes (waterfall, agile, and DevOps) as applied within the regulated medical device industry.
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international.
Preferred
Work experience in a highly regulated industry.
Experience conducting Software Failure Mode Effects and Analysis.
Design control or new product development experience.
Experience with JAMA and Atlassian suite of tools (JIRA/Confluence).
Experience with cybersecurity within a regulated industry.
This position will require to work hybrid in Danvers, MA with a minimum of 3 days per week and will require 10% of domestic and/or international travel.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
Compensation The anticipated base pay range for this position is: $74,000 to $119,600
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Technology, Information and Internet
#J-18808-Ljbffr
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
Responsibilities
Support design and development activities within the software development lifecycle for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) products.
Use technical expertise, knowledge, and experience to rapidly innovate the company’s medical devices for use in chronic heart failure patients.
Facilitate and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Software Failure Modes and Effects Analysis (SFMEA) and Risk Management Reports.
Evaluate end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets which include but are not limited to software detailed designs, software architecture and specifications.
Participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing feedback of software verification and validation deliverables.
Develop and/or review test protocols, reports, and engineering summaries.
Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
Contribute to the success of the Quality System performance measures by completing tasks on time and with a high level of quality.
Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system as necessary.
Support 3rd party audits, including follow-up on actions.
Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).
Qualifications
A minimum of a Bachelor's degree in an engineering or scientific discipline is required. An advanced degree in a related field is also an asset.
A minimum of 6 months of related work experience.
Knowledge of quality system regulation, including 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR.
Knowledge of Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) systems.
Knowledge of software development lifecycle processes (waterfall, agile, and DevOps) as applied within the regulated medical device industry.
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international.
Preferred
Work experience in a highly regulated industry.
Experience conducting Software Failure Mode Effects and Analysis.
Design control or new product development experience.
Experience with JAMA and Atlassian suite of tools (JIRA/Confluence).
Experience with cybersecurity within a regulated industry.
This position will require to work hybrid in Danvers, MA with a minimum of 3 days per week and will require 10% of domestic and/or international travel.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
Compensation The anticipated base pay range for this position is: $74,000 to $119,600
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Technology, Information and Internet
#J-18808-Ljbffr