Software Design Quality Engineer

Johnson & Johnson Innovative Medicine-posted 4 days ago
$74,000 - $119,600/Yr
Full-time
Danvers, MA
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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. We are searching for the best talent for Software Design Quality Engineer role to be located at Danvers, MA. The ideal candidate for the Software Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a role in product risk management, cybersecurity, change controls, and design controls. This engineer should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. Be ready to make a significant contribution to a dynamic, fun, multi-disciplinary team, where a self-motivated engineer with excellent written and verbal communication skills stands ready to succeed.

  • 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.
  • 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.
  • 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.
  • 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).
  • A minimum of a Bachelor's degree in an engineering or scientific discipline is required.
  • 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.
  • 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.
  • Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
  • 401(k) retirement plan and savings plan.
  • Long-term incentive program.
  • Vacation – 120 hours per calendar year.
  • Sick time - 40 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.
  • Condolence Leave – 30 days for an immediate family member; 5 days for an extended family member.
  • Caregiver Leave – 10 days.
  • Volunteer Leave – 4 days.
  • Military Spouse Time-Off – 80 hours.
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