Software Design Quality Engineer

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

Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

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.

Seize the opportunity today to join this collaborative, high performing team within the fastest growing business in MedTech.  Come join our Abiomed team today!

Key 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 companies’ 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

Education:

• 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.

Experience and Skills

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 re