Software Design Quality Engineer II

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 II role to be located at Danvers, MA.

The ideal candidate for the Software Design Quality Engineer II 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. The engineer should have the ability to work with autonomy while exceling 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 quality focused design and development of software within the software development lifecycle (Agile/waterfall/SAFe/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability.

• Use Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) technical expertise, knowledge, and experience to rapidly innovate the company’s medical devices for use in chronic heart failure patients.

• Drive 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 and assess 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.

• Ensure that Design Controls are compliant with IEC 62304.

• Proactively participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing technical feedback of software verification and validation activities.

• Develop and/or review test protocols, reports, and engineering summaries

• Contribute 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).

• Performs other duties assigned as needed

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 2 years of related work experience.

• Intermediate knowledge of quality system regulation, including 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR.

• Intermediate knowledge of Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) systems.

• Intermediate 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 internationally.

Preferred:

• Work experience in a highly regulated industry

• Experience conducting Hazard Analysis and Software Failure Mode Effects and Analysis

• Design control and/or new product development experience

• Experience with JAMA and Atlassian suite of tools (JIRA/Confluence)

• Experience with cybersecurity within a regulated industry.

Other:

• 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  ([email protected]) or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Agility Jumps, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Database Backup, Data Savvy, Disruptive Innovations, Issue Escalation, Problem Solving, Process Oriented, Product Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

The anticipated base pay range for this position is :

$92,000.00 - $148,350.00

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