Manager, Software Design Quality Engineering - Johnson and Johnson
Danvers, MA 01923
About the Job
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/ .
Position Summary:
The Software Design Quality Engineering Manager leads a team utilizing Software Design Quality Engineering, and Risk Management techniques and expertise to provide management and functional support for the entire software development life cycle (SDLC) of Abiomed's software products. This position also supports company compliance with applicable federal, industry, and corporate procedures, guidelines, and regulations during the design, development, test, and installation of software products and the software aproducts for US and ROW.
Primary Duties and Responsibilities:
- Lead Software Design Quality Engineering team in support of Abiomed's Product Development and Software Development Life Cycle processes for various medical device projects. Including Software in Medical Device (SiMD), MDDS, CDS, IoT, Multi-function devices, and SaMD projects.
- Accountable for the Software Risk Management, Software Development Lifecycle, Design Control, and Change Control processes.
- Represent the Software Design Quality Engineering function in Notified Body and Regulatory body audits/inspections
- Design and implement process improvements for the Software Design Quality Engineering function, in areas such as design controls, change control, risk management, and software anomaly tracking.
- Define and communicate overall objectives for the Software Design Quality team.
- Manage long and short-term planning for the Software Design Quality Engineering team, including training, development, and goal setting.
- Build and maintain strong interpersonal relationships within and outside of the business unit.
- Support and ensure adherence to Abiomed's product cybersecurity processes.
- Ensure robust processes are employed in new product development.
- Provide input and leadership for Quality policies, approaches, and standard practices.
- Support maintaining alignment with US and International regulations and standards, as well as Abiomed quality systems.
- Identify opportunities to proactively assure compliance to all applicable internal, domestic, and international quality regulations, US 21 CFR 820 (QSR), EU MDR, ISO 13485, ISO 14971, IEC 62304, etc.
- Bachelor's degree in sciences or engineering with minimum 8 years in quality desired with at least 2 years in a leadership role
- Must have software quality experience working with and on Software Safety Class C medical device products, FDA Class III or II medical devices
- Experience with Domestic and International regulatory requirements and working with regulating bodies.
- Working knowledge and practical application of relevant requirements of 21 CFR Part 820, EU MDR, ISO and IEC standards
- Strong leadership skills with demonstrated ability to create momentum and deliver excellent results.
- Ability to work in a matrixed and geographically diverse business in a fast-paced changing environment
- Ability to set goals and provide constructive feedback respectfully to build positive relationships and improve business results.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner.
- Strong organizational, planning, and follow-up skills and ability to hold others accountable.
- Ability to travel approximately 10%, including the potential for international travel.
- Nice to have cardiovascular medical device, Software as a Medical Device (SaMD), and Medical Device Data System (MDDS) experience.
- Familiarity with TIR45 and Agile Software Development methodologies.
- Nice to have certifications in ASQ SQE, SixSigma Black belt, Agile software development, and/or other scrum processes.
- Experience using requirements, test management, and work tracking tools, such as Jama and Jira.
• This position may require up to 10% domestic travel.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]