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 MedTechFueled 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 Senior Software Design Quality Engineer role to be located at Danvers, MA.The Senior Software Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a key role in product risk management, cybersecurity, change controls, test reviews, 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:
- Drive 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.
- Lead and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Software Failure Modes and Effects Analysis (SFMEA) and Risk Management Reports.
- Drive assessments of 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.
- Ensure that FDA and other regulatory knowledge and experience is applied to risk management, software development and testing.
- Participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing feedback on 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.
- Review and approve Change Requests as needed to release software revisions to production/field.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
- Drive 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.
- Drive compliance of QMS through authoring and updating Standard Operating Procedures (SOP).
QualificationsEducation:- 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 SkillsRequired:- A minimum of 5 years of related work experience within the medical device industry on SaMD and SiMD systems.
- Experience with quality engineering under quality system regulations, including but not limited to 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR.
- Experience with 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 with Class III medical device capital equipment development
- Experience with owning, conducting and maintaining risk management activities, including the risk management file.
- 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.
Required Skills:Preferred Skills:Accelerating, Agility Jumps, Coaching, Communication, Compliance Management, Continuous Improvement, Data Savvy, Disaster Recovery (DR), Econometric Models, Issue Escalation, Problem Solving, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Researching
The anticipated base pay range for this position is :$109,000.00 - $174,800.00
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)).
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
