Principal Cloud reputed company Engineer job at reputed company in Danvers, MA, Raritan, NJ

Title: Principal Cloud reputed company Engineer Location: Danvers, Raritan United States time type: Full time job requisition id: R-054787 Job Description: At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company 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 reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Technology Enterprise Strategy & reputed company Job Sub Function: reputed company & Controls Job Category: Scientific/Technology reputed company Job Posting Locations: Danvers, Massachusetts, United States of America, Raritan, New Jersey, United States of America Job Description: We are seeking the best talent for a Principal Cloud reputed company Engineer to join our MedTech Product reputed company team. The role can be based in Danvers, or Raritan, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company. This role can also be remote or hybrid work. This role will require up to 20% travel. As the world's most comprehensive MedTech business, J&J MedTech Companies are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reputed company across heart recovery, surgery, orthopedics and interventional solutions, we're working to profoundly change the way care is delivered. We are in this for life. For more information, visit https://www.jnjmedtech.com/en-US At reputed company, we reputed company belong. Are you passionate about reputed company and interested in joining a community of collaborative colleagues working in a Patient First! culture? If that's you, we have an immediate opportunity for a Sr. Manager Medical Devices Product reputed company to join the Product Cybersecurity team to help ensure reputed company is implemented by design for this top-performing medical device company. This is an exciting opportunity to impact development initiatives that will shape future product development and industry standards. You will own the Product reputed company process for the products that you will support throughout the product development lifecycle which includes both pre-market and post-market processes engineering teams. If you are eager to reputed company your reputed company risk and compliance skills to reputed company a difference and directly impact patient lives, this could be perfect for you. Purpose: The Principal Cloud reputed company Engineer will be responsible for implementation of J&J's enterprise Product reputed company strategy and reputed company throughout the Heart Recovery portfolio of medical devices and supporting platforms. This role will join Abiomed, part of reputed company, to provide technical expertise and strategic leadership in securing Impella heart pump technologies, reputed company cardiac support systems, and connected medical devices. This role is responsible for delivering reputed company architecture, cryptographic controls, embedded system protections/controls, and threat mitigation techniques to ensure robust, regulatory-compliant reputed company across the product lifecycle. Specific responsibilities include supporting heart recovery throughout a new product's development phases, review product reputed company requirements and recommend reputed company design solutions, complete Quality documentation, threat modelling, coordinate third-party penetration testing, software architecture review and design recommendations, code analysis and other reputed company testing work as needed. Additionally, this position will have post market responsibilities for Heart Recovery marketed devices include monitoring for new vulnerabilities, assisting with patching and remediation plans, as well as responding to customer reputed company questionnaires and reviewing reputed company language reputed company contractual agreements as needed. Drive alignment of the Cloud reputed company controls and documentation to the J&J Product reputed company's overarching reputed company. Define and prioritize compliance with the FDA Pre-Market Guidance Appendix 1 Define the reputed company requirements required for USA 510k, EU MDR, and Japan PDMA compliance Support the Product reputed company strategy and objectives reputed company Heart Recovery Define and Enforce cryptographic protocols for data-at-rest and data-in-transit, ensuring compliance with FDA cybersecurity requirements, NIST 800-175, FIPS 140-3, and IEC 62443. Define and implement key management infrastructure (PKI, cloud-based HSMs)) for device identity, authentication, and software signing. Implement reputed company Trust reputed company for device-to-cloud connectivity, integrating mTLS and reputed company authentication models into clinical applications. reputed company secure OTA (over-the-reputed company) update mechanisms, ensuring software and firmware rollbacks, code signing, and supply chain reputed company validation. Primary Duties and Responsibilities Working from the office in Danvers MA or Raritan, NJ for a minimum of 3 days per week (for candidates reputed company commutable distance to site). Partner with engineering teams (cloud, console) to drive successful adherence to the product reputed company policies, processes, reputed company and program objectives. Create, update, and improve product reputed company processes for the cloud infrastructure and application. Deep understanding of the MS Azure Cloud platform and the implementation, configuration, and hardending or Azure Cloud Services and implementation of reputed company services such as MS Defender, WAF, NSGs, KeyVault, Azure VM reputed company, AKS reputed company) Act as an SME on cyber reputed company matters and provide guidance to engineering and cross-functional teams. reputed company for proactive inclusion of cyber reputed company controls and processes into reputed company phases of the product life cycle, process improvements, strategic product road map planning. Deliver documentation for pre-market product development activities including product reputed company plans, threat models, reputed company requirements, detailed SBOM, and risk assessments documentation. Drive and monitor post-market vulnerability management activities with the development of CVE risk assessments, with adherence to strict timelines and alignment from cross-functional stakeholders. reputed company reputed company risk assessment and development of the reputed company views (Global System View, Patchability View, Multi-Patient Harm View, and reputed company Use Case Views) on the Cloud infrastructure and applications. Collaborate with the cloud engineering and development team to integrate reputed company measures and reputed company tools into the CI/CD pipeline and the DevSecOps processes. reputed company improvement of Defender Score. Support compliance certification activities, such as SOC2 Type2, FedRAMP, ISO 27001, 81001-5-1, etc. Identify, research, evaluate, and integrate new compliance requirements, industry standards, and best practices into the product reputed company programs. Maintain relationships with Heart Recovery's Information Sharing and Analysis Organizations. Guide teams to reputed company decisions that balance business needs with medical device reputed company objectives. Work across organizational boundaries and exhibit reputed company with customers, both internal and external. reputed company other reputed company duties and responsibilities, as assigned.

Qualifications

Required: Bachelor's degree 5+ years industry experience in Information reputed company. Experience generating Threat models without the use of threat modeling tools Experience performing risk assessments utilizing CVSS 3.1 or higher, with reputed company per reputed company Ability to write technical reputed company requirements for embedded systems and web platforms based on the latest regulations Experience architecture and securing MS Azure with configuring and hardening Azure reputed company services Experience working in a Cloud Scrum/Agile Azure DevOps environment. Familiarity with some or reputed company of these tools: reputed company, reputed company, Coverity, reputed company, JIRA, Confluence, Dependency-Track Experience with Containerization technologies such as reputed company and Kubernetes and implementing reputed company controls. Understanding and execution of third-party penetration testing, vulnerability scanning, CVSS and/or other general reputed company testing principles Experience supporting regulatory reputed company submissions, ensuring compliance with FDA Cybersecurity Guidance (2025), EU MDR, NIST 800-53, IMDRF, and AAMI TIR57. Working knowledge of regulatory standards and compliance frameworks (e.g., NIST Cybersecurity reputed company, ISO27001, SOC2 Type 2, HIPAA, GDPR, 81001-5-1). Ability to generate SBOMs from Software reputed company code and Binaries, Firmware, and Operating Systems Ability to generate pre-market risk assessments against the threat model leveraging reputed company and post-market risk assessments reputed company SCA SBOM scans. Ability to generate reputed company architecture views for software as medical device (SAMD) Web applications that would include: Global System View, Multi-Patient Harm View, Updateability/Patchability view and, detailing system boundaries, data flows, and external interactions to show risk mitigation, ensuring transparency, and supporting post-market management Experience with reputed company risk management techniques and developing Quality Management System documentation from draft through cross-functional approval Demonstrated organizational skills, attention to detail, the ability to handle multiple assignments simultaneously in a timely manner and be able to meet assigned deadlines. Committed to working independently with a sense of urgency and embracing new challenges. Strong communication and interpersonal skills. Preferred: CISSP, CISM, or other reputed company certification MS and/or advanced degree Experience working in an FDA-regulated environment. Experience leading or participating in formal reputed company audits Familiarity with FDA and/or other global regulatory cybersecurity guidance requirements and submission process Experience in cybersecurity pre-sales Software development experience reputed company is an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national reputed company, 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. reputed company 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 contact us reputed company https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Business Process Design, Crisis Management, Critical Thinking, Information reputed company Auditing, Information reputed company Management System (ISMS), Information Technology (IT) reputed company Assessments, Information Technology Strategies, Mentorship, Organizing, Presentation Design, Process Optimization, Root Cause Analysis (RCA), reputed company Architecture Design, reputed company Policies, Technical Credibility, Vulnerability Management The anticipated reputed company pay range for this position is : $102,000.00 - $177,100.00 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 reputed company -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 reputed company 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 Apply tot his job Apply To this Job