Sr Lifecycle Operations Engineer

Job description

**Job Description Summary**
We are seeking a highly skilled Sr Lifecycle Operations Engineer to lead the design and implementation of engineering solutions that support both the commercialization of new business workflows, and the sustainment of established workflows associated with regulated medical devices and products.

This role requires deep expertise in Quality Management Systems (QMS), infrastructure modernization, and delivery of compliance-critical artifacts to ensure alignment with regulatory standards and enterprise policies.

**Job Description**

**Key Responsibilities:**

**Engineering Solutions & Workflow Enablement**

+ Architect and implement engineering solutions to support **new product introduction (NPI)** and **business workflow commercialization** in regulated medical device environments.
+ Maintain and enhance existing workflows by ensuring infrastructure reliability, scalability, and compliance.
+ Translate business and regulatory requirements into technical solutions that meet QMS and enterprise architecture standards.

**Quality & Compliance Leadership**

+ Author and execute **Validation Plans** , **Verification Plans** , and **Test Protocols** in accordance with ISO 13485 and FDA 21 CFR Part 820.
+ Conduct **Failure Modes and Effects Analysis (FMEA)** and support risk mitigation strategies across infrastructure and application layers.
+ Ensure traceability and documentation of engineering activities to support Design History File (DHF), Device Master Record (DMR), and audit readiness.
+ Participate in internal audits, CAPA investigations, and risk management activities related to infrastructure and system operations.

**Infrastructure Modernization & Cloud Engineering**

+ Lead migration of legacy **web servers and operating systems** to secure, scalable cloud environments.
+ Design and deploy VPCs, EC2 instances, IAM roles, and serverless containers (e.g., AWS Fargate) to support medical device applications.
+ Replace unsupported platforms with compliant alternatives to maintain cybersecurity posture and regulatory alignment.

**DevOps, Security & Automation**

+ Develop CI/CD pipelines using GitLab Runners for automated testing, release and deployment of complex (distributed, multilayered etc.) applications.
+ Create automation scripts for configuration updates with rollback and audit logging to ensure change control compliance.
+ Execute **penetration tests** and **Nessus vulnerability scans** ; analyze and remediate findings in collaboration with InfoSec and platform teams.
+ Support infrastructure provisioning and lifecycle operations for virtual machines used in development and production environments.

**Cross-Functional Collaboration & Technical Support**

+ Partner with Enterprise IT and STO IT teams to align infrastructure with enterprise cybersecurity and QMS policies.
+ Provide technical support and root cause analysis for application failures, startup issues, and system-level anomalies.
+ Mentor junior engineers and contribute to enterprise architecture governance through reusable components and scalable design patterns.

**Cross-Functional Collaboration & Technical Support**

+ Partner with Enterprise IT and STO IT teams to align infrastructure with enterprise cybersecurity and QMS policies.
+ Provide technical support and root cause analysis for application failures, startup issues, and system-level anomalies.
+ Mentor junior engineers and contribute to enterprise architecture governance through reusable components and scalable design patterns.

**Required Qualifications:**

+ Bachelor’s in Engineering, Computer Science, or related field with 10+ years of engineering experience.
+ Strong understanding of **QMS frameworks** (ISO 13485, FDA QSR).
+ Hands-on experience with vSphere, AWS, Linux, Docker, Kubernetes, CI/CD tools, and infrastructure automation.
+ Experience with **OpenStack** , **Redfish** , **RESTful APIs** , and **server hardware** (GPU, CPU, DIMM, PCIe).
+ Familiarity with **cybersecurity frameworks** (e.g., NIST, HIPAA).
+ Experience conducting **penetration testing** , **vulnerability scanning (e.g., Nessus)** , and addressing security findings.

**Preferred Qualifications:**

+ Masters Degree in Engineering, Computer Science, or related field.
+ 5+ years in regulated medical device environments.
+ Engagement Manager or similar leadership certification.
+ Experience with **IaaS, PaaS, and SaaS architectures** , including service orchestration, monitoring, and lifecycle management.
+ Familiarity with **infrastructure automation tools** (e.g., Terraform, Ansible).
+ Exposure to **multi-tenant cloud environments** and **hybrid cloud deployments** .
+ Experience with **compliance automation** , **policy-as-code** , and legacy modernization including **WebLogic-based applications and CentOS systems** .

We will not sponsor individuals for employment visas, now or in the future, for this job opening.


**Additional Information**

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.

GE HealthCare is an Equal Opportunity Employer (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf) .

Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening.

Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

**Relocation Assistance Provided:** No

Required Skill Profession

Other General