Sr Lifecycle Operations Engineer
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Job Location:
Waukesha, WI - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 supportnew product introduction (NPI)andbusiness workflow commercializationin 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 executeValidation PlansVerification Plans andTest Protocolsin accordance with ISO 13485 and FDA 21 CFR Part 820.
- ConductFailure 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 legacyweb servers and operating systemsto 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.
- Executepenetration testsandNessus 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:
- Bachelors in Engineering Computer Science or related field with 10 years of engineering experience.
- Strong understanding ofQMS frameworks(ISO 13485 FDA QSR).
- Hands-on experience with vSphere AWS Linux Docker Kubernetes CI/CD tools and infrastructure automation.
- Experience withOpenStackRedfishRESTful APIs andserver hardware(GPU CPU DIMM PCIe).
- Familiarity withcybersecurity frameworks(e.g. NIST HIPAA).
- Experience conductingpenetration testingvulnerability 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 withIaaS PaaS and SaaS architectures including service orchestration monitoring and lifecycle management.
- Familiarity withinfrastructure automation tools(e.g. Terraform Ansible).
- Exposure tomulti-tenant cloud environmentsandhybrid cloud deployments.
- Experience withcompliance automationpolicy-as-code and legacy modernization includingWebLogic-based applications and CentOS systems.
Additional Information
GE HealthCare offers a great work environment professional development challenging careers and competitive compensation. GE HealthCare is anEqual Opportunity Employer. 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 Experience:
Senior IC
Key Skills
- Change Management
- Software Deployment
- Cloud Infrastructure
- High Availability
- IaaS
- Firewall
- Linux
- Middleware
- Jboss
- Network Architecture
- Scripting
- Technical Support
About Company
As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence With over 100 years of healthc ... View more
