Systems Engineer jobs in United States, Georgia, Roswell

About the role:
We are seeking a strategic and experiencedto join our Quality team at the Johns Creek site. In this key role, you will serve as the subject matter expert (SME) on the Corrective and Preventive Action (CAPA) system, leading initiatives that enhance our quality systems and ensure compliance with global regulatory requirements. You’ll partner cross-functionally to promote a culture of continuous improvement, audit readiness, and quality accountability—driving Boston Scientific’s mission of transforming lives through innovative medical solutions.

Your responsibilities will include:

• Act as the SME for the CAPA system, managing and mentoring on CAPA and nonconformance processes.
• Lead preparation for and participation in external audits (e.g., FDA, ISO, MDSAP), including coaching staff on audit readiness best practices.
• Serve as a quality representative to increase awareness, visibility, and communication on quality initiatives across departments.
• Provide quality systems support to ensure compliance with Boston Scientific’s Quality System requirements and assess system effectiveness.
• Benchmark and implement best practices tailored to business needs while aligning with regulatory requirements and operational goals.
• Serve as a recognized leader in QSR, cGMP, ISO, and EU MDR standards; collaborate with the QA Director on critical quality decisions.
• Lead and support internal audits; identify opportunities for advancing the Quality Systems at the Johns Creek site.
• Monitor and report on quality metrics that drive continuous improvement and customer satisfaction.
• Champion cross-functional collaboration to align teams on quality and compliance goals.
• Cultivate a culture of accountability, customer focus, and ownership of quality responsibilities.
• Provide coaching and guidance to engineering and technical teams to strengthen quality capabilities.
• Apply structured problem-solving methodologies to address quality issues and communicate resolutions effectively.
• Track action items, report site metrics, and lead Management Review and CAPA Review Board meetings.
• Monitor progress against quality plans and escalate risks to leadership when necessary.
• Advise leadership on strategic quality system improvements that support long-term business objectives.

Required qualifications:

• Minimum of 10+ years experience in a Medical Device, Pharmaceutical or related field including a minimum of 5 years' experience in quality systems, quality engineering, or related function in the medical device industry.
• Demonstrated expertise in QSR, cGMP, ISO 13485, and EU MDR standards.
• Experience leading cross-functional teams and complex compliance projects.
• Ability to travel up to 10% for audits and cross-site initiatives.

Preferred Qualifications:

• Advanced degree (e.g., MS, MBA, MEM)
• Lead Auditor Certification ISO 13485:2016, ASQ CQA or CQM/OE.
• Proven ability to influence without authority and mentor others in quality disciplines.
• Prior experience with eQMS tools (e.g., TrackWise, Agile, MasterControl).
• Previous experience mentoring or leading others in quality system practices.
• Experience with quality metrics and data analysis to drive improvement.
• Prior experience with eQMS tools (e.g., SmartSolve, Windchill, MasterControl) and SAP.
• Previous experience mentoring or leading others in quality system practices.
  Experience with quality metrics and data analysis to drive improvement.

Maximum Salary: $ 188300

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Hybrid Roles:

Key responsibilities include:

• Leads quality team in sustaining activities to support commercial product monitoring on projects of major magnitude and scope. Key Quality voice of influence on projects.
• Leads quality team on functional deliverables and ensures technical excellence for product or technical development.
• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance, key partner in all department goals and objectives. Including leading V&V activities and failure investigations.
• Develops and implements quality strategies; seeks innovative approaches to attaining quality goals, including continuous improvement and VIP.
• Hire, develop, and coach direct and indirect reports to provide technical leadership and support of multiple projects, and drive best practices throughout the organization.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly.
• Maintains and enhances cross-functional team relationships.
• Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues.
• Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
• Directly interfaces with internal and external audit activities.

What we're looking for in you:

Required Qualifications:

• Minimum of a Bachelor's degree
• Minimum of 7 years of related work experience or an equivalent combination of education and work experience
• Proven technical leadership and project management skills in medical device design, development, and commercialization
• Proven independent critical thinker, strong communication skills, strong presentation skills, and ability to build effective cross-functional relationships
• Ability to interface with customers to gather insight and get organizational buy-in on key design inputs
• Knowledge of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations
• Medical Device or regulated industry experience

Preferred qualifications:

• Bachelor in an engineering discipline
• Advanced degree in technical field or business.
• Experience leading technical teams.
• Experience with Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations.
• Familiarity with BSC products and customer needs

About the Role:

The Senior DevOps Engineer will contribute to designing and constructing a scalable cloud architecture. This role will facilitate cross-team services integration and use Infrastructure as Code (IAC) tools for process automation. They will uphold security compliance standards and participate in creating detailed documentation. This is a hybrid role based in our Newtown square office and will require going into the office once a week on Wednesdays, possibly more depending on team activities.

Technical qualifications involve familiarity with cloud-based environments, experience with Kubernetes, Git, and Artifactory, understanding of automation tools like Jenkins, Concourse, Ansible, and GitLab Automation, and proficiency in security software like CrowdStrike and Nexus scanner. The right candidate also understands VPC and networking and is proficient in IaC tooling.

Roles and Responsibilities:

• Design, build, and oversee the maintenance of a secure and scalable cloud architecture that is compliant with industry’s best practices.
• Employ Infrastructure as Code (IAC) tools like Terraform or Ansible to automate processes, enhance productivity, and minimize errors.
• Demonstrate proficiency across major cloud platforms like AWS, GCP, and Azure.
• Configure, build, and deploy containerized services using Docker and/or Kubernetes
• Develop and enforce a secure network infrastructure, aligning with security compliance standards like FedRAMP, FIPS, and STIGs.
• Engage in Research and Development to maintain and enhance the security and functionality of our services.
• Use generative AI elements to increase efficiency and speed, improve accuracy and consistency, enhance security, and better manage resources where practical and within security boundary guidelines.

Technical Skills:

• Knowledge of AWS foundational technologies (EC2, S3, IAM, Route53, VPC)
• Knowledge of VPC, networking, and ability to manage infrastructure setups
• Proficient in using Terraform and Ansible to build modules for deploying applications in AWS, Azure, and/or GCP as IaC
• Familiarity with tools such as Vault, Kubernetes, and Gardener for cluster builds

• Proficient in building Docker Container based workflows

• Expertise in automation tools like Jenkins, Concourse, and GitLab Automation
• Proficient in a scripting or programming language for automation (bash, python)
• Strong Linux OS skills - deployment, configuration, and troubleshooting
• Experience in implementing and automating application testing using Behavior Driven Development (Gherkin) principals with frameworks like Selenium, Cypress, or Playwright.
• Hands-on experience with self-documentation tools

Qualifications:

• Bachelor's or Master's in Computer Science, Information Systems, or related technical disciplines. Years of experience may be used in lieu of a degree.
• Minimum of 5-8+ years of professional experience in a DevOps role.
• Understanding of cloud architectures and services with relevant experience in cloud platforms like AWS, GCP, or Azure.
• Exceptional problem-solving skills and ability to work under tight deadlines.
• Strong written and verbal communication skills.
• Demonstrable experience in managing cross-functional projects.
• Previous experience with QA processes and setting up a complete QA system will be considered a plus.
• Must reside within commuting distance to be able to go into the Newtown Square PA office at least once a week and willingness to go more depending on team activities.

We win with inclusion

Philadelphia

As a Senior Java Engineer (f/m/d), you will play a key role in designing, building, and scaling enterprise-grade software products with real impact for Signavio customers.
You’ll be joining a high-performing team where your expertise in backend development and software architecture will directly shape the product roadmap and user experience.

What you bring

• 6+ years of professional software engineering experience
• Expert-level proficiency in Java and Spring Boot, with a deep understanding of backend application architecture and performance tuning
• Solid experience with relational databases such as PostgreSQL or similar
• Strong working knowledge of REST APIs, software testing, and CI/CD practices
• Proficiency in Git, debugging tools, and collaborative development workflows
• A proven track record of building scalable and maintainable production systems
• Experience mentoring and leading junior developers in a team setting
• Strong communication skills in English (German is a plus, but not required)

The following experience would be a plus:

• Experience with cloud platforms (e.g., AWS, GCP, or Azure)
• Familiarity with microservices architecture and distributed systems
• Exposure to frontend technologies such as TypeScript or React
• Interest or background in Business Process Management, Process Mining, or related fields
• Entrepreneurial mindset or experience working in startup environments
• Experience working with remote or globally distributed teams

Please include a public GitHub profile with repositories containing Java code you have written in your application. Also please bring the willingness and ability to share and defend non-trivial code from past projects during the interview process.

You'll work alongside creative thinkers who share your interests in an environment that encourages free and open expression of ideas.

Job Segment:Cloud, Developer, Java, ERP, Testing, Technology

to meet diverse organization requirements.

What you´ll do

Design,implement,and manage cloud-based database solutions using: HANA, Hadoop, Redis, Kafka, and Cassandra

Design,implement,and manage cloud-based database solutions in our portfolio.

Automate database provisioning and configuration using Git,Terraform,Ansible, Jenkins

Drive innovation and the adoption of new technologies in the organization to increase operational efficiency, scalability, agility, and continuous improvement feedback loops.

Troubleshoot and resolve database performance issues.

What you bring

3+ years' experience administering high throughput, highly available, transactional database systems covering designing, installation, trouble shooting, and performance and tuning.

Experience with automated deployments of databases using Jenkins, Terraform, Ansible or similar.

Automation-related experience with at least one of: Python; Bash; Go

Experience with database operation and deployments in one of: Google Cloud Platform

(Preferred); AWS or Azure

Strong problem-solving and analytical skills.

B.S. or higher in Computer Science or other technical discipline

Can-Do Attitude

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