Job Description
Job Description
*******LOCAL CANDIDATE ONLY OR OPEN TO RELOCATE TO Pleasanton, CA*NO C2C CANDIDATES**********
Job ID: 46626
Position Summary
Position is for a senior-level individual contributor responsible for leading and executing software-level activities for complex, regulated medical devices. This role focuses on capturing and translating customer and stakeholder requirements into clear, actionable requirements and specifications, ensuring alignment across development and testing teams. Acting as a subject matter expert, this role provides technical leadership and guidance to deliver high-quality software solutions that meet regulatory standards and customer needs.
Based in Pleasanton, CA, the role requires strong technical depth, systems thinking, and the ability to operate with minimal supervision. The engineer collaborates closely with cross-functional teams—including Systems, Software, Quality, Clinical, and Regulatory—and coordinates with global engineering personnel to ensure alignment, resolve interdependencies, and drive successful project completion.
Responsibilities
- Collaborate with cross-functional stakeholders (clinical, regulatory, engineering, and commercial teams) to define product vision, business objectives, and high-level requirements for cloud and mobile solutions supporting heart failure management.
- Own end-to-end requirements definition, translating user needs and intended use into detailed software/system requirements, functional specifications, and interface definitions that are testable, traceable, and compliant with regulatory standards (e.g., FDA, IEC 62304).
- Lead and facilitate design and technical reviews, ensuring alignment with system architecture, requirements integrity, risk controls, and compliance with quality system processes and design controls.
- Partner closely with Systems Engineering, Software Development, and Verification/Validation teams to ensure requirements are clear, decomposed, allocatable, testable, and integrable across subsystems.
- Contribute to risk management activities, including hazard analysis, FMEA, and risk assessments (ISO 14971); ensure risk mitigations are properly captured in requirements, design, and verification plans.
- Actively participate in cross-functional and leadership reviews, providing clear visibility into product progress, system performance, risks, and compliance status.
- Foster strong collaboration and communication across all levels of the organization, including internal teams, customers, vendors, and external partners.
- Develop and apply an expert understanding of designated systems as well as serve as a subject matter expert to solve problems and deliver upon business objectives.
- Communicate integration risks, technical tradeoffs, and system impacts and ensure compliance with applicable quality system requirements.
Education and Experience
Required
- Bachelor’s degree in Systems Engineering, Biomedical Engineering, Software Engineering, Computer Science, or a related technical field with 5-6 years of relevant experience, OR
- Master’s degree in a related technical field with a minimum of 4 years of relevant experience.
- Demonstrated experience collaborating with internal stakeholders to understand business objectives and high-level product requirements, then convert them into detailed software requirements, functional specifications, and interface definitions.
- Experience working in regulated product development environments (medical devices strongly preferred, aerospace, automotive, or similar also acceptable).
- Hands-on experience collaborating across engineering disciplines.
- Working knowledge of design control, configuration management, defect tracking, and change management processes.
- Excellent written and verbal communication skills, with the ability to clearly communicate complex technical concepts to cross-functional stakeholders.
- Proven ability to work independently, prioritize effectively, and drive results in a matrixed organization.
Preferred
- Medical device experience, particularly with connected or software-enabled medical devices.
- Working knowledge of cloud-based platforms (AWS, Azure, GCP) and mobile application ecosystems.
- Experience working with requirements, configuration, and defect management tools (e.g., DOORS, JIRA, etc.).
- Familiarity with relevant standards such as IEC 62304 (Software Lifecycle), IEC 60601, ISO 14971, or similar.
Hard Requirements (3–5)
- Experience working in regulated product development environments (medical devices strongly preferred, aerospace, automotive, or similar also acceptable).
- Working knowledge of design control, configuration management, defect tracking, and change management processes.
- Demonstrated experience collaborating with internal stakeholders to understand business objectives and high-level product requirements, then convert them into detailed software requirements, functional specifications, and interface definitions.
- Hands-on experience collaborating across engineering disciplines.
- Bachelor's degree with 5-6 years of relevant experience or Master's degree with 4+ years of relevant experience.
Preferred Requirements
- Working knowledge of cloud-based platforms (AWS, Azure, GCP) and mobile application ecosystems.
- Experience working with requirements, configuration, and defect management tools (e.g., DOORS, JIRA, etc.).
- Familiarity with relevant standards such as IEC 62304 (Software Lifecycle), IEC 60601, ISO 14971, or similar.
- Medical device experience, particularly with connected or software-enabled medical devices.
Daily Tasks / Duties
- Define and manage software/system requirements and functional specifications.
- Collaborate with Systems Engineering, Software Development, Verification & Validation, Quality, Clinical, Regulatory, and Commercial teams.
- Lead design and technical reviews.
- Support risk management activities including hazard analysis, FMEA, and risk assessments.
- Ensure compliance with design controls, quality system processes, and regulatory requirements.
- Communicate technical tradeoffs, integration risks, and system impacts to stakeholders.
- Participate in leadership and cross-functional reviews to provide project status, risks, and compliance updates.
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The Senior Windows Server Engineer is a subject matter expert that has global accountability for the architecture and design of Windows Services running on Windows 2008R2 and Windows 2012R2 & 2016 R2 in a VMware virtual machine environment. This person must be a Microsoft Windows Server technology expert who can operate and continuously improve, standardize, and automate tasks in environments distributed across datacenters throughout the world. They should have a good understanding of Microsoft Clustering, Terminal services, security, PowerShell scripting and Windows Update Services (WSUS). This engineer should possess the ability perform audits using Microsoft toolkits and native tools to identify security risks in our windows environments. They should be able to articulate technical problems to management, and work well in a team and in cooperation with other teams. They will be working in a fast paced environment that will require travel within and outside of the US a few times a year.
Duties will include:
· Windows Operating System (build, administration, security, and automation tools)
· Windows performance troubleshooting and performance tuning
· Design, implementation, Migration and maintenance of Active Directory, DNS, DHCP, IIS, Group Policy, Clustering, Terminal Services, LDAP and windows scripting/automation.
· Support Applications on Windows OS platform such as SFTP.
· Deploy patches using WSUS and other deployment tools
· Educate the frontline L1 and L2 staff and be the point of escalation
Requirements:
· 5+ years of hands-on experience with Windows, Clustering & Active directory Services with a thorough understanding of installing, designing, configuring, and troubleshooting.
· Understands how to design and document a Windows server configuration useable by team members of various skill levels.
· Must possess proven experience working in an enterprise distributed computing environment with standards, and processes. These experiences should include:
· Technical infrastructure architect/design/support for Windows Server operating systems and a Strong understanding of architecting and configuring Microsoft Windows OS technology
· Problem solving leadership based on experience with technology
· Support of a distributed MS Windows-based network
· Strong record of operational success managing Windows Server services including outstanding troubleshooting and root cause analysis.
· Functional skills in basic protocol analysis, and IP addressing and routing.
· PowerShell or other development/scripting experience.
· Process oriented and a willingness to develop and enhance existing processes, standards, and documentation.
· Motivated to work in a fast paced environment with many challenges
· Strong skills in setting up Microsoft cluster services on Cisco UCS blade servers and VMware / XEN virtual machines
· Experience in troubleshooting Microsoft SQL clusters
· Experience in troubleshooting IIS webservers
· Handing of server crashes ( BSOD ) and server recovery
· Tuning of Windows operating system templates based on server roles
· Experience in Windows 2008 R2 server migrations to Windows server 2012
· Creation of Windows server templates for different virtualization platforms ( VMware / XEN Experience in remote command based tools like PSTOOLS
· Experience in performing data migration using RSYNC
· Experience in Securing/Hardening Windows Servers
· In-depth knowledge of TCP/IP network
· Experience in handling NFS client / NFS shares in Windows server
· Good understanding of working with Vendors
· Experience in introducing industry best practices in server deployments.
· Experience in root cause analysis
· Good hands-on on Basic / Dynamic disk configurations
· Experience in managing Linux based member servers in an Active Directory domain
· Windows server memory dump analysis skills
· Experience in installing and configuring Windows server automated installation tools for physical servers
· Ability to work in rotation on call duties
· EMC/HITACHI storage configuration skills on Windows servers and should have good understanding on MPIO software from different vendors
· Experience in Implementing / Supporting Microsoft clusters with ISCSI disks on XEN virtualization
· VERITAS / EMC networker backup configuration knowledge on windows servers
· Experience in supporting third-party applications on windows servers such as SFTP solutions like Globalscapes EFT Server, or capable of learning very quickly.
· Experience with Windows OS performance monitoring.
· Experience in Virtualization platform like VMware ESX or Citrix Xen
· Excellent written and verbal communication skills required
· Excellent customer service skills required
Desired:
· Microsoft Certified Systems Engineer (MCSE), Microsoft Certified IT Professional