Director, Software Validation & Compliance (CSA/CSV) (Lake Forest)
STAAR Surgical
STAAR Surgical in Lake Forest is seeking a Director of Software Validation to lead software validation efforts across various platforms. The role involves managing teams, ensuring compliance with FDA regulations, and improving validation practices. Candidates should have extensive experience in software validation and a strong background in medical devices.
This leadership position requires a bachelor's degree in a related field and at least 10 years in software validation, with an emphasis on compliance and risk assessment methodologies.
#J-18808-Ljbffr- ...Edwards Lifesciences is seeking a Director to lead the Software Systems, Process, and Delivery team. This role drives agile execution, orchestrates releases, and ensures compliance across regulated software products in Irvine, California. The ideal candidate will have...SuggestedFull time
$159k - $226k
...Platforms organization designs and builds the software and data products that clinicians and patients depend on. As a Director, you lead the Software Systems, Process, and... ...(design freeze, verification-complete, validation-complete), risk assessments, and post-release...SuggestedFull timeWork experience placementRelocation- ...metrics to measure the SLA / requirements compliance Define, adopt and create required... ...required) Conduct pilot run/review to validate the assets, artefacts as feasible Track... ...maintainability of design Use knowledge of Software Development Process Tools & Techniques to...Suggested
- JOB SUMMARY Performs tests in strict compliance independently, guides other testers and assists test leads for the following: Construct test scenarios based on customer user stories or requirements Construct systematic test cases from scenarios for applications based...Suggested
$179.2k - $322.5k
...Leadership: Define and execute the embedded software engineering vision, roadmap, and... ...excellence, and collaboration. Regulatory Compliance & Quality: Ensure compliance with... ...4971, and FDA software development and validation requirements. Occasional travel to vendors...SuggestedWork at office$160k - $190k
...Job Description Job Description Director of Information Technology Quantum Fuel Systems / Reports to: Chief Executive Officer (CEO) Location: Lake Forest, CA (onsite at company headquarters) Employment type: Full-time FLSA: Exempt Pay Range: $16...Full timeContract workTemporary workWork at officeLocal areaRemote workFlexible hours- ...Administration to hire our Head of R&D. This software expert will be a player-coach, shaping... ...standards for safety, reliability, compliance, and security as we grow. This role... ...and architecture through verification, validation, and commercialization Establish and...Full time
- ...Type Full-time Description The Director of Software Engineering reports to Director of... ...Engineering and Software Verification & Validation organizations. This role serves as... ...cybersecurity risk management, and regulatory compliance. Ability to lead software...Full timeFor contractors
- ...Principal Software Architect Define how developers build AI on next-generation hardware At BrainChip, we’re building a new class of AI. Our neuromorphic processors are designed to process data the way the brain does, enabling ultra-efficient, real-time intelligence...Full time
- ...metadata population for hubs, links, and satellites. Implement validation rules, unit tests, and data quality frameworks to enforce... ...integration patterns (e.g., event driven architectures, Delta Lake) and propose pilots for adoption. Here is what we are seeking...Local areaRelocation
$179.2k - $322.5k
BD is looking for a Director of Embedded Software Development in Irvine, CA. This senior leadership role involves defining the embedded software... ...strategy, managing engineering teams, and ensuring regulatory compliance for medical devices. The ideal candidate will have...Full timeWork at office$159k - $226k
...Edwards Lifesciences Belgium in Irvine, CA, is seeking a Director to lead the Software Systems, Process, and Delivery sub-function of the IHFM AI, Product and Platforms organization. The successful candidate will own the architecture, documentation, and delivery of regulated...Full time- ...BD Mexico is seeking a Senior Manager of Embedded Software Engineering in Irvine, California. This role requires a strategic leader... ...medical devices. You'll manage and develop teams, ensure regulatory compliance, and collaborate with cross-functional teams to optimize...Full timeWork at office
$110k - $140k
...RESTful services and event-based integration patterns to support application interoperability. • Implement data transformation, validation, and routing logic across integration flows. • Support batch and streaming data processing requirements. • Design and...- ...foundations that support both day-to-day operations and long-term compliance readiness. As Head of IT and Cybersecurity, you will take... ...at companies that design and build their own hardware and software products, along with a track record of helping scale IT and cybersecurity...
$201.09k - $277k
...and nurture the experiences under the PlayStation brand, a name synonymous with entertainment excellence and creativity. Manager, Software Engineering Aliso Viejo, CA Role Overview Sony Interactive Entertainment LLC seeks a Manager, Software Engineering in Aliso Viejo,...Full timeRemote workWork from home- ...position is accountable for budgeting, planning and monitoring budget variances, etc. Ensures standards of unit operations are in compliance with all state and federal healthcare regulatory agencies ACDIS & AHIMA guidelines for compliant query, as well as hospital...Permanent employmentFull time
- ...staff, project managers, and department directors on assigned projects and lead project coordination... ...and project documentation in full compliance with client requirements and review... ...Architecture, or related field, plus either a valid California PE license and/or CCM....Contract workTemporary workFor contractorsWork at officeLocal areaImmediate startFlexible hours
- ...Terran Orbital is seeking a Principal Flight Software Engineer, Spacecraft to join our team in Irvine, CA. You will design and lead high-level software architecture for nano-satellite payloads, develop fault-tolerant embedded software, and collaborate with engineers across...Full time
$70k - $300k
...world environments where tight integration between hardware and software is critical. We’re looking for an Embedded Systems Engineer... ..., you will contribute to the architecture, configuration, and validation of the compute systems that serve as the backbone for our robotic...Permanent employmentWork at officeFlexible hours$265k - $300k
...strategy, risk posture, incident response readiness, and regulatory compliance, including the controls and certifications needed to pursue... ...investment, and advise executive leadership and the Board of Directors on technology strategy, enterprise and cybersecurity risk, and...Full timeWork at officeMonday to FridayFlexible hours- ...Job Description The Director of Engineering will lead a team of software engineers delivering high‑quality web and mobile applications. This leader will oversee execution across one Agile team, drive technical delivery, partner closely with Product, and ensure scalable...
- Sony Playstation is seeking a Manager of Software Engineering in Aliso Viejo, CA. The role involves managing software projects related to distributed systems and game virtualization. Candidates should possess a Bachelor’s degree in Engineering or a related field, along...Full timeRemote work
$201.09k - $277k
Sony Interactive Entertainment, located in Aliso Viejo, CA, is looking for a Manager, Software Engineering. The successful candidate will oversee distributed systems and game virtualization software projects, ensuring effective management of stakeholders and risks. This...Full timeRemote work$134.55k - $205.56k
...degree from an ABET-accredited engineering program. ~12 years of transmission design experience. ~ Proficiency with PLS-CADD software. ~ Experience must include preparation of scopes of work, development of conceptual designs, determination of design basis, the...Hourly payWork at officeLocal areaFlexible hours3 days per week- ...seeking a Benefits Analyst for the Service Center Total Rewards Team in San Juan Capistrano, CA. This role focuses on 401(k) data compliance, leave benefits, HRIS integrations, and premium reconciliations, requiring system fluency, UAT excellence, and a commitment to...
- ...simulation, and performance analysis using tools such as Zemax, Code V, FRED, or similar optical analysis software. # Develop and execute optical test plans to validate system performance at component, subsystem, and payload levels. # Design and implement optical test...
- ...Diality Inc. in Irvine, CA, seeks a Director of Software Engineering to lead software development and verification activities for medical... ...devices, ensuring design controls, cybersecurity, and regulatory compliance across products. You will shape strategy, build high‑...Full time
- ...(LRUs) used on fighters, helicopters, and UASs. You and your team of electrical, firmware, software, and mechanical engineers will design, develop, integrate, test, and validate, state-of-the-art products, while maintaining on-time and on-budget performance. You will propose...Work at officeWork from home
$120k - $150k
...responsible for planning, coordinating, and delivering complex software initiatives across the full software development lifecycle.... ...Delivery Readiness • Facilitate requirements discovery and validation activities in partnership with business stakeholders and product...Work at officeRemote work
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