Information Technology Jobs in Hayward

Who We Are:

17A is a new type of management consulting firm. We come from places like McKinsey, Palantir, JP Morgan Philanthropies, and venture-backed Healthcare startups. We share a common goal: improving the quality of government and social services. 17A believes that trust in government is something to be continuously built and earned, through strong service delivery.

We have a dynamic core team, and partner with Consultants, known internally as Project-Based Team Members, to bring the best combination of expertise to what we do. Our team has varied skills from a range of industries and experiences, including management consulting, technology and analytics, and public service. If you've spent the early part of your career in consulting or a fast-paced analytical environment and you're ready to apply those skills to something with direct civic impact, 17A is for you.

The Opportunity:

17A is supporting a large Bay Area county agency on a technology and digital services transformation effort. This is a fully embedded, on-site role — not parachuting in. You'll work inside the agency's digital innovation team, sitting alongside Deputy-level leadership to help the county deliver on its mission to make government more human, more responsive, and more digital. This position is a contract role with the potential to convert to full-time after a few months.

This agency has taken a distinctive approach to transformation: rather than buying expensive new systems and hoping for the best, it's doing the hard, human-centered work of dismantling bureaucracy, redesigning how services are delivered, and building a digital culture from the inside. A core initiative — which brings departments through rapid, structured sprints to identify and address service delivery friction — will be a major focus of this role.

This is a chief-of-staff style position for a sharp, early-career operator ready to take on real ownership. You'll help senior leaders turn strategy into action — managing complex initiatives across departments, facilitating working sessions, and communicating progress clearly to executive and operational audiences.

What You'll Do

• Serve in a chief-of-staff capacity to Deputy-level leaders within the innovation team, helping translate priorities into structured plans and concrete next steps
• Support coordination and execution of digital transformation sprints, including logistics, stakeholder engagement, documentation, and follow-through on recommendations
• Facilitate working sessions with department staff and senior leaders to map current-state processes, identify friction points, and co-design improvements
• Lead and coordinate cross-functional workstreams, tracking progress, surfacing blockers, and keeping stakeholders aligned across a large, multi-department organization
• Prepare executive-level communications including briefings, memos, presentations, and decision documents for senior agency leadership
• Conduct rapid research and analysis to support emerging decisions and evolving priorities
• Help build the internal documentation, playbooks, and operational systems the innovation team needs to scale its impact countywide
• Operate as a collaborative, low-ego team member who is genuinely embedded in the agency's culture and mission

Who You Are

You're 1–2 years into your career and you're looking for a role where you can do meaningful work and see the results directly. You might be a current or former:

• Business Analyst or Associate at a management consulting firm
• Fellow or analyst at a public sector-focused organization (e.g., a government innovation lab, a civic tech organization, or a public agency)
• Analyst in a fast-paced, mission-driven environment where you built strong project management and communication muscles

The Skillset:

You'll thrive in this role if you:

• Are energized by the mission — you genuinely care about improving how government works and the people it serves
• Are comfortable operating with ambiguity and building structure where there isn't any yet
• Have strong project management instincts and can keep multiple workstreams moving simultaneously
• Can communicate clearly and credibly with both frontline staff and senior leaders
• Understand that real transformation requires engineering culture, not just deploying technology
• Are ready to be embedded — not just advisory — and want to see the direct impact of your work
• Are based in or willing to relocate to the Bay Area

Bonus if you have:

• Familiarity with local or county government operations
• Experience with digital services, human-centered design, or service delivery improvement
• Prior exposure to process redesign, organizational change, or operational improvement
• Interest in civic technology and the future of public service delivery

Location:

This position is based out of San Francisco, California and you must reside within the area. If you are interested in remote-only opportunities, please consider joining our Network for future roles.

Compensation:

Due to the nature of our business and the clients that we partner with, compensation for this position (and all of our opportunities) depends on the skillset, tenure, and experience that you possess. This specific position has a range of 90,000- 110,000 annually. Depending on the type of work you do with us, you may be eligible to receive medical benefits and other perks.

Accommodation Statement:

Improving public service delivery requires a team with diverse backgrounds and perspectives. We are an equal opportunity employer committed to diversity and inclusion. We prohibit discrimination and harassment of any kind based race, color, creed, religion, national origin, sex, gender identity, sexual orientation, disability, age, marital status, familial status, pregnancy or pregnancy-related conditions, domestic violence victim status, prior arrest or conviction record, military status, predisposing genetic characteristics, membership or activity in a local human rights commission, or status with regard to public assistance.

We encourage and welcome applicants who identify with groups traditionally underrepresented in government to apply.

Please contact , if you would like to request reasonable accommodation during the application or interview process.

Not interested in this specific opportunity but want to make an impact with the work you do? Join our Network for future consulting opportunities within the public service sector!

Senior/Staff Site Reliability Engineer

Location: Fremont Area (hybrid)

Type: Full-time

Reports To: Head of Software

About the Company:

Work with a venture-funded startup led by experienced entrepreneurs with a track record of building successful healthcare technology companies. Our mission is to transform healthcare delivery through Physical AI-combining advanced AI intelligence with next-generation robotics.

What Sets Us Apart:

• Proven Leadership: Founded by serial entrepreneurs with previous 9-figure exits.
• Strong Funding: Well-capitalized with backing from top-tier investors.
• Clear Market Need: Tackling validated, high-impact problems in healthcare delivery.
• Technical Moat: Building proprietary technology that is extremely difficult to replicate.
• Stealth Advantage: Perfecting our technology in stealth mode before broader market entry.

This is a foundational hire. You own the infrastructure that a pharmacy robot fleet runs on — and you set the standard for how infrastructure is built. Engineers write application code; you make sure it deploys reliably, scales correctly, stays secure, and is observable in production.

You don't write dispense logic. You own the platform it runs on: Terraform, CI/CD, deployment automation, security scanning, observability, certificate management, and the production environment that must pass a mandated penetration test. You write code to solve infrastructure problems, not just configure tools.

• 3+ years Terraform / IaC — Production modules, state management, multi- environment promotion.
• AWS deep — VPC, ECS, RDS, IAM, KMS, SQS, CloudWatch. You understand the security model.
• CI/CD — GitHub Actions or equivalent. Pipeline-as-code, caching, deployment gates.
• Docker — Multi-stage builds, image optimization, production deployment.
• Linux — System administration, troubleshooting, performance analysis

You must be a US citizen or Green card holder to be applicable for this role.

If interested please reach out to to .

Who We Are:

17A is a new type of management consulting firm. We come from places like McKinsey, Palantir, JP Morgan Philanthropies, and venture-backed Healthcare startups. We share a common goal: improving the quality of government and social services. 17A believes that trust in government is something to be continuously built and earned, through strong service delivery.

We have a dynamic core team, and partner with Consultants, known internally as Project-Based Team Members, to bring the best combination of expertise to what we do. Our team has varied skills from a range of industries and experiences, including management consulting, technology and analytics, and public service. If you've spent the early part of your career in consulting or a fast-paced analytical environment and you're ready to apply those skills to something with direct civic impact, 17A is for you.

The Opportunity:

17A is supporting a large Bay Area county agency on a technology and digital services transformation effort. This is a fully embedded, on-site role — not parachuting in. You'll work inside the agency's innovation team, sitting alongside Deputy-level leadership to help the county deliver on its mission to make government more human, more responsive, and more digital. This position is a contract role with the potential to convert to full-time after a few months.

This agency has taken a distinctive approach to transformation: rather than buying expensive new systems and hoping for the best, it's doing the hard, human-centered work of dismantling bureaucracy, redesigning how services are delivered, and building a digital culture from the inside. A core initiative — which brings departments through rapid, structured sprints to identify and address service delivery friction — will be a major focus of this role.

This is a chief-of-staff style position for a sharp, early-career operator ready to take on real ownership. You'll help senior leaders turn strategy into action — managing complex initiatives across departments, facilitating working sessions, and communicating progress clearly to executive and operational audiences.

What You'll Do

• Serve in a chief-of-staff capacity to Deputy-level leaders within the innovation team, helping translate priorities into structured plans and concrete next steps
• Support coordination and execution of digital transformation sprints, including logistics, stakeholder engagement, documentation, and follow-through on recommendations
• Facilitate working sessions with department staff and senior leaders to map current-state processes, identify friction points, and co-design improvements
• Lead and coordinate cross-functional workstreams, tracking progress, surfacing blockers, and keeping stakeholders aligned across a large, multi-department organization
• Prepare executive-level communications including briefings, memos, presentations, and decision documents for senior agency leadership
• Conduct rapid research and analysis to support emerging decisions and evolving priorities
• Help build the internal documentation, playbooks, and operational systems the innovation team needs to scale its impact countywide
• Operate as a collaborative, low-ego team member who is genuinely embedded in the agency's culture and mission

Who You Are

You're 1–2 years into your career and you're looking for a role where you can do meaningful work and see the results directly. You might be a current or former:

• Business Analyst or Associate at a management consulting firm
• Fellow or analyst at a public sector-focused organization (e.g., a government innovation lab, a civic tech organization, or a public agency)
• Analyst in a fast-paced, mission-driven environment where you built strong project management and communication muscles

The Skillset:

You'll thrive in this role if you:

• Are energized by the mission — you genuinely care about improving how government works and the people it serves
• Are comfortable operating with ambiguity and building structure where there isn't any yet
• Have strong project management instincts and can keep multiple workstreams moving simultaneously
• Can communicate clearly and credibly with both frontline staff and senior leaders
• Understand that real transformation requires engineering culture, not just deploying technology
• Are ready to be embedded — not just advisory — and want to see the direct impact of your work
• Are based in or willing to relocate to the Bay Area

Bonus if you have:

• Familiarity with local or county government operations
• Experience with digital services, human-centered design, or service delivery improvement
• Prior exposure to process redesign, organizational change, or operational improvement
• Interest in civic technology and the future of public service delivery

Location:

This position is based out of San Francisco California and you must reside within the area. If you are interested in remote-only opportunities, please consider joining our Network for future roles.

Compensation:

Due to the nature of our business and the clients that we partner with, compensation for this position (and all of our opportunities) depends on the skillset, tenure, and experience that you possess. These specific positions have a range of 90,000- 120,000 annually. Depending on the type of work you do with us, you may be eligible to receive medical benefits and other perks.

Accommodation Statement:

Improving public service delivery requires a team with diverse backgrounds and perspectives. We are an equal opportunity employer committed to diversity and inclusion. We prohibit discrimination and harassment of any kind based race, color, creed, religion, national origin, sex, gender identity, sexual orientation, disability, age, marital status, familial status, pregnancy or pregnancy-related conditions, domestic violence victim status, prior arrest or conviction record, military status, predisposing genetic characteristics, membership or activity in a local human rights commission, or status with regard to public assistance.

We encourage and welcome applicants who identify with groups traditionally underrepresented in government to apply.

Please contact , if you would like to request reasonable accommodation during the application or interview process.

Not interested in this specific opportunity but want to make an impact with the work you do? Join our Network for future consulting opportunities within the public service sector!

Key Responsibilities

Business & Revenue Growth

• Own P&L and revenue targets for the Hi-Tech vertical.
• Drive new business (hunting) with global technology, semiconductor, product engineering, and platform companies.
• Expand existing accounts through farming and cross-selling the companies capabilities.
• Identify and build pipeline for large transformation and ER&D deals.

Client & Stakeholder Management

• Act as senior client partner for strategic Hi-Tech accounts.
• Build CXO-level relationships across engineering, product, and digital leadership.
• Position the company as a strategic engineering and technology transformation partner.

Strategic Leadership

• Define go-to-market strategy for the Hi-Tech segment.
• Work closely with delivery, solutioning, and practice teams to create differentiated offerings.
• Drive market expansion in areas like Product Engineering, Digital Engineering, Cloud, AI, Embedded, and Platforms.

Deal & Governance

• Lead large deal pursuits, RFP responses, and commercial negotiations.
• Ensure governance, margin management, and account profitability.
• Track market trends, competitor landscape, and emerging technology opportunities.

Desired Candidate Profile

• 15+ years of experience in Hi-Tech / Product Engineering / Engineering Services.
• Proven track record of hunting + farming with global technology or semiconductor clients.
• Experience managing large strategic accounts and multi-million-dollar portfolios.
• Strong exposure to ER&D, Digital Engineering, Software Platforms, Embedded, Cloud, or AI.
• Demonstrated CXO engagement and large deal closure capability.

Senior/Staff Software Engineer

Location: Fremont Area (hybrid)

Type: Full-time

Reports To: Head of Software

About the Company:

Work with a venture-funded startup led by experienced entrepreneurs with a track record of building successful healthcare technology companies. Our mission is to transform healthcare delivery through Physical AI-combining advanced AI intelligence with next-generation robotics.

What Sets Us Apart:

• Proven Leadership: Founded by serial entrepreneurs with previous 9-figure exits.
• Strong Funding: Well-capitalized with backing from top-tier investors.
• Clear Market Need: Tackling validated, high-impact problems in healthcare delivery.
• Technical Moat: Building proprietary technology that is extremely difficult to replicate.
• Stealth Advantage: Perfecting our technology in stealth mode before broader market entry.

This is a foundational hire. You own the cloud services that power the dispense pipeline — and you set the engineering standard for how they're built. Prescription lifecycle, inventory management, fleet coordination, safety gates. You design the systems, make the technical calls, and establish the patterns that the team builds on. As we grow, the practices you put in place become the way we work. You'll collaborate closely with a small, senior engineering team and take full ownership of your domain.

Must-Have

• Distributed systems expertise — You've designed and operated services where correctness under concurrency, partial failure, and network partitions actually matters. Not just read about it.
• PostgreSQL — Schema design, migrations, performance tuning, transactions. Not just an ORM user.
• API and system design — You've made technical decisions that shaped how other engineers build. You've owned interfaces that other systems depend on.
• Message queue patterns — At-least-once delivery, dead letter queues, backpressure, idempotency. SQS, Kafka, or similar.
• Safety-critical mindset — You design the failure path first. The happy path is just "recovery wasn't needed."
• Rust — You've shipped Rust to production. async/Tokio, error handling patterns, type-driven design.
• Technical leadership — You've raised the bar on a team. Through code review, architecture decisions, mentorship, or establishing conventions that stuck. You don't need a title to lead.

Please apply if you are intersted!

Senior Andrologist (California CLS Required) – Fertility Clinic

Job Summary

The Senior Andrologist is responsible for performing and overseeing advanced andrology and reproductive laboratory procedures within a fertility clinic setting. This role supports male fertility evaluation, endocrine testing, and assisted reproductive technologies (ART) by performing semen analyses, sperm preparation, and hormone testing while ensuring compliance with California laboratory regulations.

The Senior Andrologist also supervises andrology laboratory operations, maintains quality control standards, and collaborates closely with reproductive endocrinologists, embryologists, and clinical staff to support patient care.

Key Responsibilities

Andrology Laboratory Testing

• Perform diagnostic semen analysis according to WHO guidelines and laboratory protocols.
• Conduct advanced sperm function testing including:
• Morphology assessment
• Motility and vitality analysis
• Sperm concentration and total motile count
• DNA fragmentation testing when applicable
• Prepare sperm samples for assisted reproductive technologies (ART) including:
• Intrauterine Insemination (IUI)
• In Vitro Fertilization (IVF)
• Intracytoplasmic Sperm Injection (ICSI)
• Process surgical sperm retrieval samples including TESA, PESA, and micro-TESE.

Endocrinology & Hormone Testing

• Perform and oversee reproductive endocrinology testing related to fertility diagnostics.
• Operate immunoassay analyzers including Roche Cobas e411 for hormone testing (e.g., FSH, LH, Estradiol, Progesterone, AMH, Testosterone, hCG, Prolactin).
• Perform linearity verification and calibration verification (CALVER) as required by laboratory validation protocols.
• Conduct and document CAP Proficiency Testing (PT) in compliance with CLIA and CDPH regulations.
• Troubleshoot analyzer performance issues and perform corrective actions as needed.
• Perform routine and scheduled instrument maintenance, calibration checks, and functional verification of the analyzer.
• Monitor assay performance and maintain quality documentation for regulatory inspections.

Sperm Banking & Cryopreservation

• Perform sperm cryopreservation and thawing procedures for fertility preservation and donor banking.
• Maintain specimen tracking and chain-of-custody documentation.
• Ensure compliance with CAP, CLIA, FDA tissue regulations, and California Department of Public Health (CDPH) requirements.

Laboratory Operations & Quality Management

• Maintain compliance with California Clinical Laboratory licensing regulations.
• Implement and maintain laboratory quality assurance and quality control programs.
• Perform method validation, verification, and instrument performance checks.
• Assist with preparation for CAP, CLIA, and CDPH laboratory inspections.
• Maintain laboratory documentation, standard operating procedures (SOPs), and regulatory records.

Leadership & Training

• Supervise and train andrology and laboratory technologists.
• Ensure staff competency and continuing education compliance.
• Assist in development and updates of laboratory SOPs.
• Participate in laboratory audits and regulatory readiness activities.

Clinical Collaboration

• Work closely with reproductive endocrinologists, urologists, embryologists, and nursing staff.
• Provide consultation regarding male fertility testing, sperm preparation methods, and endocrine laboratory results.
• Participate in multidisciplinary patient case discussions and treatment planning.

Required Qualifications

Education

• Bachelor’s degree or higher in Clinical Laboratory Science, Biology, Biochemistry, or related field.

Licensure

• Active California Clinical Laboratory Scientist (CLS) License issued by the California Department of Public Health (CDPH).

Experience

• 5+ years of laboratory experience, preferably in fertility, andrology, or reproductive medicine laboratories.
• Experience performing semen analysis, sperm preparation for ART, and hormone immunoassay testing.
• Experience operating and troubleshooting Roche Cobas e411 or similar immunoassay analyzers.

Preferred Qualifications

• Experience working in IVF or assisted reproductive technology laboratories.
• Familiarity with CAP accreditation standards, CLIA requirements, and CDPH regulations.
• Experience with instrument validation, proficiency testing programs, and regulatory inspections.

Key Skills

• Advanced knowledge of male fertility diagnostics and semen analysis techniques
• Expertise in ART sperm preparation methods
• Strong knowledge of endocrinology testing and immunoassay instrumentation
• Ability to troubleshoot laboratory instruments and perform technical maintenance
• Thorough understanding of CAP, CLIA, and CDPH regulatory compliance
• Strong attention to detail and laboratory documentation practices
• Effective leadership and communication skills

Work Environment

• Fertility clinic laboratory setting
• Handling of human reproductive specimens and biological materials
• May require early morning, weekend, or on-call work depending on clinical schedules

Job Description

Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing solutions, delivering superior quality and support to Original Equipment Manufacturers (OEMs) primarily in the communications networks, defense and aerospace, industrial and semiconductor systems, medical, multimedia, computing and storage, automotive and clean technology sectors. Sanmina Corporation has facilities strategically located in key regions throughout the world.

Specializing in precision machining and metal fabrication, our Sanmina Newark, California facility has 15 years experience in both precision and large format solutions for industrial, semiconductor, clean technology and oil & gas markets. We provide comprehensive engineering and test capabilities: from in-house and hydrostatic leak-testing of medium and large format vacuum chambers to machining of precision stainless steel mechanisms. We have the capacity to machine components up to 3 meters. Our metal fabrication services include grinding, vacuum welding, heat treating, plating and anodizing. We can process many advanced materials, including aluminum, stainless steel, plastics, ferrous-nonferrous and other exotic alloys.

Job Responsibilities

• Working independently, responsible for the activities and monitoring of the supply chain involved in the savings programs.
• Wearing MRP and/or manual requirements, analyzes the demand to determine the needs of the site, releasing RFQ's for price and availability.
• Responsible for the management of all SB program requests, metrics and reports, meetings with suppliers (SBR's) 3 times
• per year, customer service and availability to travel
• Working independently, coordinates purchasing activities and processes purchase reqs in a timely manner.
• Using MRP and/or manual reqs, analyzes demand to determine need, sends out RFQ's for price and availability.
• Monitors supplier delivery.
• Negotiates price/volume/delivery dates.
• Processes RMA's.
• Expedites and reschedules as necessary to meet production requirements.
• Responsible for resolving AP/AR issues through analysis and investigation.
• May research alternative suppliers for obsolete or long lead time parts.
• Senior Buyers may manage implementation of engineering changes, interpretation of procurement policies, process improvement projects, contract negotiation and approval of PPV's.

Education: Engineering, Administration or Commerce

Experience:

2-8 years’ experience in Purchasing or Supply Chain.

3 years experience buying metals for a machine shop

Knowledge:

Management of Oracle, M3K, Knowledge of key metrics in the purchasing area, negotiation with suppliers, Flexibility Programs (VMI, VCI,830, etc..), Knowledge of MRP and production processes

Skills / Competencies:

Good knowledge and understanding of the supply chain, the negotiation process and cost analysis.

Personality traits: Responsible, committed, proactive, analytical, work under pressure.

This is an ITAR facility and applicant must be a US Citizen or a lawful permanent resident.

Sanmina is an Equal Opportunity Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Sr Course Developer/Instructional Designer - Semiconductor required

On-site Flex: 3 days in office/2 remote in Fremont, CA (there is no relocation available .Local candidates only) - DONT APPLY IF YOU ARE NOT LOCAL.

This position is task-based course development/training and looking for background in performance-based equipment training.

Technical Docs/Procedures will be provided to the candidate to then translate into course work/curricula for the technicians.

Key Responsibilities:

• Design and develop comprehensive courses on various semiconductor industry topics, including semiconductor manufacturing, process technology, device physics, and emerging trends.
• Collaborate with subject matter experts to gather and verify course content.
• Utilize instructional design principles to create engaging and interactive training modules, including e-learning, instructor-led training, and blended learning formats.
• Develop assessment tools to evaluate the effectiveness of training programs and learner comprehension.
• Continuously update and improve course content to reflect the latest industry advancements and best practices.
• Provide guidance and support to instructors and facilitators on course delivery and implementation.
• Conduct pilot testing and gather feedback to refine course materials.
• Stay current with trends and advancements in semiconductor technology and educational methodologies.

Additional Responsibilities and Expectations:

• Translate employee technical training and development needs into engaging courses.
• Select appropriate instructional methods, define time frames, and prepare training materials in physical and digital formats.
• Conduct skills gap analyses.
• Design detailed educational curricula, including dates, topics, and hours required per course.
• Create engaging training course content (videos, quizzes, activities).
• Set learning objectives for each course and determine evaluation criteria.
• Organize physical and digital resources for instructors and trainees.
• Provide training manuals and follow up with trainees and instructors after each course to collect feedback.
• Research and recommend modern educational methods (e.g., gamification).
• Ensure on-time delivery of projects and manage tasks/projects effectively.
• Design and create hardware certifications.

Qualifications:

• Bachelor's degree preferred in Electrical Engineering, Semiconductor Technology, Education, or a related field.
• Proven experience in instructional design and course development, preferably within the semiconductor industry.
• Strong understanding of semiconductor processes, technologies, and industry standards, with a technical focus.
• Proficiency with e-learning authoring tools (e.g., Articulate 360 - STORYLINE is a must have, Adobe Captivate) and learning management systems (LMS).
• Excellent written and verbal communication skills.
• Ability to translate complex technical concepts into clear and concise learning materials.
• Strong project management skills with the ability to handle multiple projects simultaneously.
• Detail-oriented with a commitment to producing high-quality educational content.

Preferred Skills:

• Experience with multimedia production and editing tools.
• 5+ years in training and/or course development.
• Familiarity with instructional design models such as ADDIE, SAM, or PBET.
• Previous experience in a semiconductor manufacturing environment.

Mandatory Skills:

• Proficiency with Microsoft PPT, Excel, and Word. (PowerPoint and excel should be highly proficiency).
• Proven experience in instructional design and course development, preferably within the semiconductor industry.
• Effective communication and fluent Technical English.
• Ability to write clear instructional copy.

Desirable Skills:

• Photo editing, animation creation, Visio, video editing.
• Experience with Learning Management Software (LMS) (e.g., Cornerstone, SuccessFactors).
• Presentation skills, Articulate Storyline, audio editing.
• Adobe FrameMaker, storyboard creation.

Vice President, Regulatory Affairs & Quality

San Francisco Bay Area (Hybrid)

We are partnering with a venture-backed, early-stage medical device company in the San Francisco Bay Area developing a next-generation software-driven surgical platform leveraging AI to transform procedural care.

With strong early momentum and a clear path toward clinical and regulatory milestones, the team is looking to bring on a Vice President of Regulatory Affairs & Quality to build and lead the entire RA/QA function from the ground up.

The Opportunity

This is a true foundational leadership role, reporting directly to the executive team, where you will:

• Own and define the regulatory and quality strategy for a novel AI-enabled medical device platform
• Lead FDA interactions and act as the primary point of contact with the agency
• Drive 510(k) submissions from scratch (including strategy, authoring, and execution)
• Build and scale a fit-for-purpose Quality Management System (QMS) aligned with FDA and ISO 13485
• Partner closely with R&D, Software, Clinical, and Executive leadership to align regulatory pathways with product development
• Prepare the organization for key inflection points including submissions, audits, and early commercialization

What We’re Looking For

• 10–15+ years of experience in Regulatory Affairs / Quality within medical devices
• Proven track record leading 510(k) submissions from concept through clearance
• Strong experience with software-driven / SaMD / AI-enabled technologies
• Deep understanding of FDA regulations, design controls, and QMS implementation
• Prior experience in an early-stage or startup environment (highly preferred)
• Demonstrated ability to operate as a hands-on leader and strategic partner

Why This Role

• Opportunity to own and build the RA/QA function from zero
• Work directly with an experienced leadership team and investors
• Be part of a company tackling a high-impact clinical problem with differentiated technology
• Significant influence on regulatory strategy, product direction, and company trajectory