Engineering Structures Jobs in Emerald Hills, CA

Data Scientist Everfit | Hybrid, San Francisco Bay Area

About Everfit

Everfit is a fitness technology company building an AI-powered coaching platform that serves 280,000+ coaches and millions of training clients globally. We're transforming how fitness professionals deliver personalized training and nutrition guidance to their clients through intelligent automation and data-driven insights.

About the Role

We're looking for a senior data scientist who is passionate about fitness and energized by turning data into actionable insights that help coaches and their clients succeed. You'll play a critical role in understanding user behavior, product performance, and business metrics to inform strategic decisions as we scale our platform.

What You'll Do

Product Analytics & User Insights

• Define and track key product metrics (activation, engagement, retention, churn) to measure product health and success.
• Conduct cohort, funnel, and retention analyses to uncover behavioral insights and inform feature prioritization.
• Identify opportunities to improve onboarding, engagement, and coach–client interactions.

Experimentation & A/B Testing

• Own the experimentation framework and guide teams through hypothesis design, sample sizing, execution, and interpretation.

Strategic Impact & Roadmapping

• Collaborate with leadership to translate data insights into roadmap priorities and measurable business outcomes.
• Build predictive models and scenario analyses to support forecasting, pricing, and product investment decisions.
• Establish best practices in data instrumentation, dashboarding, and self-serve analytics across teams.

Technical Foundations

• Partner with data engineering to improve pipelines and instrumentation.
• Leverage tools such as SQL, Python/R, data visualization platforms, and experimentation platforms.

Marketing Analytics & Optimization

• Analyze customer acquisition funnels and marketing performance to identify high-impact opportunities for growth and conversion.
• Partner with marketing and growth teams to design and evaluate campaign experiments

What We're Looking For

• 4-6 years of experience in a data analyst or analytics role, preferably at a growth-stage tech company
• Strong proficiency in SQL and experience setting up data pipelines, transforming data, and analyzing large datasets
• Deep experience with creating dashboards and providing analysis on product analytics and data visualization tools (Amplitude, Looker, Tableau, Mode, or similar)
• Understanding of SaaS metrics and cohort analysis
• Experience with translating numerical findings into clear insights for non-technical team members
• Genuine passion for fitness, health, or wellness (we build for coaches so you need to understand their world)

Bonus Points:

• Experience with Python or R for statistical analysis
• Experience in a PLG (Product-Led Growth) environment
• Experience working at a company during a hypergrowth phase
• Background in fitness, health, wellness, or coaching industries

You'll thrive here if you:

• Are naturally curious and love asking "why" until you find the answer
• Are excited by fast-paced, high-growth environments with a passion for building out systems for scaling
• Enjoy collaborating with global teams and making complex topics understandable
• Are comfortable with ambiguity and can structure your own work
• Care deeply about the impact your insights have on real coaches and their clients

Why Join Everfit

• Establish the foundations for Fitness Intelligence and help shape the future of coaching for millions around the world
• Work with autonomy and ownership on high-impact projects
• Join a collaborative, global team with experience from leading tech and fitness companies
• Enjoy competitive salary, equity, and performance bonuses
• Build something meaningful that helps people live better, healthier lives

Everfit is an equal opportunity employer committed to building a diverse and inclusive team. We make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected status.

Ready to dive into data in the fitness intelligence space? We'd love to hear from you.

We’re hiring a Founding Product Manager to help build AI-powered software transforming how logistics operators work.

This is not a feature-factory PM role.

This is a ground-floor opportunity to design and ship a product that turns messy, real-world logistics workflows into simple, trusted, intelligent software.

Who we’re looking for

You’re scrappy, systems-minded, and thrive in ambiguity.

• 3–5+ years shipping B2B SaaS products
• Experience building products from 0→1 (ideally for non-technical users)
• Comfortable operating in highly regulated or operationally complex industries
• Strong product instincts paired with structured thinking
• Bonus: logistics, supply chain, or fintech experience
• Early stage startup experience

You’re excited by turning operational chaos into elegant, intuitive systems.

What you’ll do

• Own end-to-end product execution. from customer discovery and prioritization through delivery and launch
• Map messy, real-world logistics workflows into crisp product experiences
• Work closely with engineering to ship AI features operators trust defining quality bars for accuracy, confidence, and explainability
• Build the product foundation: instrumentation, metrics, release processes, and scalable systems
• Visit customers to deeply understand workflows and pain points
• Partner with GTM to drive adoption, retention, and expansion

This is a true founding PM role. You’ll shape not just features, but the product philosophy and operating system of the company.

Comp

$150K–$200K

0.3–0.8% equity

If you want to build at the intersection of AI and global trade and be the product leader from day one please send in your resume asap

Company Description

Savor is a venture-backed startup pursuing transformational technology to produce highquality, healthy and affordable fats without negative climate impact or cruelty to animals. Our deeply technical company is taking an absolute swing for the fences in the climate fight and are looking for someone who shares our passion for the mission.

Role Description

We are seeking a senior level Product Manager to help drive Savor’s product development, primarily based in San Jose, CA. In this role, you will join our world-class technical team to develop the new class of products we’re bringing to market and have the opportunity to be part of creating and growing our values-first, mission-driven company.  

Responsibilities

• Manage the lifecycle of Savor’s product portfolio by defining new product needs statements, specifications, and ensuring change management for existing products 
• Consolidate and analyze customer feedback to identify key product development opportunities and technology gaps  
• Support the development and execution of Savor’s product roadmap by translating customer insights into actionable internal development initiatives, balancing technology and business needs 
• Develop compelling external-facing technical materials that effectively communicate Savor's product performance advantages to partners  
• Facilitate cross-team coordination on development activities in product stage gate process 

Qualifications/Skills

• Bachelor's degree in Chemistry, Materials Science, Chemical Engineering, or related technical field; advanced degree preferred 
• Minimum of 5-7 years of experience within a hard tech company, preferably in a product management role. Background in specialty chemicals is a plus.  
• In-depth knowledge of the product development lifecycle, including the challenges and opportunities associated with scaling from R&D to commercial production. 
• Excellent documentation and communication skills 
• Data-driven and structured approach to problem solving  

If there are items under the “Qualification/Skills” section that you are working towards or would like to pursue, we still encourage you to apply. Our promise is that a real person will review your application! 

Working Conditions

• Office environment 

Logistics

We offer competitive compensation and benefits. Our current HQ is located in San Jose, CA. This is a hybrid position, requiring 2-3 days per week in office, so you will need to be able to commute to our office or be willing to relocate. Occasional travel (approximately 10-20% annually) may be required for customer meetings, partner site visits, or industry conferences.  

We are an Equal Opportunity Employer - we do not discriminate in hiring, promotions, or any other way on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.  

Contact   with your resume/CV if you are interested in learning more about this opportunity.   

About Us 

Savor is a pioneering food technology company dedicated to transforming the global oils and fats industry. We develop innovative, sustainably produced oils and flavoring systems that serve the food, personal care, and specialty ingredients markets. Our science-led approach and entrepreneurial culture attract partners who share our conviction that better ingredients make a better world. 

Savors commercialization team is a small, highly value-driven, and fast-moving group, working at the intersection of strategy, partnerships, storytelling, and real-world experiences: tastings, chef collaborations, customer launches, and industry events where our product must show up flawlessly. 

We care deeply about how we work, as much as what we build: thoughtful collaboration, high standards, ownership, curiosity, and respect for our products and technology — from science to hospitality. 

The Role 

We’re looking for a highly organized, proactive Commercial Operations & Events Manager to become the operational backbone of our commercialization team. 

You will report directly to our Head of Partnerships and will also work actively with the VP of Commercialization and Brand Manager, helping turn ideas into execution — coordinating events, shipments, communications, and schedules so the team can focus on building relationships and growing the business. This position is primarily centered on events and logistics management (approximately 75%), with the remaining time dedicated to executive support functions. 

This role is ideal for someone who loves making complex things run smoothly and wants meaningful exposure to strategy, partnerships, and startup execution. 

No two weeks look the same: one day coordinating a partner tasting, another organizing sample logistics, preparing materials for an executive meeting, or helping bring a high-profile dinner to life. 

What You’ll Do 

Bring Experiences to Life 

• Coordinate tastings, dinners, demos, and industry events. Note: our more involved tastings will include collaboration with a Culinary / Demo Chef. 
• Manage logistics, timelines, materials, and execution details 
• Help ensure every event reflects our standards for quality and storytelling 
• Lead on-site setup and execution for San Francisco-based events, including the presentation of our food products 

Own Samples & Logistics 

• Coordinate preparation and shipment of customer samples 
• Act as the communication hub between internal teams and external partners regarding samples 
• Track deliveries and maintain inventories of samples and event materials 

Connect Teams & Resources 

• Coordinate across commercialization, marketing, and external creatives (designers, photographers, printers) 
• Prepare simple print and demo materials 
• Maintain organized digital files and shared assets 
• Suggest improvements and build systems for effective work and collaboration & to streamline processes, e.g. using AI tools 
• Coordinate pickups and deliveries tied to food production and events, ensuring smooth logistics across kitchens, partners, and internal teams 
• Drive materials between San Francisco, East Bay, and San Jose when needed 

Keep the Commercial Engine Running 

• Coordinate meetings and follow-ups 
• Support sales operations including customer communications, tracking 
• Maintain organized systems for opportunities, materials, and information 
• Support the commercial leadership with calendar management and scheduling, occasional travel scheduling 

Who Thrives Here 

You might be a great fit if you: 

• Have event management and/or executive assistance experience (5+ years preferred)
• Enjoy both planning and hands-on execution 
• Take pride in details others miss 
• Have a creative eye for all things hospitality 
• Naturally bring structure to fast-moving environments 
• Communicate clearly and follow through reliably 
• Have direct experience in food / hospitality 
• Care about sustainability and mission-driven work 

What We Value 

• Ownership over rigid job boundaries 
• Thoughtfulness and kindness in how we work together 
• Craft and quality in execution 
• Clear communication and reliability 
• Building something meaningful with a small, committed team 

Practical Details 

• Bay Area–based role, preferred around San Francisco, CA 
• Hybrid role: Work is remote most days, with one required weekly in-office collaboration day at our San Jose office. Presence is also required at events and as needed in-office, for example for sample shipments. 
• Driving required between San Francisco, East Bay, and San Jose 
• Occasional evening or event hours, expected 4-5 days per month 
• Ability to transport event materials and product samples 

Logistics 

• Savor offers compensation commensurate with experience, including a base salary of $120k-$150k. Additional benefits include: 
• Equity participation at a meaningful stage in Savor’s growth. 
• Participation in Savor's performance bonus program, currently under development. The program is anticipated to offer a target bonus of 10–15% of base salary, tied to individual and company performance.  
• Health, dental, and vision coverage.   

We are an Equal Opportunity Employer - we do not discriminate in hiring, promotions, or any other way on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.   

Contact with your resume/CV if you are interested in learning more about this opportunity.

• 
  
• Support the setup and launch of the new Process Technologies & Development lab, including workspace organization, equipment installation support, and qualification readiness.
  
• Operate, maintain, and troubleshoot a broad range of primary container and analytical laboratory equipment, including:
  
  • 
    
  • Leak detection systems
    
  • Headspace analyzers
    
  • Optical and particle counting microscopes
    
  • MicroCT scanners
    
  • Automatic filling equipment
    
  • Filtration and mixing tanks
    
  • Balances and related instrumentation
    
  
  
  
• Independently refine and develop laboratory processes and equipment workflows to improve efficiency, robustness, and usability.
  
• Maintain accurate equipment logs, calibration records, and instrument readiness documentation.
  
• Ensure laboratory organization, including consumables tracking, chemical inventory, and compliance with safety, quality, and documentation requirements.
  
• Partner with Facilities, Metrology, EH&S, and cross-functional Process Development teams to support seamless lab operations and timely issue resolution.
  

• 
  
• Apply sound scientific judgment in planning and troubleshooting experimental studies.
  
• Support method development, workflow optimization, and evaluation of new technologies relevant to primary container development and characterization.
  
• Drive continuous improvement in lab workflows, equipment utilization, and operational efficiency.
  
• Maintain a culture of cleanliness, organization, and scientific excellence within the laboratory.
  

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• Bachelor's or Master's degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related technical field.
  
• Hands-on laboratory experience (academic or industry) with strong familiarity in equipment operation and laboratory best practices.
  
• Demonstrated experience designing and executing experiments with strong attention to detail and scientific rigor.
  
• Excellent organizational skills with a proven ability to maintain a clean, structured, and efficient laboratory environment.
  
• Strong communication skills and ability to manage multiple priorities in a fast-paced environment.
  

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• Experience supporting laboratory setup, including equipment installation, qualification, and initial operational readiness.
  
• Familiarity with a broad range of laboratory equipment, including routine operation, troubleshooting, and maintenance.
  
• Experience with studies involving:
  
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  • Container Closure Integrity (CCI)
    
  • Extractables and Leachables
    
  • Device-drug interface evaluations
    
  • Fill-finish operations
    
  
  
  
• Ability to design and refine lab workflows that improve efficiency and usability across teams.
  
• Prior experience working within cross-functional development teams.
  

Job Responsibilities:

• Take full ownership of project delivery from concept through construction, ensuring alignment with Flint’s constructability and BIM standards, client expectations, and financial goals.
• Lead multidisciplinary teams in the coordination of architectural, engineering, and construction processes; provide strategic guidance across all phases of design-build execution.
• Oversee and manage detailed project schedules, deliverables, and budgets; ensure key milestones are met and proactively identify and resolve risks or roadblocks.
• Facilitate and lead high-level project meetings, including design charrettes, owner presentations, technical coordination sessions, and internal strategy meetings; set clear agendas, drive outcomes, and ensure accountability.
• Oversee engagement with school districts, local jurisdictions, city planning departments, and permitting agencies to streamline submittals, revisions, and approvals.
• Provide executive-level oversight of design documentation including contracts, narratives, scopes of work, and change documentation to ensure clarity, alignment, and quality.
• Drive proposal development, fee structuring, and project scoping in close coordination with other architects, estimating, preconstruction, and executive teams.
• Direct and manage BIM execution strategies in collaboration with VDC staff; ensure accurate modeling, clash detection, and seamless transition to construction documentation.
• Ensure all project documentation meets both regulatory and constructability standards; provide quality control oversight and technical reviews as needed.
• Resolve design and construction coordination challenges swiftly and decisively; escalate issues only when necessary and act as the primary point of accountability.
• Provide high-level mentorship and leadership to project architects, designers, and support staff; foster a proactive, solutions-driven culture focused on excellence, growth, and results.

Job Requirements, Qualifications, Characteristics:

• Bachelor’s degree in Architecture.
• Licensed Architect
• 10+ years of architectural project management experience with a strong understanding of design development, construction documentation, drawings and specifications, and coordination in a fast-paced, collaborative environment.
• High proficiency in Revit is required; experience with Bluebeam, Microsoft Excel, and other design and construction-related platforms is strongly preferred.
• Familiar with Adobe Creative suite, Lumion, Enscape, Autodesk construction cloud. Modeling/drafting software such as Sketchup and AutoCAD.
• Proficient is 3D modeling & coordination tools such as ACC and Revizto.
• Having education/ DSA and public project coordination is a must.
• Strong project coordination and communication skills, with proven success managing interdisciplinary teams and fostering collaboration between design, preconstruction, and field teams.
• Commitment to high standards of professionalism, equity, and teamwork; experience engaging with diverse communities is valued. Demonstrated ability to produce accurate and detailed technical drawings and construction documents.
• Must be proactive, self-motivated, and comfortable stepping into hands-on design tasks when needed to support team success.

About Straia

At Straia, we’re building the AI-native intelligence layer for colleges and universities.

Today, colleges run on dozens of disconnected systems, forcing staff to spend hundreds of hours manually reconciling data, compiling reports, and tracking down insights. Straia changes that. We unify institutional data and layer on AI agents that answer questions, generate insights/visualizations, and automate repetitive workflows, transforming how colleges operate.

Over time, Straia will evolve into the core intelligence layer for institutional operations, where every function, from student advising to admissions to budgeting and resource planning, is supported by collaborative AI agents that understand each institution’s unique data landscape.

We recently raised our pre-seed from a16z, Reach Capital, and JFF Ventures, and are now hiring a founding backend engineer to help build the technical backbone of how institutions interact with their data.

The Role

As a Founding Engineer at Straia, you’ll work directly with a small team including directly with our CEO (Ryan), CTO (Alan) and CPO (Nikki) to design, build, and scale the core infrastructure of our platform.

This is a 0 → 1 opportunity to shape not just the product, but the engineering culture, architecture, and trajectory of the company. You’ll ship fast, make key technical decisions, and help define how AI can power the next generation of enterprise data intelligence.

We’re specifically looking for someone who consistently raises the bar. The kind of engineer whose default speed and judgment increase the velocity of everyone around them. If you thrive when expectations are high and the pace is fast, you’ll feel right at home

What You'll Do

• Build the core platform — architect and implement services spanning data ingestion, query orchestration, and agentic AI workflows
• Ship end-to-end features across our React + Node.js + Postgres stack, integrating directly with LLMs like GPT, Gemini, and Claude
• Scale infrastructure on GCP for performance, reliability, and data security
• Collaborate with users (university data teams and administrators) to translate real problems into elegant, powerful solutions
• Lay the foundation for Straia’s engineering culture, best practices, and technical roadmap
• Prototype fast, iterate faster — your work will directly shape how education leaders experience AI in their daily decision-making

Who You Are

• 4–7 years of experience building and shipping full-stack applications, with a strong emphasis on backend systems (Node.js, TypeScript, Postgres).
• Deeply technical, with a track record of building scalable, high-quality software
• Startup-minded — you thrive in ambiguity, love building from scratch, and see constraints as creative fuel
• Mission-driven — excited to improve education through technology that makes institutions smarter, faster, and more equitable
• Collaborative and high-agency — you take initiative, value clear communication, and have the instincts of an owner, not an employee
• AI-curious or experienced — exposure to LLMs, vector databases, or prompt engineering is a plus

Our Stack

• Frontend: React + Vite
• Backend: Node.js + Express, orchestrating data and AI agent workflows
• Data Layer: Postgres + Caching for fast queries
• LLM Integration: GPT, Gemini, Claude via API
• Cloud & Infra: Hosted on GCP

Why Join Straia

• Be one of the first engineers at a venture-backed AI company redefining institutional intelligence in higher ed
• Shape the core architecture and engineering culture from day one
• Work directly with top-tier investors and advisors from a16z, Reach, and JFF Ventures
• Join a small, fast-moving team that works incredibly hard, ships fast, and still makes time for good food, laughs, and adventures — we take our work seriously, but not ourselves
• Build meaningful technology that directly impacts student success and equity across colleges nationwide

What We Offer

• Compensation: $160K–$225K + equity
• Location: San Francisco (in office 4 days a week)
• Benefits: Health (platinum insurance), dental, and vision

**We do not sponsor Visas**

Developer Advocate (DevRel) / Contract, extendable 3-months / Palo Alto, CA

Summary:

As the Developer Advocate for our Agents, you are the bridge between our products and the global engineering community. Your mission is to champion a new era of Agentic DevOps, helping developers move beyond manual pipelines to autonomous, AI-driven software delivery.

You will be the primary voice for our suite of Agents, ensuring that developers can seamlessly integrate AI into their existing SDLC.4

Responsibilities:

• Content Creation: Produce high-signal technical content—tutorials, deep-dive blogs, and \"Agent Recipes\"—that demonstrate how to use Client's Agents to automate security audits, performance benchmarking, and multi-cloud deployments.
• Community Engagement: Actively support the \"Agentic\" community on GitHub, Discord, and Stack Overflow. You will represent Client at industry events, leading workshops on how AI agents reduce developer toil.
• Product Feedback (\"Customer Zero\"): You will be the first to test new agent capabilities. You'll document friction points in the Agentic SDLC (AISDLC) and advocate for community-requested features in roadmap meetings with our CTO and engineering teams.
• Developer Education: Build and maintain \"Get Started\" templates that reduce time-to-value

Required Skills:

• Technical Background: 3+ years of experience in software engineering (Python, Go, or JavaScript). Familiarity with LLM orchestration frameworks and CI/CD tools is a major plus.
• Communication: Proven ability to explain complex \"Agentic\" concepts—such as prompt engineering for DevOps or automated remediation—to both platform engineers and developers.
• Portfolio: A public presence, such as a technical blog, active GitHub repository featuring automation projects, or a history of speaking at AI meetups.

A well-funded startup with strong enterprise traction is building a category-defining AI workbench to accelerate enterprise AI adoption.

The platform ingests messy, real workflows, automates them end-to-end, and continuously learns from human decision-making. This is a customer-focused, hands-on engineering role centred on shipping reliable, production-ready AI systems.

As a Customer facing Full stack Engineer, you'll partner with customers, product, and engineering to build and scale AI directly within enterprise workflows.

What You'll Do

• Build and deploy AI-powered features across frontend, backend, and platform

• Implement LLM systems including RAG, embeddings, agents, and document processing

• Rapidly prototype using real customer data and iterate quickly

• Ship user-facing AI with strong guardrails, reliability, and UX

• Optimize for performance, latency, safety, and scale

• Contribute to architecture, testing, and production readiness

• Develop reusable platform components and prompt frameworks

What You Bring

• BS required, Master's preferred

• Experience in a Forward Deployed Engineering role

• Proven track record deploying AI systems into production

• Strong hands-on experience with LLMs and RAG

• Solid software engineering fundamentals

• Comfort in 0 to 1, early-stage environments

• Familiarity with enterprise workflows and unstructured data

Compensation

• Up to $350,000 total comp

• Strong bonus

• Competitive equity

• Hybrid, 3 days onsite in Palo Alto

You'll help transform fragmented enterprise workflows into a continuously improving AI platform, shaping a product already seeing strong demand.

Head of Operations and Manufacturing Ripple Medical | California (Hybrid or Remote) | Full-Time

ABOUT RIPPLE MEDICAL

Ripple Medical is a health tech company on a mission to revolutionize hypertension management with our cuffless blood pressure wearable. Once cleared by FDA, our product will enable patients to easily and accurately monitor blood pressure at home, empowering them and their providers with actionable data to improve outcomes. We're a collaborative, mission-driven team of 33 working in a medical device regulatory environment to bring this technology to the millions of patients who can benefit.

POSITION SUMMARY

The Head of Operations and Manufacturing will own the end-to-end operational infrastructure required to bring Ripple's FDA-regulated cuffless blood pressure monitor to market and scale production. This is a hands-on leadership role for someone who thrives building from zero to one in a regulated environment: selecting contract manufacturers, standing up supply chains compliant with FDA 21 CFR Part 820, establishing ISO 13485-certified quality management systems, and preparing for direct-to-patient fulfillment.

As a company preparing for 510(k) submission and commercial launch, this role is critical to ensuring we can reliably manufacture and deliver a high-quality, FDA-cleared medical device at scale. The ideal candidate brings deep experience in medical device manufacturing (particularly wearable or electro-optical devices), understands regulated hardware supply chains and design transfer, and can roll up their sleeves while building the team and processes for long-term growth.

This position reports directly to the CEO with high visibility to the leadership team and Board of Directors.

KEY RESPONSIBILITIES

Manufacturing & Production

• Lead selection and onboarding of contract manufacturing partners with Class II medical device experience, including RFQ, quality audits, contract negotiation, and ongoing management.
• Own design transfer and manufacturing transfer, working with engineering on DFM principles, Device Master Record (DMR) requirements, and production readiness.
• Establish production planning, forecasting, and capacity management for V&V builds, pilot production, and volume manufacturing.
• Drive continuous improvement in yield, quality, and cost while maintaining FDA and ISO compliance.
• Oversee pilot runs and scale-up, including process validation (IQ/OQ/PQ) and manufacturing controls.

Supply Chain & Procurement

• Build and manage the end-to-end supply chain, including component sourcing, supplier qualification, and inventory management per FDA purchasing controls.
• Develop supplier relationships and negotiate terms while ensuring supply continuity, traceability, and risk mitigation.
• Implement inventory planning to balance working capital with service levels, including buffer strategies for Year 1 launch.
• Monitor and mitigate supply chain risks: component shortages, single-source dependencies, geopolitical factors, and logistics disruptions.

Quality & Regulatory Compliance

• Maintain and improve the ISO 13485-certified QMS in partnership with the quality and regulatory team, ensuring FDA 21 CFR Part 820 compliance.
• Support 510(k) submission activities related to manufacturing, including process validation documentation, DMR development, and device history records (DHR).
• Define incoming inspection, in-process controls, and final product testing consistent with the risk management file.
• Manage product certifications for a Class II device, including FDA registration, UDI compliance, and applicable international requirements.
• Lead root cause analysis and CAPA for quality issues, ensuring post-market surveillance compliance.

Fulfillment & Logistics

• Design the direct-to-patient fulfillment strategy, including 3PL selection with FDA-cleared Class II device experience.
• Establish logistics and distribution for nationwide shipping of a regulated device with chain-of-custody and traceability.
• Develop returns, replacement, and warranty processes that balance patient experience, cost, and compliance.

Team & Organizational Development

• Start as an individual contributor who executes hands-on, then build and lead the operations team through 510(k) clearance and commercial launch.
• Establish operational metrics and dashboards for manufacturing, supply chain, and quality performance.
• Partner with finance on cost modeling, COGS optimization, and operational budgeting.
• Collaborate cross-functionally with engineering, software, regulatory, and commercial teams.

QUALIFICATIONS

• 7-12 years in manufacturing, operations, or supply chain, with 3-5+ years in medical devices (Class II preferred), wearables, or regulated hardware.
• Experience managing contract manufacturers for regulated medical devices, preferably in Asia and/or domestically.
• Experience at or with CMs/EMS providers (Flex, Jabil, Celestica, Plexus, Sanmina) in Class II medical device or wearable programs is a strong plus.
• Track record of design transfer and scaling production from pilot to volume for regulated products.
• ISO 13485 and FDA 21 CFR Part 820 experience required.
• Familiarity with the 510(k) process and manufacturing documentation (process validations, DMR/DHR) strongly preferred.
• Bachelor's in Engineering, Supply Chain, Operations, Biomedical Engineering, or related field; MBA or advanced degree a plus.
• Based in California or travel up to 25%.

COMPENSATION

• Base Salary: $160,000 - $210,000 USD
• Performance Bonus: Tied to company milestones and personal objectives
• Equity: Early-stage stock option grant with meaningful ownership
• 100% Employer-Paid Healthcare: Medical, dental, and vision
• Additional Benefits: 401(k) with company match, flexible PTO