Engineering Structures Jobs No Experience Jobs in Pacifica, CA

At Two Bear Capital we believe in partnering with our portfolio companies to build the best teams possible. We look forward to working with you and Rainfall Health on their new Director of Software Engineering role.

Director of Software Engineering (AWS Amplify & Digital Health)

*please note that this role requires willingness to travel to the Bay area and/or relocating to the Bay area

*please note that this position requires US citizenship/does not provide sponsorship

About Rainfall Health

Rainfall Health is an AI-powered compliance and workflow platform helping health systems succeed under CMS’s TEAM Model and other value-based care programs. We partner with hospitals, surgeons, and care teams to improve episode performance, streamline operations, and maximize reimbursement — all while supporting better patient outcomes.

Our platform sits at the intersection of clinical workflows, financial performance, and intelligent automation.

The Role

We are looking for a Director of Software Engineering with deep experience in AWS Amplify and modern cloud-native architectures to help build and scale our digital health platform. You’ll play a key role in designing secure, reliable systems that integrate with healthcare data sources and surface actionable insights to clinical and operational teams.

This role is ideal for someone who enjoys solving complex data and workflow challenges in a regulated healthcare environment.

What You’ll Do

Platform & Application Development

• Design, build, and maintain scalable web applications using AWS Amplify, serverless services, and modern frontend frameworks
• Develop robust APIs and backend services using AWS-native tools (e.g., AppSync, Lambda, DynamoDB, RDS)
• Ensure performance, reliability, and security across distributed cloud systems

Healthcare Data & Integrations

• Build and maintain integrations with Electronic Health Records (EHRs) and other healthcare systems
• Work with healthcare interoperability standards such as FHIR, HL7, and APIs from major EHR vendors
• Design data ingestion pipelines that normalize, validate, and securely store clinical and operational data

Data Visualization & Insights

• Develop interactive dashboards and data visualization tools for clinical and operational users
• Translate complex healthcare data into intuitive, actionable insights
• Collaborate with product and design teams to create user experiences tailored to care teams and administrators

Cross-Functional Collaboration

• Work closely with product managers, designers, and clinical stakeholders to deliver features aligned with real-world workflows
• Contribute to architectural decisions and technical roadmap planning
• Mentor other engineers and promote best practices in code quality, testing, and security

Security & Compliance

• Implement best practices for HIPAA-compliant infrastructure and data handling
• Ensure systems meet high standards for privacy, auditability, and reliability in a healthcare environment

What We’re Looking For

Required:

• 8+ years of software engineering experience building production-grade applications
• Hands-on experience with AWS Amplify and serverless AWS architectures
• Strong experience with modern JavaScript/TypeScript frameworks (e.g., React, Next.js, Vue)
• Experience building and consuming RESTful and/or GraphQL APIs
• Solid understanding of cloud security and best practices for handling sensitive data

Preferred:

• Experience in digital health, healthcare IT, or healthtech startups
• Experience integrating with EHR systems (Epic, Cerner, Meditech, etc.)
• Familiarity with FHIR, HL7, CCD, or other healthcare data standards
• Experience building data visualization tools (e.g., D3, Chart.js, Recharts, or BI tools)
• Knowledge of healthcare compliance frameworks (HIPAA, HITRUST, SOC 2)

Nice to Have

• Experience with real-time data pipelines or event-driven architectures
• Background in analytics, population health, or value-based care technology
• DevOps experience with CI/CD pipelines and infrastructure as code

What Success Looks Like

• Seamless, secure integrations with healthcare systems
• Intuitive dashboards that drive decision-making for clinical and operational teams
• A scalable, maintainable architecture that supports rapid product growth
• Strong engineering culture centered on reliability, security, and user impact

Fractal is a strategic AI partner to Fortune 500 companies, with a bold vision: to power every human decision in the enterprise. We believe the future belongs to organizations that combine human imagination with intelligent systems—and Fractalites are the ones building that future. As we scale our Technology, Media & Telecom (TMT) practice in the United States, we are looking for a senior, client-facing Head of Engineering to shape and deliver world-class Data & AI platforms for leading Technology, Media & Telecom organizations.

This is not a back-office engineering role. This is a consulting-led, client-facing engineering leadership position for someone who is equally comfortable whiteboarding architecture with principal engineers, rolling up their sleeves with delivery teams, and advising CIOs, CTOs, and CDOs in the boardroom.

Learn more at Fractal | Intelligence for Imagination.

Note: This position is not eligible for Immigration Sponsorship at this time.

About the Role

This is a four-axis leadership role requiring technical depth, executive presence, team leadership, and embedded delivery. You'll work directly with top technical and functional leaders at some of the largest TMT companies in the world.

As Head of Engineering for Fractal's Technology, Media & Telecom (TMT) vertical, you will personally shape the architecture of mission-critical AIML platforms, often in first-party tech stack, and develop/drive the team of ICs who bring them to life.

Responsibilities

Some engagements will look like a traditional advisory model. Others will look a lot more like Forward Deployed Engineering: your team embedded inside a client's engineering org, working within their first-party tech stack, shipping production code alongside their engineers, and earning influence through technical credibility, not org chart position.

You will need to be in the room when the technology roadmap needs to change. When a business pivot, a new regulation, or a technology shift forces a rethink mid-execution, you are the person who picks up the marker, walks to the whiteboard, and redraws the architecture in real time, credibly, for the CTO, and Principal Engineering leaders simultaneously.

Technical Depth (Hands-On Architecture)

• Own AI/Data platform architecture decisions — from Lakehouse design and real-time streaming to MLOps, LLMOps, and AgentOps pipelines in production
• Serve as the technical authority for Fractal's TMT engineering practice — defining standards, reviewing design, and holding the bar on reliability, scalability, and security
• Translate ambiguous business problems into concrete, buildable platform architectures — and stay close enough to execution to know when something is not working
• Drive the industrialization of GenAI: moving clients from proof-of-concept to enterprise-grade, governed, and observable AI systems

Executive Presence & Live Architectural Thinking

• Command the room with senior client leadership — CIOs, CTOs, CDOs, and their direct reports - as a peer, not a vendor
• Whiteboard new architectural directions on the spot: when a business pivot, acquisition, regulatory shift, or technology breakthrough forces a mid-execution rethink, you synthesize it into a credible, buildable path forward live, in the room, without needing a week to prepare a deck
• Translate between two worlds simultaneously: make the architecture legible to a CFO and rigorous enough to satisfy a principal engineer in the same session
• Shape client roadmaps at the strategic level; identifying where the current plan is under-ambitious, over-engineered, or misaligned with emerging AI capabilities, and steering accordingly
• Represent Fractal at the highest level of client relationship

Team Leadership (Building & Driving Senior ICs)

• Develop and lead a high-performing group of individual contributors. principally senior and staff engineers, ML engineers, and data platform engineers
• Create the engineering culture: rigorous delivery standards, architectural thinking, and a bias toward elegant, production-grade solutions over quick fixes
• Build leadership depth within the team, identifying principals who can own programs and grow into broader roles
• Partner across Fractal's global AI and engineering Capability functions to staff programs strategically and raise capability across the TMT practice

Forward-Deployed & Embedded Delivery

• Lead and run FDE-style engagements where your team operates inside the client's engineering environment
• Navigate and deliver within client-owned, first-party technology stacks: proprietary data platforms, internal ML infrastructure, custom orchestration systems, and bespoke toolchains that do not appear in any industry survey
• Adapt quickly to non-standard environments, understanding a client's internal platform deeply enough to extend it, integrate into it, and earn the trust of their engineering staff
• Balance the tension between what Fractal does best and what the client's stack demands, knowing when to bring pattern, when to adapt, and when to advocate for a better path
• Set the standards for how Fractal operates in deeply embedded engagements: how we onboard, document, transfer knowledge, and leave clients stronger than we found them

Candidate Profile

Technical Qualifications

TMT clients bring genuinely hard problems on both open and proprietary infrastructure. Expect to architect and oversee:

• GenAI systems: RAG architectures, LLM fine-tuning pipelines, agentic workflow orchestration, and LLMOps observability
• AI-powered products: personalization engines, churn prediction, content recommendation, and network fault detection
• Client-proprietary ML infrastructure: internal feature stores, custom model serving layers, bespoke experiment tracking systems, and first-party orchestration frameworks
• Cloud-native infrastructure across AWS, Azure, and GCP with enterprise-grade governance, security, and compliance baked in
• Real-time and event driven data pipelines (e.g. network telemetry)
• Modern Lakehouse platforms (Databricks, Snowflake, Delta Lake, Iceberg) at petabyte scale and proprietary data platform equivalents at leading tech-forward TMT organizations

Non-technical Qualifications

We are particularly interested in leaders from environments where engineering rigor, client accountability, executive presence, and AI depth all coexist including Forward Deployed Engineering, elite data/ML platform teams, and senior hyperscaler architecture practices.

• 15–20 years of experience spanning AI/data engineering and technical leadership with clear evidence of owning architecture at scale
• Deep hands-on experience deploying AI/ML/GenAI systems in production, in addition to advising on them
• Demonstrated executive presence: you have walked into a CTO or CDO review, redrawn the architecture based on new constraints, and left the room with alignment
• The ability to whiteboard fluently under pressure, synthesizing a team's in-flight work with a new business direction, making it rigorous enough for engineers and clear enough for executives, on the spot and without a rehearsal
• Experience operating within client-owned or non-standard technology stacks - you have learned a proprietary system, earned trust from skeptical internal engineers, and delivered production-grade results inside someone else's infrastructure
• A track record of leading senior engineers and building high-performance ML/engineering teams, including hiring, coaching, and developing principal-level ICs
• Direct executive engagement experience - you have influenced CIO/CTO/CDO decisions and can hold your own in a room with technical and non-technical stakeholders at once
• Strong cloud-native fluency across one or more hyperscalers, with genuine depth in data platform patterns (streaming, batch, Lakehouse, governance)

Strong Preferences

• Experience in TMT vertical — hi-tech, telco, media platforms, streaming infrastructure, ad tech, or content delivery at scale
• Prior work in FDE-style or embedded delivery models where your team shipped inside a client codebase and was evaluated by their engineering standards, not just deliverable milestones
• Comfort with the ambiguity of 1P stack environments: you have debugged undocumented internal tools, extended proprietary frameworks, and figured out how to make external expertise land inside a closed ecosystem
• A personal reputation for architectural clarity: the person colleagues call when a problem needs to be drawn, not just describe
• Contributions to the ML/AI community: open source, publications, conference talks, or influential architectural patterns

Who Thrives Here

The Fractalite mindset is curious, rigorous, and impact driven. You will thrive in this role if you:

• Enjoy being client-facing and accountable for outcomes.
• Are comfortable navigating ambiguity, scale, and complex stakeholder environments.
• Believe great platforms come from strong engineering culture plus disciplined execution.
• See AI not as a novelty, but as a core enterprise capability that must be engineered responsibly.

Fractal provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Role: Engagement Manager– Digital Health Experience

Location: Remote (U.S.)

Duration: 6-Month Contract

Working Time Zone: PST (Pacific Time Zone)

Position Overview

We are seeking a Engagement Manager– Digital Health Experience to lead the deployment, adoption, and engagement optimization of mobile digital health applications within the U.S. healthcare ecosystem. This role requires a hands-on professional with strong experience in launching digital health platforms, managing deployments, and driving sustained patient engagement through data-driven engagement strategies.

The ideal candidate will have experience deploying consumer-facing healthcare applications used by patients across providers and payer organizations, while leveraging engagement tools and analytics platforms to improve patient adoption, retention, and usage metrics such as DAU/MAU.

This role will work closely with product, engineering, digital marketing, and care management teams to ensure successful rollout of mobile applications and to design engagement loops that increase patient participation and long-term platform usage.

Key Responsibilities

• Lead deployment and rollout of mobile digital health applications across healthcare provider or payer environments.
• Manage end-to-end implementation and project management of digital health platforms, ensuring successful launches and smooth adoption by patient populations.
• Design and implement patient engagement strategies and engagement loops to drive consistent application usage and retention.
• Utilize engagement platforms such as , Intercom, Mixpanel, or similar tools to design communication workflows, patient messaging, and engagement campaigns.
• Monitor and optimize digital engagement metrics, including DAU, MAU, retention rates, and user engagement trends.
• Analyze user behavior data and analytics to improve patient onboarding, engagement journeys, and digital experience.
• Collaborate with product, analytics, and engineering teams to continuously enhance patient engagement features and workflows.
• Coordinate with healthcare stakeholders to ensure digital tools align with clinical workflows and patient care programs.

Required Qualifications

• Strong experience in deploying and managing digital health applications within healthcare provider or payer environments.
• Hands-on experience in project management and platform implementation for consumer-facing digital products.
• Experience driving user engagement, retention, and adoption for mobile or digital applications.
• Familiarity with engagement platforms such as , Intercom, Mixpanel, or similar customer engagement and analytics tools.
• Experience tracking and optimizing digital engagement metrics such as DAU, MAU, retention, and user lifecycle engagement.
• Strong analytical and problem-solving skills with the ability to translate data insights into engagement improvements.

Preferred Qualifications

• Experience working within digital health, healthcare technology, or healthcare consumer platforms.
• Familiarity with healthcare ecosystems including provider systems, payer platforms, and patient engagement solutions.
• Experience integrating engagement tools with mobile health applications or digital health platforms.
• Background working with health systems, health plans, digital health startups, or healthcare technology consulting firms.

Job Description:

Mandatory to have working experience as SRE manager especially in Retail domain application support ( NOT CLOUD /DevOps)

Must have working knowledge on SRE principles such as Logs, metrics, availability metrics, uptime, ticket tracking, e-com services, ITIL framework specifically on Alerts, Incident, change management, CAB, Production deployments, Risk and mitigation plan, SLA, SLI, SLO

Hands on experience in Monitoring, Logging, Alerting, Dashboarding, and report generation in any observability tools Prefer DataDog or other tools such as Splunk/Dynatrace/ELK/Grafana). This engagement is a customer using Dynatrace,Splunk, PagerDuty hence it is good to have this expertise

Mandatory to have work experience in leading Level 2/Level 3 application support team based out of IND who provide 24x7 coverage.

Should know how to gather & communicate SRE requirement from customers and define SRE roadmap.

Working experience on how to gather requirements on health of applications, services to monitor, setting service levels.

Must have good knowledge on eCommerce platforms in microservice architecture, Sterling OMS , Retail Applications like XStore.

Should be able to lead P1 calls, brief about the P1 to customer, proactive in gathering leads/ customers into the P1 calls till RCA, PIR etc.

Should have knowledge on building process , framework by following ITSM principles, SOP, runbooks, handling any ITSM platforms (JIRA/ServiceNow/BMC Remedy)

Must know how to work with the Dev team, cross functional teams.

Should be able to generate WSR/MSR by extracting the tickets from ITSM platforms, present to customers and client leaders.

Manage overall SRE delivery, customer focus mindset , closely work with customer leaderships.

Preferred:

Be a client face at customer site collaborating with client leadership.

Ability to clearly communicate and understand a technical idea/concept.

Ability to work in a professional environment while interacting with peers and stakeholders, collaborating with offshore teams.

Excellent written and verbal communications skills.

Motivated, goal driven, influential, innovative, curious, and open minded, fun to work with, collaborator.

Capability to work with people in different time zones.

Ability to operate in a fast-paced, evolving environment and appropriately prioritize tasks, and keep abreast of the latest technology.

Collaborate with cloud architecture, infrastructure team, project management team, and technology services, management team.

Create and maintain detailed documentation.

Mission for this Position

The mission of the Caregiver (Memory Care Professional) is to improve quality of life for Tender Rose clients and their families. The Caregiver (MCP) will provide non-medical companionship care for clients living with Alzheimer’s and other forms of dementia. Our caregivers (MCPs) deliver person-centered, activity-based care focused around luxury-brand customer service to improve the mood and quality of life for their clients, families and other caregivers. 

What We Offer 

• Health, Dental and Vision insurance
• 401(k) with matching
• Paid sick leave
• Employee Assistance Program
• Paid training starting at $20.10/hr
• Opportunities for growth
• 24/7 Support
• Consistent schedules with weekly pay

Schedule 

• Full Time schedule: 8hr shifts, Sunday-Thursday or Tuesday-Saturday.
• Part time schedule: 4hr shifts

Responsibilities

• Caregivers follow customized care plans that are designed to meet the clients’ fundamental needs, even as the disease progresses.
• Assist clients with ADLs and personal care activities, including hygiene, mobility assistance, incontinence care, and feeding.
• Perform light housekeeping, meal preparation, and transportation to and from outings and appointments.
• Must be able to drive own vehicle to and from outings and appointments.
• Document completion of tasks, and promptly communicate changes in client’s physical condition, mental capacity, or behavior.

Qualifications

• Minimum of 1 year of professional caregiving experience 
• Minimum of 1 year Dementia/Alzheimer care experience
• Ability to lift a minimum of 50 pounds
• Valid Driver’s License and vehicle with current registration and insurance 
• Ability to pass a background check
• Proof of eligibility to work in the U.S.
• Home Care Aide clearance with the State of CA

In accordance with Article 2 of the California Health and Safety Code - California Community Care Facilities Act, TheKey requires timely and accurate positive fingerprint identification of applicants as a condition of employment. If an applicant has been convicted of a non-exemptible crime, and in compliance with all applicable state and local laws, their conditional offer will be rescinded.

Founding SDR role with a clear path to Account Executive

You'll be the first dedicated outbound hire and will work directly with the founding team.

About ZeroPath

ZeroPath is helping everyone from startups to the Fortune 500 and open-source projects like curl, sudo, Linux, FFmpeg, and OpenSSL find vulnerabilities that years of community scrutiny and traditional scanners missed.

ZeroPath maps and understands code in depth, analyzing code, dependencies, and infrastructure to understand how systems actually behave before tracing full attack paths and verifying exploitability. That deep understanding lets ZeroPath detect real issues including business logic flaws, authentication bypasses, and multi-step attack paths, while lowering noise dramatically compared to traditional tooling.

For our customers, we deliver better detection, massive noise reduction, and high-quality automated patches that shrink backlogs and improve developers' lives.

Stage:

• YC-backed, $12.5M seed. RSAC Innovation Sandbox Top 10 Finalist.
• Engineering teams actively replacing all traditional scanners with ZeroPath
• Team of 10 doing the work of 100; you'll be joining early

Why this role exists

Security engineers and engineering leads already convert once they see what ZeroPath catches. The constraint is getting in front of the right people at the right companies. You'll fix that.

This is a high-signal, research-driven outbound role. You're not working off a purchased list and blasting templates. You're identifying companies with real attack surface, understanding their stack, and writing messages that demonstrate you know their world.

Target: 20+ qualified held meetings per month on the founders' calendars.

What you'll do:

• Research targets deeply. Understand a company's tech stack, open-source dependencies, recent funding, and security posture before you write a single word.
• Write technical outbound that earns replies from CTOs, VPs of Engineering, and security leads — people who delete 50 generic emails a day.
• Work warm and inbound leads from product-led signups, content, and conferences. Follow up fast and with context.
• Run multi-channel sequences across email, LinkedIn, phone, and creative touchpoints. If sending a security audit of their public GitHub repos gets the meeting, do that.
• Attend and work security and developer conferences: Staff the booth, set meetings on the floor, and run same-day follow-up.
• Keep Attio, Pylon tight. call notes, deal stages, next steps, no stale records.

What we're looking for

• 1+ years of outbound SDR experience, ideally selling a technical product to engineering or security buyers
• You can talk shop. You don't need to be a security researcher, but you should be able to hold a conversation about SAST vs. DAST, what a CVE is, why false positives kill adoption, and how CI/CD pipelines work. If you can't today, you're the type who'll learn it in a week.
• Your writing is sharp. You can write a 3-sentence cold email that a VP of Engineering actually reads. No fluff, no "I hope this finds you well."
• You're resourceful and relentless. You find the right person, figure out what they care about, and get creative about reaching them.
• You're organized under volume. You can run 200+ active contacts without dropping balls.
• You want to close. This role has a clear ramp to AE — you're here because you want to earn that seat.
• Tools: Be proficient in using clay, lemlist, and any other form of outbound tool. If needed, you should be able to create pipelines via APIs/Webhooks, though that would be rare. You should be able to connect the dots in terms of signals: a hot lead in LinkedIn Ads, the same pattern in website visitors, a competitor we can replace very easily, and more. 

Background doesn't look typical? Apply anyway. We care about signal over pedigree.

Comp & Benefits

• $90–150k OTE (base + variable), with quota ramped for the first 60 days
• Equity in an early-stage, YC-backed company
• Health, dental, vision
• Work directly with the founding team on GTM strategy

Our client, a Fortune 500 retail organization with a nationwide distribution network, is seeking a Strategic Sourcing Manager to support large-scale construction and facilities engineering procurement initiatives across their supply chain network.

This role plays a key part in sourcing industrial construction materials, equipment, and services for new facility builds, expansions, and ongoing engineering initiatives. The individual will partner closely with engineering, property development, legal, finance, and operations teams to design sourcing strategies that deliver cost efficiency, risk mitigation, and supplier performance improvements.

The ideal candidate will bring deep expertise in construction procurement, contract negotiation, and cost modeling, with the ability to influence stakeholders and drive complex sourcing projects from concept through execution.

Projects You’ll Work On

• Leading end-to-end strategic sourcing initiatives for industrial construction and facilities engineering categories.
• Developing sourcing strategies for categories such as steel structures, concrete, MEP systems, material handling equipment, racking systems, conveyors, and site services.
• Managing the full sourcing lifecycle including market research, supplier identification, RFP development, bid management, negotiations, and contract execution.
• Conducting construction cost analysis, clean-sheet modeling, and should-cost modeling to identify optimal pricing and savings opportunities.
• Partnering with engineering and development teams to support distribution center construction, expansions, and infrastructure upgrades.
• Managing supplier relationships and performance through KPIs, quarterly business reviews (QBRs), and executive-level supplier meetings.
• Performing spend analysis and market intelligence research to anticipate supply risks and pricing fluctuations.
• Driving cost optimization through value engineering, competitive bidding, and strategic negotiations.
• Supporting facilities engineering teams with sourcing for material handling equipment repair, refurbishment, and replacement.
• Developing presentations and recommendations for executive leadership to support strategic sourcing decisions.

What Experience You Should Bring

• Bachelor’s degree in Supply Chain, Construction Management, Engineering, Finance, Economics, or Business (MBA or advanced degree preferred).
• 5+ years of strategic sourcing or category management experience focused on industrial construction or facilities engineering procurement.
• Experience managing large-scale sourcing projects for construction materials, contractors, or engineering services.
• Strong understanding of construction cost estimation, budgeting, and material cost drivers.
• Experience leading RFP/RFQ processes, supplier negotiations, and contract development.
• Ability to analyze supplier bids using TCO modeling, cost analysis, and financial modeling.
• Experience working cross-functionally with engineering, legal, finance, and project management teams.

What Will Help You Stand Out

• Familiarity with distribution center construction, logistics infrastructure, or retail supply chain environments.
• Experience working with construction management software (e.g., Procore) and sourcing platforms (e.g., Coupa).
• Knowledge of regulatory frameworks such as OSHA, LEED, and construction compliance standards.
• Professional certifications such as CPSM, CCM, or CCPS.
• Strong financial acumen including experience analyzing budgets, cash flow, and cost structures.
• Advanced Excel skills (pivot tables, VLOOKUPs, data modeling) and strong presentation capabilities.

Work Environment

• Hybrid role with regular in-office collaboration and occasional travel to facilities and project sites.
• Ability to manage multiple sourcing projects simultaneously in a fast-paced, cross-functional environment.

Compensation & Benefits

The base salary range for this position is up to $200,000.00, depending on experience and qualifications.

The total rewards package may include performance incentives, health benefits, retirement plans, and professional development opportunities.

Senior Manufacturing Process Engineer

Meet has partnered with an exciting Stealth start-up in the Brain-Computer Interface (BCI) space based in the San Francisco Bay area. The company is developing cutting-edge medical devices and technology for the treatment of unmet neurological disorders. The Head of Operations is seeking an experienced Manufacturing Process Engineer to support NPI of electro-mechanical devices in collaboration with suppliers.

This role will focus on hands-on interaction with suppliers to develop manufacturing processes, tooling, and documentation, from design feasability through commercial release. This role will require real-time engagement and technical support of suppliers, and this individual will be expected to travel often to domestic supplier sites and occasionally to international suppliers.

Primary Responsibilities:

• Serve as the primary technical liaison to external manufacturing partners, ensuring successful delivery of components, assemblies, and finished devices
• Collaborate with product development teams to ensure designs are manufacturable and compliant with medical device quality system requirements
• Develop and maintain manufacturing documentation, including work instructions, process flows, and validation protocols
• Support supplier implementation of specifications, manufacturing processes, and quality requirements
• Lead and participate in process validation activities including IQ/OQ/PQ, PFMEA, and failure investigations
• Drive continuous improvement initiatives related to manufacturing efficiency, quality, cost, and scalability
• Support resolution of non-conformances and corrective actions with suppliers
• Ensure manufacturing activities comply with applicable regulatory requirements (FDA, ISO 13485, EU MDR, etc.)
• Provide hands-on technical support to suppliers, including travel as needed (domestic and international)

Role Requirements:

• B.S. in relevant engineering discipline, or equivalent experience.
• 10 or more years of medical device manufacturing experience, preferably in senior roles at start-up companies developing and manufacturing electro-mechanical devices.
• Experience with active implantable systems (Implant, Leads, Externals, etc.).
• Experience with medical device manufacturing including molding, laser welding, clean room assembly, packaging, labeling, and sterilization.
• Experience with electronic manufacturing and test including PCB fab, PCA assembly, microelectronics assembly, flip chip, in circuit test (ICT) and functional test.
• Experience with manufacturing automation.
• Experience in defining and executing process validation activities.
• Experience collaborating with internal customers and external partners.
• Understanding of and experience implementing validating manufacturing processes for medical devices in accordance with FDA and EU Requirements.
• Experience with Solidworks, Labview / manufacturing process and test automation software.
• Ability to travel to Domestic and International supplier sites frequently

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Compensation:

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Benefits:

• Flexibility to take part in discussions online or in-person.
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• Enjoy free samples from our sponsors and partners in exchange for your honest feedback of their products.
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Qualifications:

• Speak and/or read English
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Experience:

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Education:

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