Engineering Journal Jobs in Sunol, CA

Staff Data Scientist – Sales Analytics

Location: San Francisco (Hybrid)

Salary: $200–250k base + RSUs

This fast-growing Series E AI SaaS company is redefining how modern engineering teams build and deploy applications. We're looking for a Staff Data Scientist to drive Sales and Go-to-Market (GTM) analytics, applying advanced modeling and experimentation to accelerate revenue growth and optimize the full sales funnel.

About the Role

As the senior data scientist supporting Sales and GTM, you will combine statistical modeling, experimentation, and advanced analytics to inform strategy and guide decision-making across our revenue organization. Your work will help leadership understand pipeline health, predict outcomes, and identify the levers that unlock sustainable growth.

Key Responsibilities

• Model the Business: Build forecasting and propensity models for pipeline generation, conversion rates, and revenue projections.
• Optimize the Sales Funnel: Analyze lead scoring, opportunity progression, and deal velocity to recommend improvements in acquisition, qualification, and close rates.
• Experimentation & Causal Analysis: Design and evaluate experiments (A/B tests, uplift modeling) to measure the impact of pricing, incentives, and campaign initiatives.
• Advanced Analytics for GTM: Apply machine learning and statistical techniques to segment accounts, predict churn/expansion, and identify high-value prospects.
• Cross-Functional Partnership: Work closely with Sales, Marketing, RevOps, and Product to influence GTM strategy and ensure data-driven decisions.
• Data Infrastructure Collaboration: Partner with Analytics Engineering to define data requirements, ensure data quality, and enable self-serve reporting.
• Strategic Insights: Present findings to executive leadership, translating complex analyses into actionable recommendations.

About You

• Experience: 6+ years in data science or advanced analytics roles, with significant time spent in B2B SaaS or developer tools environments.
• Technical Depth: Expert in SQL and proficient in Python or R for statistical modeling, forecasting, and machine learning.
• Domain Knowledge: Strong understanding of sales analytics, revenue operations, and product-led growth (PLG) motions.
• Analytical Rigor: Skilled in experimentation design, causal inference, and building predictive models that influence GTM strategy.
• Communication: Exceptional ability to tell a clear story with data and influence senior stakeholders across technical and business teams.
• Business Impact: Proven record of driving measurable improvements in pipeline efficiency, conversion rates, or revenue outcomes.

At OneNotary, we are transforming the notary industry by making secure, fast, and accessible online notarization available anytime, anywhere. Trusted by tens of thousands of businesses across the U.S., our platform powers critical transactions for individuals and enterprises in highly regulated environments.

As we continue to scale, we are looking for experienced leaders to help deliver operational excellence and a best-in-class customer experience.

We are seeking a Director of Notary Operations to lead and scale OneNotary's nationwide notary network. This role is responsible for ensuring high-quality, compliant, and efficient notary services while continuously improving the experience for both business clients and individual signers.

Reporting to executive leadership, the Director will work closely with Product, Engineering, Compliance, and Customer Success teams to optimize operations, strengthen quality standards, and support platform growth.

• Lead and scale OneNotary's notary operations team and nationwide network of remote notaries.
• Establish training, certification, and onboarding programs to ensure notaries meet high standards of professionalism, compliance, and customer service.
• Implement quality assurance processes including audits, coaching, and performance monitoring.
• Ensure adherence to state-specific notary laws and RON regulations.
• Manage workforce planning and session fulfillment to maintain strong service levels.
• Track operational KPIs and drive improvements in efficiency, quality, and customer satisfaction.
• Partner with Product and Engineering to improve tools and workflows for notaries and customers.

• 10+ years of leadership experience in operations, customer experience, or service delivery.
• Experience building and managing distributed or remote teams.
• Strong background in training, quality management, and operational process improvement.
• Experience in regulated industries such as legal tech, fintech, or SaaS preferred.
• Data-driven leader with strong cross-functional collaboration skills.

Staff Data Scientist – Post Sales

Location: San Francisco (Hybrid)

Salary: $200–250k base + RSUs

This fast-growing Series E AI SaaS company is redefining how modern engineering teams build and deploy applications. We're expanding our data science organization to accelerate customer success after the initial sale—driving onboarding, retention, expansion, and long-term revenue growth.

About the Role

As the senior data scientist supporting post-sales teams, you will use advanced analytics, experimentation, and predictive modeling to guide strategy across Customer Success, Account Management, and Renewals. Your insights will help leadership forecast expansion, reduce churn, and identify the levers that unlock sustainable net revenue retention.

Key Responsibilities

• Forecast & Model Growth: Build predictive models for renewal likelihood, expansion potential, churn risk, and customer health scoring.
• Optimize the Customer Journey: Analyze onboarding flows, product adoption patterns, and usage signals to improve activation, engagement, and time-to-value.
• Experimentation & Causal Analysis: Design and evaluate experiments (A/B tests, uplift modeling) to measure the impact of onboarding programs, success initiatives, and pricing changes on retention and expansion.
• Revenue Insights: Partner with Customer Success and Sales to identify high-value accounts, cross-sell opportunities, and early warning signs of churn.
• Cross-Functional Partnership: Collaborate with Product, RevOps, Finance, and Marketing to align post-sales strategies with company growth goals.
• Data Infrastructure Collaboration: Work with Analytics Engineering to define data requirements, maintain data quality, and enable self-serve dashboards for Success and Finance teams.
• Executive Storytelling: Present clear, actionable recommendations to senior leadership that translate complex analysis into strategic decisions.

About You

• Experience: 6+ years in data science or advanced analytics, with a focus on post-sales, customer success, or retention analytics in a B2B SaaS environment.
• Technical Skills: Expert SQL and proficiency in Python or R for statistical modeling, forecasting, and machine learning.
• Domain Knowledge: Deep understanding of SaaS metrics such as net revenue retention (NRR), gross churn, expansion ARR, and customer health scoring.
• Analytical Rigor: Strong background in experimentation design, causal inference, and predictive modeling to inform customer-lifecycle strategy.
• Communication: Exceptional ability to translate data into compelling narratives for executives and cross-functional stakeholders.
• Business Impact: Demonstrated success improving onboarding efficiency, retention rates, or expansion revenue through data-driven initiatives.

Company Description

Whissle is bridging the missing link in multi-modal AI. We are moving beyond the slow, broken \"turn-based\" experience of current AI solutions to pioneer Streaming Intelligence. Our platform continuously interprets meaning from live multi-modal input streams (voice, text, visual) to trigger instant, contextual actions and achieve faster task completion. This zero-wait, real-time approach creates a hands-free, hyper-personalized, and ambient interaction experience.

Role Description

As the VP of Product, Streaming Intelligence, you will be the definitive product owner and strategist for Whissle's core technology and APIs. Your mission is to define, prioritize, and drive the execution of a product roadmap that capitalizes on our Streaming Intelligence differentiator.

You will work closely with the CEO, the AI/ML, and Software Engineering teams to transform our advanced models into scalable enterprise solutions.

Product Strategy & Vision

• Own the Streaming Intelligence Vision: Define the long-term product strategy on Advanced Streaming Intelligence for speech, text, and visual input streams.
• Platform Roadmap Leadership: Develop and execute the product roadmap for the Intelligence-API and the Ambient-BOT platform components.
• Monetization & Market Expansion: Identify and prioritize the next categories of consumer and enterprise applications—from hyper-personalized search to audio-visual NPC controls—that can be enabled and monetized by our zero-wait technology.

Enterprise & Execution

• Drive Enterprise Deployment: Oversee the productization and successful deployment of the platform for major enterprise clients, directly contributing to company goals.
• Domain Adapter Strategy: Guide the development of domain adapters (e.g., HR, CX, e-commerce) to facilitate specialized enterprise use cases.
• Security & Compliance as a Feature: Ensure all products meet high standards for security, data privacy, and compliance (e.g., SOC2/HIPAA), productizing features like real-time redaction and non-storage of sensitive information transmission.

Leadership and GTM

• Guide the Part-Time PM: Work in partnership with the existing Product Manager to ensure tactical execution, including the launch of the Whissle App v1 and successful paid pilot programs.
• Market Leadership: Analyze competitor activities (e.g., turn-based systems like ChatGPT, Gemini, Perplexity) and use these insights to solidify Whissle's differentiated market positioning.

Qualifications

• 10+ Years of Product Leadership experience, with a proven track record of bringing highly technical B2B/Enterprise products to market.
• Deep Technical Expertise in AI/ML, particularly in the areas of speech, language processing, signal processing, or multi-modal AI.
• Exceptional Strategic Planning skills, with prior experience scaling a product which needs real-time intelligence, broad technology skills and experience.
• Strong Business Acumen in SaaS, enterprise licensing, and API revenue models.
• Bachelor's degree in Business, Computer Science, Engineering, or a related field; a Master's or PhD is a strong plus (especially given the team's academic background).
• Experience with building startups will be preferred

Compensation

We are on-boarding visionary leadership on equity basis before we raise suitable money from investors in the loop.

We are seeking a seasoned Technical Project Manager with 7+ years of experience leading complex, cross-functional IT initiatives within infrastructure and cybersecurity domains. This role will drive large-scale programs across enterprise infrastructure, cloud transformation, network modernization, identity & access management (IAM), and security operations.

The ideal candidate combines strong technical acumen with disciplined program governance, enabling the successful delivery of secure, scalable, and resilient enterprise solutions.

You will partner with Engineering, Security, IT Operations, Architecture, and Business stakeholders to lead end-to-end execution — from strategy and design through deployment and operational handoff — ensuring alignment to security standards, compliance requirements, and enterprise architecture principles.

Key Responsibilities

• Lead enterprise-scale infrastructure and cybersecurity programs across multiple geographies
• Drive end-to-end project lifecycle: intake, chartering, design reviews, risk assessment, implementation, and post-go-live stabilization
• Partner with Security (IAM, SOC, GRC), Cloud, Network, and Infrastructure teams to deliver secure and compliant solutions

Establish governance frameworks including:

• Project charters
• Risk registers
• RAID logs
• Milestone tracking
• Executive dashboards
• Manage cross-functional dependencies across IT, Security, Engineering, Legal, Compliance, and Business units
• Ensure alignment with enterprise security controls, regulatory requirements (e.g., SOX, GDPR, data protection policies), and audit readiness
• Drive SLA and KPI definition, tracking, and reporting
• Proactively identify risks and implement mitigation strategies to prevent security, operational, or compliance gaps
• Lead escalation management and executive-level communication
• Facilitate war rooms, incident coordination, and remediation tracking when required
• Ensure operational readiness including documentation, training, and transition to support teams

Required Qualifications

• 7+ years of experience managing IT infrastructure and/or cybersecurity programs
• Strong knowledge of enterprise infrastructure environments and cybersecurity including Cloud platforms (AWS/Azure/GCP), Network architecture (SD-WAN, firewalls, VPNs, segmentation), Identity & Access Management (Okta, SailPoint, AD), Cloud security posture improvements
• Strong understanding of SDLC and secure development practices
• Proven ability to manage large cross-functional teams across regions
• Experience defining and tracking KPIs, SLAs, and executive reporting metrics
• Strong risk management and issue resolution capabilities
• Ability to translate technical complexity into clear executive-level updates
• Experience with JIRA, Confluence, Smartsheet, ServiceNow, and Microsoft Suite
• Excellent written and verbal communication skills

Position Overview

The Water/Wastewater Estimator will be responsible for preparing accurate and competitive cost estimates for heavy civil infrastructure projects. This role requires strong analytical skills, in-depth knowledge of water and wastewater construction, and the ability to collaborate effectively with project managers, engineers, subcontractors, and suppliers.

Key Responsibilities

• Analyze plans, specifications, geotechnical reports, and contract documents for water and wastewater infrastructure projects
• Prepare detailed quantity takeoffs and cost estimates for treatment plants, pipelines, pump stations, and related facilities
• Solicit and evaluate subcontractor and supplier quotes
• Develop conceptual and hard-bid estimates
• Identify project risks and value engineering opportunities
• Participate in pre-bid meetings and site visits
• Maintain organized bid documentation and estimating databases
• Support project handoff to operations team upon award

Qualifications

• 5+ years of estimating experience in water/wastewater or heavy civil construction
• Strong knowledge of treatment plant construction, underground utilities, mechanical piping, and concrete structures
• Proficiency with estimating software (e.g., HCSS HeavyBid, Bluebeam, PlanSwift, or similar)
• Ability to read and interpret civil, structural, and mechanical drawings
• Strong Excel skills
• Excellent communication and organizational abilities
• Bachelor's degree in Construction Management, Civil Engineering, or related field preferred (or equivalent experience)

What We Offer

• Competitive salary based on experience
• Performance-based bonus opportunities
• Comprehensive health, dental, and vision insurance
• 401(k) with company match
• Paid time off and holidays
• Career growth opportunities within a rapidly expanding infrastructure market

Company Overview

Milestone Technologies is a global IT managed services firm that partners with organizations to scale their technology, infrastructure and services to drive specific business outcomes such as digital transformation, innovation, and operational agility. Milestone is focused on building an employee-first, performance-based culture and for over 25 years, we have a demonstrated history of supporting category-defining enterprise clients that are growing ahead of the market. The company specializes in providing solutions across Application Services and Consulting, Digital Product Engineering, Digital Workplace Services, Private Cloud Services, AI/Automation, and ServiceNow. Milestone culture is built to provide a collaborative, inclusive environment that supports employees and empowers them to reach their full potential.

Our seasoned professionals deliver services based on Milestone's best practices and service delivery framework. By leveraging our vast knowledge base to execute initiatives, we deliver both short-term and long-term value to our clients and apply continuous service improvement to deliver transformational benefits to IT. With Intelligent Automation, Milestone helps businesses further accelerate their IT transformation. The result is a sharper focus on business objectives and a dramatic improvement in employee productivity. Through our key technology partnerships and our people-first approach, Milestone continues to deliver industry-leading innovation to our clients. With more than 3,000 employees serving over 200 companies worldwide, we are following our mission of revolutionizing the way IT is deployed.

Job Overview

Company Overview:Milestone Technologies is a global IT managed services firm that partners with organizations to scale their technology, infrastructure and services to drive specific business outcomes such as digital transformation, innovation, and operational agility. Milestone is focused on building an employee-first, performance-based culture and for over 25 years, we have a demonstrated history of supporting category-defining enterprise clients that are growing ahead of the market. The company specializes in providing solutions across Application Services and Consulting, Digital Product Engineering, Digital Workplace Services, Private Cloud Services, AI/Automation, and ServiceNow. Milestone culture is built to provide a collaborative, inclusive environment that supports employees and empowers them to reach their full potential.

Our seasoned professionals deliver services based on Milestone's best practices and service delivery framework. By leveraging our vast knowledge base to execute initiatives, we deliver both short-term and long-term value to our clients and apply continuous service improvement to deliver transformational benefits to IT. With Intelligent Automation, Milestone helps businesses further accelerate their IT transformation. The result is a sharper focus on business objectives and a dramatic improvement in employee productivity. Through our key technology partnerships and our people-first approach, Milestone continues to deliver industry-leading innovation to our clients. With more than 3,000 employees serving over 200 companies worldwide, we are following our mission of revolutionizing the way IT is deployed.

Description:

The Access Management Specialist role is responsible for processing security and access permissions for various individuals requiring building access. They also serve as a customer service representative, assisting with access control requests and troubleshooting badge-related issues. Other responsibilities include managing inventory, generating reports, and assisting with alarm remediation.

Key Responsibilities:

• Lead day-to-day global badge operations management
• Hands-on operational involvement including processing Jira tickets, supporting new employee onboarding, and driving continuous program improvements
• Implement secure access zones and aide in the development of physical access infrastructure that supports identity management and RBAC/ABAC policies

Required Qualifications:

• Minimum of 1-3 years of experience in Security, Badging, Access Control fields.
• Proven experience with security access control systems (e.g., CCure, Kastle, Brivo, and property management access platforms)
• Strong background in access management within security operations
• Experience with Genetec is highly preferred

Work Schedule:

• Primary schedule: Monday through Friday 3pm-11pm
• Flexibility to provide support on weekends as business needs arise

Compensation

Estimated Pay Range: $30.35 - $42/hr

Exact compensation and offers of employment are dependent on circumstances of each case and will be determined based on job-related knowledge, skills, experience, licenses or certifications, and location.

Our Commitment to Diversity & Inclusion

At Milestone we strive to create a workplace that reflects the communities we serve and work with, where we all feel empowered to bring our full, authentic selves to work. We know creating a diverse and inclusive culture that champions equity and belonging is not only the right thing to do for our employees but is also critical to our continued success.

Milestone Technologies provides equal employment opportunity for all applicants and employees. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, gender, gender identity, marital status, age, disability, veteran status, sexual orientation, national origin, or any other category protected by applicable federal and state law, or local ordinance. Milestone also makes reasonable accommodations for disabled applicants and employees.

We welcome the unique background, culture, experiences, knowledge, innovation, self-expression and perspectives you can bring to our global community. Our recruitment team is looking forward to meeting you.

Position Title: Quality Manager

Immediate Supervisor: Executive Owner

General Purpose: This key leadership position is responsible for leading all aspects of Quality processes and systems, managing the Quality Management System (QMS), internal and external audits, regulatory and safety compliance, and leading a team of Quality Technicians, Process Engineers and Learning and Development Coordinators in a manufacturing environment. The role collaborates with cross-functional teams to drive continuous improvement, ensure product integrity, and exceed customer expectations. This role is with a small, family-owned contract manufacturing company that is rapidly expanding, fueled by New Product Introductions and the development of full-scale production capabilities.

Responsibilities:

QUALITY MANAGEMENT

Customer Response Team:

• Serve as the primary point of contact for quality-related communications with customers and suppliers.
• Manage customer complaints, lead investigations, and coordinate timely, effective resolution.

Manage ISO Certification

• Maintain the Quality Management System (QMS) in compliance with ISO 13485 and applicable customer/regulatory requirements.
• Own Document Control for QMS and production documents (Work Orders, labels, Certificates of Conformance, inspection forms), ensuring revision control, approvals, controlled release, and record retention.
• Lead internal and external audits (customer, supplier, registrar), including audit preparation, execution, follow-up, and reporting to the Executive Team.
• Own the metrology and test equipment program (calipers, gauges, vision systems, clean room monitoring equipment, etc.), including calibration/verification, status control, and records management.
• Oversee equipment qualifications and process validations to ensure ongoing compliance and product integrity.

Manage Quality Assurance Processes

• Drive robust Root Cause Analysis and CAPA execution for internal and external nonconformances.
• Lead and develop the Quality team, including supervision of Quality Technicians and daily quality execution on the production floor.
• Manage supplier quality performance, including supplier evaluations, audits, incoming quality issues, and nonconformance resolution.
• Maintain clean room quality standards, environmental controls, and monitoring/testing protocols.
• Assess quality organizational needs and build a high-performing team aligned with business growth and customer requirements.

CONTINUOUS IMPROVEMENT

• Lead and oversee the company’s Continuous Improvement (CI) program to drive process optimization, quality performance, and operational excellence.
• Partner cross-functionally to identify improvement opportunities, implement solutions, and sustain gains.
• Partner with company leadership to define quality strategy, establish KPIs, and drive continuous improvement.
• Evaluate and implement best practices, tools, technologies, and systems that strengthen quality, compliance, and manufacturing capability.
• Develop, maintain, and enforce manufacturing SOPs, work instructions, and standard work to ensure consistent execution and training alignment.
• Identify and mitigate operational risks affecting product quality, safety, delivery performance, and regulatory/customer compliance.
• Manage organizational safety programs, including compliance with the IIPP (Injury and Illness Prevention Program) and related safety requirements.

LEARNING AND DEVELOPMENT

• Lead and oversee company-wide training and employee development programs, including the implementation, development, and leadership of quality- and safety-related training, to support performance, compliance, and organizational capability, and ensure employees are competent to perform assigned duties and meet QMS requirements.
• Administer the Learning Management System (LMS), maintaining current training content, training matrices, and complete/accurate training records to support audits and continuous improvement.

Education / Experience:

• Bachelor’s degree in a quality, manufacturing, engineering, or medical device related field.
• 4+ years in a Quality leadership role within a manufacturing environment.
• 3+ years managing a QMS within ISO 13485 or other ISO Standards within a manufacturing environment, and leading customer/supplier audits.
• Proven experience with precision component manufacturing and contract manufacturing environments.
• Hands-on experience with CAPA, root cause investigations, and quality metrics.
• Familiarity with medical device manufacturing and regulated industries (Preferred).
• Familiarity with applying principles of Lean Manufacturing, Theory of Constraints and/or Six Sigma Problem Solving.

Qualifications:

• Proficient in interpreting engineering drawings and using inspection equipment.
• Strong organization and communication skills; experience delivering training.
• Comfortable working independently and leading small teams.
• Ability to effectively serve as the primary point of contact for all quality-related communications.
• Aptitude for working within a small family business environment where responsibilities and priorities can change quickly.
• Spanish-speaking ability (Preferred).
• Must be available for full-time, on-site work in San Carlos, CA.

Physical demands:

• Combination of office and plant production floor presence for supervision, inspections, and clean room management.
• Ability to sit at a desk for periods of time for planning and reporting.
• Ability to stand and walk for extended periods on the plant floor.
• Operate standard office equipment and hand controls.
• Ability to occasionally lift up to 20 pounds (e.g., supplies, production files).
• Observe visually distance, color, periphery and depth; ability to adjust focus.

What We Offer: 

• Full time permanent role with competitive salary and benefits (medical, dental, vision, 401(k) + matching)
• $110,000 - $140,000 per year
• Opportunity to grow within a technically advanced converting business working with top-tier customers and materials

**Disclaimer: This job description may not be inclusive of all assigned duties/responsibilities or aspects of the job, and additional duties/responsibilities may be assigned from time to time as necessitated by business demands and/or operational considerations at the sole discretion of the Employer. This job description does not constitute a contract of employment and the employment relationship between Employee and Employer is at-will.

We are hiring Full-Stack Enterprise AEs who can own the entire revenue cycle — from prospecting to closing and expansion.

This is not a traditional “wait for SDR handoff” role.

You will operate as a self-sufficient seller empowered with:

• FlashRev list-building
• AI SuperAgent
• Parallel Dialer
• AI Meeting Agent
• Automated workflows

Your Mission:

Land and expand 6–7 figure deals with U.S. and global enterprise customers.

You will sell FlashLabs’ AI GTM automation to:

• Fintechs (payments, wallets, neobanks)
• Insurtech
• Lending & BNPL platforms
• Brokerages & wealth tech
• Exchanges
• Compliance-driven fintech teams

Key Responsibilities

• Own the full sales cycle: from ICP targeting → outbound → qualification → demo → proposal → close → expansion.
• Conduct high-impact discovery with VPs, C-suite, and transformation teams.
• Deliver tailored demos of FlashLabs SuperAgent, FlashAI Voice, FlashRev, and AIFlow.
• Use our AI outbound engine + self-sourced pipeline to drive meetings.
• Conduct intelligent prospecting (email, LinkedIn, phone, AI agents).
• Build and maintain a strong top-of-funnel independently.
• Lead multi-threaded enterprise sales cycles (6–12 weeks).
• Handle InfoSec, legal, procurement, and compliance reviews.
• Build ROI, business cases, and transformation proposals.
• Drive land-and-expand motions across teams, departments, and regions.
• Partner with CS to ensure adoption and value realization.
• Grow accounts into multi-year, high-ACV partnerships.
• Become a domain expert in AI GTM automation.
• Relay product feedback to engineering to guide the roadmap.
• Represent FlashLabs at industry events, webinars, and executive briefings.

THE OPPORTUNITY

The Senior Director of Quality Assurance and Regulatory Affairs is a critical member of the leadership team, responsible for establishing and leading the company’s quality and regulatory function, as well as the champion for Moximed’s total quality management system for orthopedic implants and single-use instruments.

This leader oversees all aspects of quality assurance, quality control, regulatory affairs, compliance, and post-market surveillance. They will also guide the regulatory strategy needed to support current commercial products and future pipeline innovations in conjunction with senior management.

The Senior Director will define organizational structure, hire key roles, and foster talent development within the QA and RA department to help ensure successful completion of projects and company milestones in close collaboration with Research and Development, Operations, Sales, Marketing and Clinical Affairs.

This role includes being the Regulatory Affairs team representative for interactions with regulatory bodies, primarily the US FDA and as such will oversee activities related to submissions, registrations and listings, and Medical Device Reporting in cooperation with multiple departments.

WHAT YOU'LL DO

Quality Assurance:

• Provide leadership to the existing Quality Assurance team including managers and individual contributors.
• Assume primary responsibility for implementation and maintenance of all aspects of the company-wide quality management system. Determine and enforce (through functional groups) quality requirements in accordance with FDA QMSR and ISO standards.
• Lead preparation and planning for quality programs to support commercial activities and ongoing compliance, including complaint tracking, investigation, trending and reporting program.
• Direct quality program development with multiple functions (Operations, R&D, Sales & Marketing, external vendors) to assure adequate resources are available to meet project timelines.
• Organize and promote company-wide quality improvement efforts, including setting annual quality objectives.
• Hire, train, and manage QA Staff.
• Advise and consult with internal staff and scientific consultants who contribute to regulatory submissions, ensuring that appropriate information complies with regulatory regulations/standards/guidelines.
• Direct implementation and ongoing management of international complaint handling system; in compliance with FDA MDR and device vigilance reporting regulations.
• Act as or designate QA representative on product development teams (design control and risk management); critically review all documentation for submissions for consistency, accuracy and quality.
• Supervise and provide guidance on day-to-day quality activities including supplier quality/incoming inspection, management review, training, document control, non-conforming material, and corrective and preventive action.
• Supervise and manage internal audits and inspections including FDA, Cal FDB and others.
• Review Change Orders, Design Change Notices, etc., for compliance with FDA, and international regulations and standards.
• Monitor proposed changes in regulations, standards and guidance publications for impact on current and future development strategies.

Regulatory Affairs:

• Lead and develop a Regulatory Affairs team consisting of external and internal resources.
• Oversee the company’s regulatory filings including IDEs, supplements and amendments, Post marketing studies and reports, marketing submissions including De Novo and 510(k) and ongoing updates and annual/periodic reports for all company submissions.
• Organize and lead projects and subprojects related to RA strategies. May enlist external experts and other resources and manage related actions.
• Responsible for developing and maintaining regulatory affairs operating procedures and work instructions.
• Lead and/or oversee regulatory activities by reviewing study-related documents in accordance with applicable regulations.
• Work with external and internal resources for input and ideas for regulatory strategy to address FDA questions and planning for data framing to highlight Moximed technology advantages and context for risk.
• Act as or designate ‘Responsible Party’ for purposes of submitting information about Moximed’s applicable clinical trials (ACT) on in coordination with the Clinical Affairs department.
• Ensure the uniform and timely processing of Moximed Medical Device Reports (MDRs) in accordance with FDA regulations and internal operating procedures.
• Support product development/improvement projects with R&D and Engineering to assure applicable regulatory requirements are met.
• Provide regulatory strategy guidance to clinical and operations departments.
• Lead ad/promo review of product labeling, literature and company websites for accuracy, consistency and domestic and international regulatory compliance.
• Lead activities for State and Federal regulatory licenses, registrations and listings.
• Responsible for obtaining and maintaining FDA Small Business Designation.
• Support review of internal operating procedures and other controlled documents to ensure regulatory and quality compliance and consistency with regulatory commitments.
• Research, prepare and communicate new and changing product regulatory assessments and justifications.
• Assist with the training and development of personnel on Regulatory requirements.
• Support the Complaint Handling Unit, particularly with timely regulatory assessments of complaints for reportability determination for any adverse event or malfunction.

ABOUT YOU

• Bachelor’s or advanced degree preferred in Life Sciences, engineering or other technical discipline or other equivalent job experience.
• 15+ years of progressive experience in medical device quality assurance and/or regulatory affairs roles. Prior orthopedic medical device experience or experience with Class II/III implantable devices is a plus.
• Minimum of 12 years of progressive managerial experience successfully managing technical personnel and complex activities as required.
• Demonstrated strong leadership presence with ability to collaborate cross-functionally and build high-performing teams.
• Excellent working knowledge of FDA and international regulatory requirements and standards required. Experience with preparing international submissions/registrations required.
• Organize and lead teams and sub-teams to address complex quality and regulatory strategies in a growth-stage environment.
• Demonstrates strong organizational skills and the ability to collect and assess data, establish facts and report on findings.
• Demonstrates the highest levels of integrity, and good interpersonal and presentation skills.
• Have a working knowledge of ISO13485, 21 CFR820, preferred knowledge of MDR.
• Possess leadership qualities and be a great team player; possess the ability to communicate clearly and effectively, both orally and in writing; demonstrate capacity to calmly, clearly and consistently communicate regulations to technical functions within the company; possess the ability to handle multiple tasks, and the ability to think strategically while attending appropriately to details.
• Must be able to read, analyze, interpret and assist in the creation and refinement of company procedures; demonstrate the ability to define problems, collect data, establish facts, draw valid conclusions and report on findings. The candidate must be able to demonstrate the highest level of integrity, excellent negotiation skills, and excellent interpersonal and presentation skills.
• Strong work ethic.

At Moximed we believe that the unique contributions of all our team members create our success. To ensure that our culture continues to incorporate everyone’s perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, marital, veteran, or disability status

Pay Transparency:

Moximed offers a comprehensive benefits package including competitive pay, health insurance, Disability Insurance, 401K, paid time off plus holidays, and a flexible approach to work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.

California Pay Range: $160K-$220K