Engineering Jobs in Santa Rosa, CA
123 positions found — Page 5
Heavy Civil Estimator
When joining GSW Construction, Inc., you will be a part of a fast-paced construction team that strives for excellence. We are actively seeking an experienced Heavy Civil Estimator. The purpose of this role is to contribute to the success and profitability of projects by providing accurate, timely, and complete estimates. The Estimator will be responsible for calculating the cost of a broad range of projects. The goal is to provide accurate information to help in operations and strategic planning, perform quantity takeoff s, produce proposals, and prepare cost estimates.
Job Details: Full-time position
● Benefits: o Salary Employee (Schedule: Full-time with some required travel and weekend availability.) o 401(k) o OE3 Health & Dental Insurance o Paid Vacation o Salary DOE Essential Duties & Responsibilities
● Perform quantity take off s/reach out to potential subcontractors
● Analyze and compile estimate data that impact the cost of labor, materials, equipment requirements, location, and other factors to ensure a high-quality and timely estimate.
● Accurately prepares estimates. Review proposal specifications and drawings to determine scope. Determines the required contents of estimates and evaluates historical data to project man-hour data.
• Produce budgets from conceptual and schematic design phases that align with the organization's goals and strategy • Review drawings, specifications, and proposed project site conditions; record findings and solicit input from field operations to include in the final project estimate.
● Analyze alternative solutions and construction methods to increase the competitiveness of the bid.
● Apply mathematical calculations requiring advanced analytical processes to ensure logically estimated costs are accurate.
● Present estimate content in bid reviews with senior management to ensure accuracy and completeness. ● Communicate with owners, subcontractors, and public and private entities to ensure competitiveness.
● Develop and maintain business relationships to increase bid opportunities in the regional market.
● Participate in and lead discussions, catalyzing creative thinking and innovative ideas, and distinguishing a successful estimate.
Qualifications & Requirements
● Bachelor’s degree in civil engineering, Construction Management, or equivalent experience.
● 5+ years’ experience in heavy civil construction, emphasizing underground utilities, sewer/stormwater pump stations, WWTP/WTP work, heavy highway, bridges/concrete structures, and commercial/residential site work arena.
● Proficient in HCSS Heavy Bid
● Negotiated project experience preferred, including technical writing skills.
● Proficiency with all MS Office products (Word, Excel, PowerPoint, etc.)
● Advanced knowledge of civil engineering principles ● Advanced knowledge of construction principles and equipment capabilities
● Excellent interpersonal and communication skills. Specific Job Requirements:
● Knowledge of project management software and estimating software.
● Working knowledge of construction equipment, materials, techniques, and required standards applicable to the discipline.
● Successful completion of a pre-employment drug, alcohol, and background investigation.
● Valid Driver’s License.
● Current on all company-required safety training.
● Competence to maintain confidential information and avoid conflicts of interest.
● Adherence to the GSW Employee Handbook.
Notice to All Potential Job Candidates GSW Construction, Inc. is proud to be an equal-opportunity workplace. Individuals seeking employment at our company are considered without regard to age, ancestry, color, race, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, sexual orientation, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, religion, military or veteran status, or any other characteristic protected by federal, state, or local laws. Applicants must be authorized to work in the United States.
The Senior Estimator responsible for preparing budgets, estimates and pre- bid packages for construction projects to be built for clients under the CM at Risk guaranteed maximum pricing structure.
Responsibilities also include working with the project management team in establishing a bidders list, soliciting and evaluating subcontractor proposals and scopes of work, preparing quantity surveys and reviewing project plans and specifications for constructability and value engineering in all CSI (Construction Specification Institute) categories of work.
The Senior Estimator will supervise a team of estimators and cost engineers who support departmental and organizational goals through their efforts.
Responsibilities includes (but may not be limited to):
- Performs accurate, thorough and timely quantity takeoffs using company format, detail and coding for all MasterFormat (CSI), Uniformat and bid packages for all levels of project documents (schematic, design development and construction documents) that can be clearly understood by internal and external team members.
- Assist in developing estimates by evaluating drawings, building plans, specifications, & related documents.
- Assists in providing quantity comparison between estimate revisions.
- Prepares detailed estimate.
- Actively participates in the internal estimate review process.
- Develops accurate and concise clarifications and assumptions with the project management team’s assistance.
- Assists with final assembly of estimate for presentation to owner.
- Summarize estimate data into reports for review by executive team, clients, and design teams.
- Prepares and presents budget presentations to owners and architects.
- Leads the buyout process.
- Prepare detailed instructions to bidders, trade specific scope of work and comprehensive bid packages.
- Directs, coordinates and provides information and documents to subcontractors.
- Assist with pre-bid site walks and document existing conditions.
- Assist with subcontractor bid review and ensure scope of work is comprehensive.
- Prepare bid tallies for project team and owner review.
- Leads in the technical review of plans and specifications during the schematic design, design development and construction document phases of pre-construction.
- Assist with reviews of milestone documents to identify and communicate the development of changes to the team.
- Obtains clarification on plans and specifications from architects and engineers when necessary.
- Conducts reviews of milestone documents to identify and communicate the development of changes to the team.
- Communicates with architects and consultants to clarify scope of work, materials, and schedule requirements, and documents these clarifications.
- Demonstrate strong communication skills internally with project management team, and externally with owner, architect, engineer, and subcontractors.
- Manage individual workload to accomplish tasks within given timeframes.
- Manage other team members’ workloads to accomplish tasks within given timeframes.
- Ability to perform duties across multiple projects concurrently.
- Considers and understands problems and identifies appropriate solutions.
- Builds and maintains effective relationships with customers, design team, subcontractors, suppliers and user groups that reflect and support company core values and meets customer’s expectations.
- Attends project site pre-bid meetings, site tours and post-bid interviews as required.
- Assist and participate with pursuit interview prep and presentations.
- Develops unit costs accurately and analyzes value management analysis options.
- Develops Cost Management / Value Engineering log process and manages during the preconstruction process.
- Develops Variance Reports at milestone issuances that clearly define deltas between estimates for internal and external use.
- Develop Cost Studies in clear and concise platform for project team review and decision making.
- Develop Benchmark studies for project estimate comparison for internal review and analysis.
- Self-reliant in researching, understanding, and developing knowledge of building designs, systems, construction materials, and methods through available resources.
- Ability to teach, educate, and guide both internal and external team members.
- Provides internal database input based on current market feedback for incorporation into database.
- Leads in the training and development of cost engineers.
- Leads in the training and development of estimators.
- Provide feedback to estimate team members on work process / work product on a regular basis.
- Works closely with new hires and/or new project teams to educate them on the way of doing business based on standard forms, programs and operational standards.
- Oversees the preconstruction process with the owner’s team.
- Provides support as needed to the project management teams as needed.
- Creates projected budgets early in the design phase of a project.
- Coordinates preconstruction planning with design team, contractors and clients.
- As necessary, works with Executive Group on special initiatives, company goals and associate related training and/or programs.
- Provides input on future projects via lessons learned and continuous improvement.
- Attends project meetings with clients, the city and design team.
- Works with development or owner to coordinate the design and specifications on issues.
- Leads the pre-construction team to ensure initial budgeting represents current market pricing and quality reporting.
- Communicates with project management team, ownership, clients, subcontractors, vendors, etc. to provide quality results while mitigating project risks.
- Collaborates with VP’s towards a common goal; streamline the project delivery process, review progress of buy- out, submittals, construction schedule and performance on all projects.
- Keeps current with latest estimating technology and techniques.
- Manages project budgets for preconstruction services.
- Manage time and utilize electronic timecard software in a timely manner.
- Other duties upon request.
Qualifications:
- 10+ years of experience as Estimator / Sr. Estimator in commercial construction industry
- Bachelor’s degree in Construction Management, Construction Science, or Civil Engineering preferred but not required
- General Construction Knowledge
- Knowledgeable in civil/site construction, foundation and structural systems, interior finishes, exterior wall systems, mechanical and electrical systems and the costs of these systems
- Ability to read and interpret drawings and specifications
- General knowledge of negotiated bids, hard bids, and GMP processes
- Proficient in all estimating software programs used in preconstruction: On-Screen Takeoff (OST), Destini, Timberline, Building Connected, Assemble, Bluebeam, Power BI, BIM360, Excel, Word, MS Project
- Must possess strong verbal and written communication skills
- Strong math and analytical skills
- Attention to detail
- Organized, efficient, able to multi-task effectively, hardworking, and dedicated
- Able to thrive in a deadline-oriented, fast-paced environment
- Excellent communication skills and interpersonal skills
- Demonstrated analytical, problem solving, and both oral and written communication skills
- Enjoys being part of a collaborative team and a fun work environment
- Possess the ability to estimate all aspects of a commercial construction project, assemble into one budget and present to owners
- Must be able to operate as a “stand alone” estimator able to handle complete projects if required
- Ability to manage personnel, subcontractors, preconstruction schedules and preconstruction budgets
- Ability to mentor and coach personnel
Working Conditions:
- Duties required physical abilities such as repetitive hand and finger motion, sitting, standing, walking, as well as extending hands and arms in work areas.
- The individual is required to occasionally move around the office and constantly operate a computer and other office machinery, etc.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions.
ProcureAbility, a Jabil company, is the leading procurement services company, offering advisory, managed services, digital, staffing, and recruiting solutions. For 30 years, we have focused exclusively on helping clients elevate their procurement function. We combine leading methodologies, analytics, market intelligence, and industry benchmarks with our uniquely flexible and customizable service delivery model. Global organizations of all sizes trust ProcureAbility to transform their procurement operations, drive growth, and reimagine what’s possible.
Job Title: Sourcing and Contract Specialist
Our client, a leader in their industry, is hiring Sourcing and Contract Specialists. These are contract roles, currently scheduled through 12/31/26 with potential to convert to direct hire.
Hybrid Role: Training will be on-site for 2 weeks, and then the role will be hybrid. After the training period, the work is expected to be mainly remote with occasional on-site meetings.
Location: East San Francisco Bay area
Job Category: Procurement / Supply Chain
Job Level: Individual Contributor
Applicants must be authorized to work for ANY employer in the U.S. ProcureAbility is unable to sponsor or take over sponsorship of an employment Visa at this time.
What can you expect to do?
Responsibilities:
• Conducts negotiations with bidders, for non-routine, may support or work with Sourcing.
• Coordinates and assembles supporting documentation to support audits.
• Works with vendors and internal stakeholders to assemble, review, prepare, and route for vendor and management approval (using ARIBA and EDRS), necessary documents for these tasks.
• Works with vendors, Project Team to improve quality of supporting contract documents to reduce rework required by others.
• May assist in the creation and development of purchase requisitions.
• For Routine Contracts, reviews vendor proposals to ensure that rates and terms are consistent with outline agreements.
• May support / review vendor proposals to ensure that rates and terms are consistent with outline agreements.
• Ensures that Company standards are followed when executing contract documents.
• Tracks approval status of contracting documents from inception through approval and ensures that documents are routed expeditiously.
• For Routine Contracts, conducts negotiations with bidders, for non-routine, may support or work with Sourcing department.
• Reviews purchase orders and contracts as part of procurement approval process.
• Provides technical support and analysis in preparation of scope, cost, schedule, safety and environmental concerns pertinent to the contract specifications; and verify and process contract invoices.
What is needed to be successful in this role?
• Bachelor’s Degree in Construction Management, Engineering, Business Administration or related field
• Ability to work in cross-functional teams
• Ability to work in a team environment
• Ability to work on multiple issues and tasks
• Advanced in MS Excel, PowerPoint
• Demonstrated competencies on use of supply chain management tool (e.g. ARIBA) and other business systems tools (SAP, SharePoint, EDRS)
• Demonstrated knowledge of Company standards regarding contracting processes.
• Conflict resolution/negotiation skills
• Demonstrated ability to track contract costs, purchase order status, and other required information in SAP
• Demonstrated competencies on use of ARIBA and EDRS is a plus
• Process improvement experience
• Presentation Skills
• Verbal and Written Communication Skills
• Knowledge of Contractual Terms and Conditions
ProcureAbility, A Jabil Company, is proud to be an Equal Employment Opportunity and Affirmative Action Employer. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as a person with a disability, or other legally protected characteristics.
If you are a Qualified Person with a Disability or a Disabled Veteran and require assistance making your application, please get in touch with HR at
Don’t meet every single requirement? Studies have shown that women and people of color are less likely to apply for jobs unless they meet every qualification. At ProcureAbility, we are dedicated to building a diverse, inclusive, and authentic workplace, so if you’re excited about this role but your experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyway. You may be just the right candidate for this or other roles.
A fast-growing robotics company is building autonomous systems designed to automate repetitive tasks within the global infrastructure and construction sector. The company’s mission is to help address workforce shortages while accelerating the development of critical infrastructure projects.
Their robotics platforms combine advanced autonomous navigation, cloud software, and intelligent field tools to improve precision and efficiency across construction environments. With a growing fleet of robots already deployed across multiple project sites globally, the company is developing the next generation of automation tools used in areas such as infrastructure development, surveying, energy projects, and large-scale construction.
The company is seeking a Full-stack Developer to design and maintain the software systems that power its robotics ecosystem — including operator dashboards, cloud infrastructure, and applications that interface with robots operating in the field.
This role will contribute to building reliable tools for mission planning, fleet monitoring, and communication between cloud systems and robotic platforms. The position involves close collaboration with robotics engineers, field operations teams, and product stakeholders to ensure the software delivers measurable impact in real-world environments.
Key Responsibilities
- Design and develop full-stack applications for device management, mission control, and fleet coordination.
- Build and maintain mobile applications used by field operators.
- Develop desktop applications used to interface with robotic systems.
- Create web dashboards and APIs for mission planning, telemetry visualization, and operational data analysis.
- Integrate cloud infrastructure for data storage, monitoring, and deployment.
- Ensure reliable communication between cloud services and deployed robotic systems.
- Collaborate with robotics, product, and field teams to deliver integrated software functionality.
- Write technical documentation for APIs, system architecture, and software modules.
- Optimize systems for scalability, reliability, and performance in field environments.
- Requirements
- Education
- Bachelor’s or Master’s degree in Computer Science, Software Engineering, or a related field.
Experience
- 4+ years of professional full-stack development experience.
- Strong experience with JavaScript / TypeScript using modern frameworks such as React, Next.js, and Node.js.
- Strong UI/UX development experience using modern CSS frameworks.
- Experience building mobile applications using React Native.
- Experience developing cross-platform desktop applications.
- Production experience with cloud platforms such as AWS including APIs, storage, and deployment pipelines.
- Strong understanding of software architecture, testing methodologies, and performance optimization.
- Proficiency with development tools including Git, issue tracking systems, and CI/CD pipelines.
Soft Skills
- Strong analytical and problem-solving ability.
- Ability to collaborate effectively in a fast-paced engineering environment.
- Strong ownership mindset and communication skills.
- Preferred Qualifications
- Experience working with robotics systems or robotics middleware.
- Familiarity with real-time communication protocols such as WebSockets or MQTT.
- Experience working with IoT devices, connected hardware, or industrial systems.
- Experience working with performance-sensitive or multi-threaded applications.
- Experience with containerization technologies such as Docker or Kubernetes.
About the Company
Atomus’ mission is to provide world-class cybersecurity for the world’s most critical organizations. We build security compliance software delivered as managed services sold directly, with relevant professional services and support. Our commercial customers include hypersonic aircraft companies, satellite and space mission systems companies, AI and software companies, among many others serving primarily the aerospace and defense industry. At Atomus we are hardworking, we move fast, and we put our customers first.
About the Role
As a Business Operations Intern, you’ll play a key role in keeping our fast-moving team running smoothly—from coordinating product shipments and managing our Shopify store to planning team events and supporting the cofounders on strategic projects. We’re looking for someone who moves quickly, leans on AI tools to work smarter, and has a sharp eye for design and detail. This is a hands-on role where you’ll gain real experience across every facet of a growing cybersecurity startup.
Responsibilities
- Coordinate and manage physical shipments of security products to customers, including tracking orders, preparing packages, and communicating delivery timelines
- Help manage and maintain the company’s Shopify store, including inventory tracking, product listings, and order fulfillment
- Plan and coordinate team events and travel logistics
- Support the cofounders on a variety of strategic and operational projects as priorities evolve
- Manage office supply and snack ordering to keep the team well-stocked and happy
- Leverage AI tools and agents (e.g., Claude, ChatGPT, automation platforms) to streamline workflows and increase efficiency across tasks
Qualifications
- Currently enrolled in a Bachelor’s or Associate’s degree program at a Bay Area college or university, ideally pursuing a technical degree (e.g., Computer Science, Engineering, Information Systems, Business Analytics)
- Demonstrated proficiency with AI tools and a strong preference for using AI agents (e.g., Claude, Lovable) to get work done faster
- A good eye for design—whether it’s formatting a document, laying out a slide deck, or organizing a storefront
- Strong organizational skills and attention to detail
- Excellent written and verbal communication skills
- Comfortable managing logistics and coordinating shipments or deliveries
- Thrives in a fast-paced environment and can juggle multiple priorities with minimal direction
- Reliable, self-motivated, and able to work independently
- Ability to work in-office in downtown San Francisco 10–20 hours per week
Preferred Skills
- Interest in cybersecurity, technology, or the startup ecosystem
- Experience with Lovable or similar AI-powered app building tools
- Experience with Shopify or other e-commerce platforms
- Experience coordinating events, travel, or conference logistics
- Previous experience with shipping, logistics, or inventory management
- Familiarity with project management tools (e.g., Asana, Trello, Notion)
- Familiarity with design tools (e.g., Canva, Figma) for light creative tasks
- Previous internship or work experience in an office or operations role
Pay range and compensation package
Competitive hourly pay. Flexible scheduling around your class schedule (10–20 hours/week). Mentorship and hands-on exposure to multiple areas of a growing cybersecurity company. A collaborative, supportive team culture in a downtown San Francisco office.
Technical Designer, Furniture
SAUSALITO, CA
Serena & Lily is seeking a Technical Furniture Designer to join our Design Team. The ideal candidate will be responsible for the technical development process of all furniture categories. This role involves ensuring that quality, accuracy and on time execution in a cost-effective manner of all furniture projects from concept to production, are met while maintaining brand integrity. This position reports directly to CDO.
RESPONSIBILITIES:
- Translate design direction from CDO into detailed technical specs with accurate renderings to illustrate concept ideals.
- Develop and implement product development strategies aligned with company goals and market trends.
- Identify opportunities for innovation in furniture production, materials, and production processes.
Project Management
- Translate design direction from CDO into detailed technical specs with accurate renderings to illustrate concept ideals.
- Oversee the product development lifecycle, from initial renderings to cads, to sample and swatch reviews.
- Clearly communicate to agents and vendors calls outs and comments in a timely manner.
- Develop new finishes and color panels and ensure consistency through production.
- Ensure projects are delivered on time, within budget, and meet quality standards.
- Own the sharing of information in weekly PD meetings.
- Keep all documents and shared tools current and up to date.
- Maintain and organize swatch libraries.
- Cad all cushions where applicable and all outdoor covers for outdoor collections.
- Confirm PI sheets are accurate.
- Review and comment on furniture renewal swatches in a timely manner.
Quality & Compliance
- Establish and maintain quality assurance protocols throughout the product development process.
- Ensure all products meet regulatory and safety standards for target markets.
- Address and resolve product issues promptly and effectively.
Key Personal Attributes
- Strategic thinking and ability to align product development with business goals.
- Strong problem-solving skills and adaptability in a dynamic environment.
- Attention to detail and commitment to quality.
- Collaborative mindset with the ability to develop strong cross functional and respectful relationships.
- Strong work ethic with an ability to turn on a dime.
- Be part of a small tight knit team with a desire to jump in where needed to assist in department projects.
QUALIFICATIONS:
- Bachelor’s degree in industrial design, Product Development, Engineering, or related field.
- 5+ years of experience in furniture product development.
- Strong knowledge of furniture design, materials, manufacturing processes, and industry standards.
- Proven track record of managing multiple complex product development projects.
- Excellent leadership, communication, and interpersonal skills.
- A high level of proficiency in design software (e.g., AutoCAD, SolidWorks) and project management tools.
- Experience with sustainability practices in furniture design is a plus.
COMPENSATION:
- $100-130k per year is the anticipated starting base pay for this role. This range represents the low and high end of the anticipated base salary range for this role. The actual base pay is dependent upon many factors, such as: experience, education, and skills.
- Employees (and their families) are covered by medical, dental, vision, and basic life insurance should they choose to participate in Serena & Lily’s benefits. Employees can enroll in our company’s 401k plan. During the first year of employment, full-time employees accrue twenty-one days of PTO and seven paid holidays throughout the year.
Manufacturing Technician - Machine Assembly & Test
Contract
Fremont, CA (Onsite)
This position pays around $28/hr - $32/hr on W2
Job Summary
The Manufacturing Technician will be responsible for the hands-on assembly, testing, and troubleshooting of their production systems. This role will involve working closely with engineers and other technicians to ensure the quality and performance of our machines. The ideal candidate possesses a strong mechanical aptitude, experience with assembly and testing processes, and a commitment to quality and safety.
Responsibilities
- Assemble complex mechanical and electromechanical systems according to work instructions and engineering drawings.
- Perform functional testing of assembled systems, including data collection and analysis.
- Troubleshoot and diagnose mechanical and electrical issues.
- Use hand tools, power tools, and precision measuring instruments to assemble and test equipment.
- Read and interpret schematics, wiring diagrams, and assembly drawings.
- Follow standard operating procedures (SOPs) and safety guidelines.
- Maintain a clean and organized work area.
- Collaborate with engineers and other technicians to improve assembly and test processes.
- Document assembly and test results accurately.
- Identify and report any quality issues or discrepancies.
- Assist with the installation and commissioning of new equipment.
- Contribute to a positive and collaborative team environment.
Qualifications
- High school diploma or equivalent; technical certification or associate's degree in a related field is a plus.
- 2+ years of relevant experience in manufacturing or a related field, preferably with experience in machine assembly and testing.
- Strong mechanical aptitude and hands-on skills.
- Experience with using hand tools, power tools, and precision measuring instruments (e.g., calipers, micrometers).
- Ability to read and interpret schematics, wiring diagrams, and assembly drawings.
- Familiarity with basic electrical and mechanical principles.
- Excellent problem-solving and troubleshooting skills.
- Ability to work independently and as part of a team.
- Strong attention to detail and commitment to quality.
- Good communication and interpersonal skills.
- Experience with data collection and analysis is a plus.
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
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
Our client is looking for an IP Litigation Associate with 3 to 5 years of AMLAW 200 experience for their very sophisticated practice group. The firm is looking for those that have backgrounds in Electrical Engineering or Computer Science from top schools for this above market to market salary opportunity in any of their 3 locations: Washington D.C., New York or San Francisco. This is a fantastic opportunity to work with a close-knit group that offers no billable hour requirements and the ability to work on some of the most important intellectual property disputes in recent times. If you or someone you know meet these requirements, please message me today. I would LOVE to chat!