Jobs in Kenwood, CA

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.

QA Program Manager – GCP / GLP / GVP

We are partnered with a well established Medical Device company looking to expand their Quality Assurance team.

They are seeking an experienced QA Program Manager, this individual will support the embedded Quality leadership across clinical, nonclinical, and pharmacovigilance programs from early through late-stage development.

Key Responsibilities

• Lead and conduct GCP, GLP, and GVP audits
• Provide hands-on QA support across study planning, execution, and close-out
• Drive inspection readiness and support global regulatory inspections (FDA, EMA, ICH)
• Lead deviation investigations, root cause analyses, and CAPA implementation
• Oversee and qualify external vendors to ensure ongoing compliance

Profile

• 7+ years’ QA experience in pharma, biotech, or medical device
• Strong background supporting clinical, nonclinical, and PV activities
• Proven audit leadership and regulatory inspection support
• Experience in imaging agents, diagnostics, or combination products preferred

Seeking a west coast P&C Account Executive for a national private equity-M&A practice for a top 5 broker in the world.

The primary role of the Account Executive is responsibility for placement and client management on an assigned book of business, as well as guiding the Service team.

The AE is responsible for a more complex book of business, based on industry specialty, account revenue size and/or coverage complexity, such as loss sensitive programs, large deductibles, captives or shared and layered programs.

Overview

Whistler Partners is partnering with a nationally recognized technology and life sciences law firm seeking a mid-level associate (3+ years) to join its world-class Technology Transactions practice.

This team handles complex, cutting-edge technology transactions for some of the most prominent technology, digital media, and consumer tech companies in the United States and internationally — from early-stage innovators to publicly traded market leaders.

The practice works closely with one of the top-ranked startup, IPO, and M&A corporate platforms in the country, offering associates meaningful exposure to the intellectual property and commercial aspects of transformative deals.

Why this role?

At the Center of Innovation

You’ll advise emerging and established technology companies on mission-critical commercial agreements, licensing arrangements, and strategic transactions involving high-value IP and data assets.

True Deal Adjacency

This practice works hand-in-hand with corporate teams on M&A, IPOs, and other major transactions. You’ll counsel on the intellectual property and commercial components of deals — not just standalone contracts.

Breadth Across Growth Stages

From startup technology companies to public enterprises, you’ll gain exposure across the full company lifecycle.

Platform Strength + Optionality

This is a nationally recognized tech transactions group within a broader firm known for its dominance in startup and life sciences work — a powerful foundation whether your long-term goal is partnership or in-house leadership.

Key Responsibilities

• Draft and negotiate complex commercial and technology agreements
• Advise on software licensing, IP commercialization, SaaS, data rights, and platform agreements
• Support M&A and other corporate transactions on IP and commercial diligence and structuring
• Counsel clients on contract and intellectual property strategy
• Work closely with corporate teams advising startup, growth-stage, and public companies

Ideal Candidate Profile

• 3+ years of substantial law firm experience in technology transactions
• Strong grounding in intellectual property and contract law
• Experience handling complex commercial agreements for technology companies
• Exposure to IP and commercial aspects of M&A or other corporate transactions
• Superior academic credentials
• Excellent drafting, communication, and interpersonal skills
• Barred in the jurisdiction of application or eligible to waive/sit for the next exam

Locations

Boston, New York, Silicon Valley, San Francisco, or Santa Monica.

About Whistler Partners

Matchmakers, Not Headhunters

Whistler Partners is a boutique matchmaking firm focused on counseling the best and the brightest attorneys over the course of their careers. We believe that the right move comes from working closely with talent to curate their long-term career paths. When it comes to career advice, what matters is not the size of the agency but the strength of your individual recruiter.

We readily admit that we are elite and only work with the best – after all, a little elitism is okay when it comes to your career. Employers love us because we are picky about whom we represent, and attorneys love us because we get them their dream jobs.

Client: Medical Device

Details:

• 6-Month contract with high potential of conversion
• 40-Hours per week, on-site in SSF

Requirements:

• 6+ years of experience in the medical device industry with at least 3 years of experience in a management, supervisory or lead role
• Experience in building a production team and overseeing assembly team schedule
• Hands-on experience with assembly, testing, or packaging of electromechanical or disposable medical devices

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!

Company Description

US ENT Partners helps ear, nose, and throat (ENT) practices achieve cost savings by aggregating purchasing volume to negotiate maximum discounts with manufacturers, distributors, and suppliers.

Role Description

This full-time Customer Success Associate role is located in the San Francisco Bay Area with a hybrid work model (3 days a week in office). The Associate will handle tasks such as data collection, analysis, interpretation, and communicate findings to stakeholders. This role will contribute to vendor alignment, performance tracking, and the development of actionable insights that support our member practices and internal strategic initiatives.

Qualifications

• Bachelor’s degree in Business, Healthcare Administration, Finance, Analytics, or related field
• 2–4 years of experience in a healthcare, operations, analytics, or consulting environment
• Strong Excel and data visualization skills (Power BI, Tableau, or similar)
• Familiarity with healthcare supply chain, group purchasing, or provider operations preferred
• Strong attention to detail, project management skills, and ability to meet deadlines
• Excellent written and verbal communication skills
• Self-starter with the ability to thrive in a fast-paced, hybrid team environment

OTE: 80-100k

Why US ENT?

Joining our team means being part of a dynamic organization that values data-driven decision-making and continuous improvement. We offer a collaborative work environment, opportunities for professional growth, and the chance to make a meaningful impact in the healthcare industry.

Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits to reach previously undruggable patient populations. Founded by pioneers in the CRISPR field from leading institutions for gene editing research, the company is developing a first-of-its-kind RNA editing platform that can correct thousands of bases at once, thereby correcting genetic mutations safely and reversibly. Multiple openings are available on a rapidly growing team. If you are interested in building a new frontier in genetic medicine, please apply via LinkedIn.

Job Description: Associate Director or Director, Nonclinical Development

Position Overview:

We are seeking an experienced and highly motivated Director of Nonclinical Development to lead preclinical activities supporting our RNA editing pipeline. The successful candidate will design and oversee nonclinical pharmacology, biodistribution, and toxicology studies, ensuring timely and high-quality execution to support IND submissions. Reporting into the VP of Development, the candidate will provide both strategic leadership and hands-on management in a fast-paced startup environment, partnering closely with discovery, analytical, and manufacturing teams.

Key Responsibilities:

• Study Design & Oversight
• Design, oversee, and interpret preclinical studies (non-GLP and GLP), including pharmacology, biodistribution, and toxicology studies
• Select, negotiate, and manage CROs and external partners
• Write, review, and edit preclinical study reports and nonclinical sections of regulatory submissions
• Ensure data, methods, studies, and reports meet FDA, EMA, and ICH guidelines
• Strategic Leadership
• Define and implement the nonclinical development strategy for RNA editing programs from candidate selection through IND submission
• Identify key risks, mitigation strategies, and timelines for nonclinical workstreams
• Maintain up-to-date knowledge of regulatory guidance and emerging science in RNA editing, gene therapy, and AAV biology
• Collaboration & Communication
• Partner with discovery scientists to inform candidate selection strategy
• Work with manufacturing and analytical teams to ensure efficient hand-offs and successful integration of data across functions
• Communicate findings and recommendations clearly to project teams, leadership, and external stakeholders

Qualifications:

• PhD in Pharmacology, Toxicology, Biology, or related discipline
• At least 5 years in a biotech/pharma environment
• Experience in drug development for ocular and CNS indications
• Demonstrated track record of designing, monitoring, and interpreting preclinical safety & efficacy studies for IND submissions
• Strong understanding of FDA and ICH guidance on gene therapy
• Proven success in managing CROs and vendors for GLP/non-GLP studies
• Experience integrating nonclinical data into regulatory submissions
• Ability to synthesize complex data sets and communicate effectively across functions
• Ability to travel up to 25% of the time

Preference will be given to those who display:

• High motivation, with a strong work ethic and dedication to generating impact
• Attention to detail, with the ability to extract deep insights from data
• Ability to go from ideation to data in an independent fashion
• Long-term personal vision with defined career goals
• Team-oriented thinking
• Demonstrated excellence in small team environments, including a “no task is too small” attitude

If you have a passion for advancing gene editing technologies and desire to be part of a pioneering biotech company, we encourage you to apply and join our ambitious team.

Please apply directly through LinkedIn.

Amber Bio is an equal-opportunity employer and encourages applications from candidates of diverse backgrounds. We value diversity and are committed to creating an inclusive and supportive work environment for all employees.