Information Technology For Development Jobs in Stanford, CA

684 positions found — Page 13

Strategic Account Director, Electronics
Salary not disclosed
Sunnyvale, CA 1 week ago

Pacific International has been exclusively retained by a global leader in the development and production of consumer electronic components, enabling their customers to innovate and expand capabilities.


As they have sustained themselves as a global market leader, they are looking for an Account Director to further expand their reach in the consumer electronics industry. This is a highly visible position with the opportunity to build and deploy strategies for a global organization.


Key Responsibilities

  • Lead customer strategy, serving as the primary point of contact and building strong cross‑functional relationships while overseeing commercial and technical initiatives.
  • Identify new technology opportunities, expand engagement across business units, and pursue growth with additional OEMs by aligning solutions to customer roadmaps.
  • Coordinate with global engineering, operations, and program teams to drive successful development from concept through mass production.
  • Lead pricing negotiations, contract and agreement reviews, and annual planning to drive revenue growth while ensuring profitability and long‑term alignment.
  • Monitor market trends, emerging technologies, and competitive activity to guide strategy.
  • Maintain accurate forecasting, pipeline visibility, and account documentation using CRM and internal tools.


Ideal Candidate Profile

  • Bachelor’s degree in engineering, Business, or a related field
  • 7-10+ years of sales experience in the consumer electronics or electronic component industry.
  • Direct experience managing relationships with consumer electronic OEMs is required.
  • Experience managing global customers,
  • Proven ability to manage multi-stakeholder accounts within the consumer electronics industry.


About Pacific International Executive Search:

Pacific International, a globally recognized retained executive search firm, is dedicated to empowering Fortune 500, FTSE 100, and high-growth enterprises in building exceptional C-suite, senior-level, and strategic leadership teams while championing diversity and inclusion. Our adaptability, agility, and forward-thinking ethos distinguish us in the ever-evolving business landscape.

Since 1997, we have been dedicated to building lasting client partnerships based on trust and reliability, and a proven track record of successful C-suite and mid- to senior-level leadership project delivery across many key industries globally.


Diversity Statement:

At Pacific International, diversity, equity, and inclusion are at the core of who we are and what we do. Our commitment to these values is unwavering and we proudly champion diversity on behalf of our clients in every Executive Search mandate we undertake. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. In pursuit of these objectives, we actively encourage applications from individuals of all backgrounds and identities.

Not Specified
Head of Operations and Manufacturing
Salary not disclosed
Sunnyvale, CA 5 days ago

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
Not Specified
Senior Manufacturing Process Engineer
Salary not disclosed
Sunnyvale, CA 5 days ago

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
Not Specified
System Integration Test Lead
Salary not disclosed
Cupertino, CA 4 days ago

System Integration Test Lead


Summary:


We are seeking a Technical Program Manager (TPM) with system-level experience to tackle new challenges and leverage your expertise in this dynamic role. This company offers a fast-faced, innovate culture with abundant information, requiring you to quickly process and develop clear plans to resolve issue efficiently.

Be part of a leading consumer technology company and make a significant impact by leading programs and driving manufacturing test readiness!


Responsibilities :

  • Oversee the preparation and execution of test readiness activities, including managing the transition from Surface-Mount Technology (SMT) to final assembly across all phases of product New Product Introduction (NPI) development.
  • Plan, execute, and complete dry runs to ensure manufacturing test readiness for NPI builds, identifying potential issues before full production.
  • Quickly identify, troubleshoot, and resolve any test-related issues that arise during the build process, ensuring minimal disruption and maintaining timelines
  • Create and implement strategic plans for addressing problems, ensuring timely and effective solutions.
  • Work closely with engineering, manufacturing, and other cross-functional teams to ensure seamless communication and alignment on project goals and deliverables
  • Regularly track and report on the status of test progress, readiness, and outcomes, ensuring transparency and accountability throughout the project lifecycle
  • Continuously refine and improve test processes and methodologies to enhance quality, efficiency, and product maturity, ensuring compliance with industry standards and best practices
  • Ensure product test quality standard and manufacturing criteria are met


Requirements

  • Proven experience in program management or test readiness at the system level, with a strong background in hardware and software integration
  • Understanding of HW/SW architecture and interoperability of a complex systems
  • Strong analytical and problem-solving skills, with the ability to thrive in a fast-paced environment
  • Excellent communication and organizational skills, with the ability to articulate complex issues clearly
  • Knowledge and experience in New Product Introduction (NPI) for consumer products, enabling efficient issue resolution and build execution
  • Experience in consumer product manufacturing tests and hardware/software integration is a plus
  • Engineering degree in ME, CE, EE or Physical Sciences prefer


Location: Cupertino, CA (Hybrid, Tuesdays - Thursdays Onsite)

Duration: 12-36+ Months

Pate Rate Range: $70/hr - $80/hr (DOE)

Not Specified
Program Manager High-volume Manufacturing (HVM) in Electronics 
Salary not disclosed
Cupertino, CA 4 days ago

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Program Manager High-volume Manufacturing (HVM) in Electronics


Job Description:

Job Title: Program Manager High-volume Manufacturing (HVM) in Electronics

Job Type: Fulltime

Job Location: Cupertino, CA

Work Schedule: Onsite

Salary: 150k to 160k, Based on experience


The Project Manager will manage the relationship with Contract Manufacturers and oversee projects from customer commitment to implementation.


Responsibilities:

  • Manage projects from customer commitment to implementation, ensuring on-time, on-budget delivery.
  • Define project scope, timelines, and resource needs, and develop project specifications.
  • Provide regular status updates to senior management and team members.
  • Maintain project tracking documentation and support the development of BOMs for new items.
  • Coordinate with R&D, Operations, and Engineering teams to manage product formulas, production capability, and testing.
  • Manage change part communications and coordinate trial schedules with Quality and Production teams.


Qualifications:

  • 5-10 +years of project management experience.
  • Strong communication, problem-solving, and organizational skills.
  • Ability to work effectively in cross-functional teams and manage multiple projects simultaneously.
  • Worked with Technology CMs like – Foxconn, Pegatron, Wistron, Compal, Quanta, Tata, Inventa, Flextronics or Flex, Jabil, Luxshare, BYD Electronics
  • Worked with large global companies and drove the relationship with the CM. Large global companies include – Apple, Microsoft, Sony, Dell, HP, Meta, ASUS, Acer, Cisco, Huawei etc…
  • Must be able to work under pressure
  • Must be able to travel to China
  • Able to speak Mandarin a big plus


About Maxonic:

Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.


Interested in Applying?

Please apply with your most current resume. Feel free to contact Jhankar Chanda ( /(4 for more details.

Not Specified
Lead PMIC Design Engineer (RTL)
🏢 SBT
Salary not disclosed
Sunnyvale, CA 2 days ago

SBT is the exclusive retained recruiting firm for this position.


Company Overview

This confidential startup is a well-funded early-stage semiconductor company focused on advancing AI-driven design to address emerging challenges in the artificial intelligence ecosystem. The company is developing innovative technologies that leverage automation and machine learning to accelerate the design and development of complex analog semiconductor solutions. By applying AI to traditionally manual and time-intensive design processes, the organization aims to unlock faster innovation cycles and enable the next generation of AI hardware infrastructure.


Job Role

  • Design and implement digital control logic for power management ICs
  • Work closely with analog engineering teams to ensure effective integration between digital control blocks and analog power circuitry
  • Develop high-quality, power-efficient RTL using Verilog or SystemVerilog to support key features
  • Contribute to product readiness for manufacturing by supporting design-for-test methodologies
  • Create and execute comprehensive verification strategies, including mixed-signal simulations and behavioral modeling


Qualifications

  • BS or MS degree in Electrical Engineering, Computer Engineering, or a related field.
  • 10+ years of experience in digital IC design, including significant experience developing solutions for mixed-signal or power management semiconductor products.
  • Strong proficiency in RTL development using Verilog or SystemVerilog for synthesizable digital design.
  • Hands-on experience designing digital control logic for power conversion systems, including control loops used in power management or DC-DC converter applications.
Not Specified
Manager Client Programs and Events
Salary not disclosed
Palo Alto, CA 2 days ago

Manager, Client Programs & Events

Hybrid | Palo Alto, CA

The Opportunity

A leading global law firm is seeking a Manager, Client Programs & Events to join its Business Development and Marketing team in Palo Alto (hybrid).

This role supports client engagement initiatives across West Coast offices, with a focus on California-based programs in Palo Alto and Los Angeles.

The Manager will lead the planning and execution of high-impact client programs and events, including CLE seminars, webinars, receptions, dinners, and other business development initiatives that strengthen client relationships. This is a great opportunity for a strategic events professional who thrives in a fast-paced professional services environment, enjoys collaborating with senior stakeholders, and is passionate about creating meaningful client experiences.

Key Responsibilities

  • Plan and execute in-person and virtual client programs, CLEs, and special events.
  • Partner with business development teams, practice groups, and leadership to align events with client development goals.
  • Manage event logistics including venues, vendors, contracts, and onsite execution.
  • Develop event concepts, agendas, and programming to support business development initiatives.
  • Prepare and manage event budgets, tracking costs and ensuring efficiency.
  • Provide guidance to stakeholders and conduct post-event analysis to inform future programs.
  • Track and report event data and KPIs for leadership and practice initiatives.
  • Ensure CLE and educational programs meet accreditation and compliance requirements.
  • Mentor junior team members and foster a collaborative team environment.
  • Monitor industry trends and emerging technologies to maintain innovative programs.

Qualifications

  • Strong experience in event planning and client program management in professional services.
  • Excellent interpersonal, communication, and project management skills.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Strong analytical and problem-solving skills, with discretion handling sensitive matters.
  • Proficiency in Microsoft Office; experience with CRM/database platforms (InterAction a plus).
  • Familiarity with legal industry business development practices is highly valued.
  • Flexibility to travel and adjust work hours as needed.

Education & Experience

  • Bachelor’s degree required
  • Minimum 7+ years of experience in event management, client programs, or business development within law firms with client-focused environments.

If you’re passionate about creating exceptional client experiences and leading high-profile events, we want to hear from you.

Not Specified
3D Manufacturing Engineer
✦ New
Salary not disclosed
Cupertino, CA 1 day ago

Triple Crown is a leading provider of hardware, embedded, software, and mechanical engineering talent. Businesses and technology teams, from Fortune 500 enterprises to emerging startups, rely on our ability to rapidly place the developers, architects, coders, and designers who engineer digital transformation and growth.


Job Type: Contract

Duration: 12+ Months

Location: Onsite in Cupertino, CA

Requirement: 5+ years of experience


We are seeking an experienced Additive Manufacturing Process Engineer specializing in Laser Powder Bed Fusion (LPBF) to drive development, optimization, and scale-up of metal additive manufacturing processes. This role focuses on translating product and design requirements into robust, high-quality, and production-ready manufacturing solutions.


Minimum Qualifications

  • BS in Mechanical Engineering, Materials Science, Manufacturing Engineering, or related field
  • 5+ years of hands-on experience with metal LPBF processes
  • Strong understanding of LPBF process fundamentals: laser-material interaction, melt pool dynamics, defect formation
  • Experience with LPBF parameter development and process optimization
  • Proficiency in statistical methods and DOE for process development
  • Track record of taking AM processes from development to production


Skills:


  • Manufacturing
  • Metal Additive Manufacturing
  • AM Processes
  • NetFabb
  • 3D Printing
  • Material Characterization


Benefits:


  • Paid weekly!
  • Health, Dental and Vision Insurance
  • 401k
Not Specified
Cable Manufacturing Process Engineer
✦ New
🏢 Maxonic Inc.
Salary not disclosed
Sunnyvale, CA 1 day ago

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Component Engineer 4.


Job Description:

Job Title: Component Engineer 4

Job Type: Contract

Job Location: Sunnyvale, CA

Work Schedule: On-site

Pay Rate: $94 Based on experience.


DESCRIPTION:


Primary Function of the Position:

  • Responsible for ensuring suppliers meet ISI requirements for quality, service, delivery, and cost. Drive suppliers to continuously improve business and manufacturing processes specifically related to wire harness and cable assembly.
  • Evaluate and select suppliers within copper cables/harness industry. Guide Engineering in choosing suppliers for new products and providing DFM input to new designs. Supports both NPI and on-going production, monitors and works with suppliers to improve supplier performance. Executes detailed projects with suppliers to implement changes and improvements affecting quality, cost, capacity, risk, and sub-supplier management.

Essential Job Duties:

  • Work with NPD to procure custom cables ensuring DFM to achieve quality and cost targets
  • Support NPD with proto builds and track material readiness at Supplier Drive supplier root cause analysis for cable harness failures
  • Mitigate risks and ensure supply continuity by evaluating capacity, lead times and quality issues
  • Develop and maintain harness standards, specifications, and design guidelines.
  • Work with Strategic Sourcing to evaluate new suppliers and new supplier manufacturing sites
  • Complete project/ part qualification deliverables including Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability AnalysisWork with suppliers to execute cost reductions, capacity improvements, and risk mitigation.
  • Select the right process and supplier for the part, considering long-term fit and total cost of ownership.
  • Manage supplier changes including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations.
  • Drive changes to ISI requirements as necessary by initiating and managing changes to specifications and drawings through the engineering change order process.
  • Own and drive to closure supplier variances from symptom through root cause analysis to corrective action, including careful CAPA documentation.
  • Effectively prioritize and advance multiple concurrent projects and tasks Clearly communicate project status to key stakeholders Build, own, and relentlessly pursue a vision for developing suppliers.
  • Understand proper level of documentation detail for tracking of actions and justification of decisions.
  • Generate key metrics for the team and suppliers and continually drive for timely achievement of those metrics.
  • Drive suppliers to continually improve their business and manufacturing process performance to meet requirements for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation. Lead these efforts without managerial guidance at several suppliers simultaneously.
  • Implement corrective and preventive actions for supplier process by driving supplier’s investigations and root cause analysis.
  • Provide effective and timely supply base information and recommendation to management by creating and delivering data-driven supply base information to any level of management at ISI with little or no guidance.
  • Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation.
  • Work with suppliers and ISI engineering for the new product introduction to: Create product supplier landscapes to determine launch readiness and report to management.
  • Develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability.
  • DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production.
  • Influence and guide Engineering in choosing suppliers by determining selection criteria for preferred suppliers and leading the team effort to evaluate preferred suppliers.
  • Review, analyze and close customer complaints, manufacturing variance requests, and first article inspections by judging risk analyses and justifications.


Required Skills and Experience

  • Minimum 7 years related experience with an BS Engineering degree or 5 years’ experience with MS in Engineering.
  • Excellent written and verbal communication skills including presentations to executive level management.
  • Excellent Interpersonal skills and team building skills.
  • A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers.
  • Excellent Project Management skills.
  • Excellent analytical and problem-solving skills along with good judgment.
  • Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities.
  • Demonstrable knowledge of a wide range of manufacturing processes including understanding of key input variables for quality, cost, and capacity (Specialization can be in cable assembly, wire cutting, termination, crimping, Soldering, overmold)

Working Conditions

  • Ability to travel to suppliers on an as-needed basis – domestic and international.

Preferred Skills and Experience

  • 4-7 years of engineering experience in cable assembly, wire harness production, or electromechanical manufacturing.
  • The ideal Candidate possesses broad and deep hands-on cable assembly experience along with wire cutting, stripping, crimping, soldering,


About Maxonic:

Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.


Interested in Applying?

Please apply with your most current resume. Feel free to contact Manish Rajput ( /(4 for more details.

Not Specified
Senior Andrologist
Salary not disclosed
Sunnyvale, CA 2 days ago

Senior Andrologist (California CLS Required) – Fertility Clinic


Job Summary

The Senior Andrologist is responsible for performing and overseeing advanced andrology and reproductive laboratory procedures within a fertility clinic setting. This role supports male fertility evaluation, endocrine testing, and assisted reproductive technologies (ART) by performing semen analyses, sperm preparation, and hormone testing while ensuring compliance with California laboratory regulations.

The Senior Andrologist also supervises andrology laboratory operations, maintains quality control standards, and collaborates closely with reproductive endocrinologists, embryologists, and clinical staff to support patient care.


Key Responsibilities


Andrology Laboratory Testing

  • Perform diagnostic semen analysis according to WHO guidelines and laboratory protocols.
  • Conduct advanced sperm function testing including:
  • Morphology assessment
  • Motility and vitality analysis
  • Sperm concentration and total motile count
  • DNA fragmentation testing when applicable
  • Prepare sperm samples for assisted reproductive technologies (ART) including:
  • Intrauterine Insemination (IUI)
  • In Vitro Fertilization (IVF)
  • Intracytoplasmic Sperm Injection (ICSI)
  • Process surgical sperm retrieval samples including TESA, PESA, and micro-TESE.


Endocrinology & Hormone Testing

  • Perform and oversee reproductive endocrinology testing related to fertility diagnostics.
  • Operate immunoassay analyzers including Roche Cobas e411 for hormone testing (e.g., FSH, LH, Estradiol, Progesterone, AMH, Testosterone, hCG, Prolactin).
  • Perform linearity verification and calibration verification (CALVER) as required by laboratory validation protocols.
  • Conduct and document CAP Proficiency Testing (PT) in compliance with CLIA and CDPH regulations.
  • Troubleshoot analyzer performance issues and perform corrective actions as needed.
  • Perform routine and scheduled instrument maintenance, calibration checks, and functional verification of the analyzer.
  • Monitor assay performance and maintain quality documentation for regulatory inspections.


Sperm Banking & Cryopreservation

  • Perform sperm cryopreservation and thawing procedures for fertility preservation and donor banking.
  • Maintain specimen tracking and chain-of-custody documentation.
  • Ensure compliance with CAP, CLIA, FDA tissue regulations, and California Department of Public Health (CDPH) requirements.


Laboratory Operations & Quality Management

  • Maintain compliance with California Clinical Laboratory licensing regulations.
  • Implement and maintain laboratory quality assurance and quality control programs.
  • Perform method validation, verification, and instrument performance checks.
  • Assist with preparation for CAP, CLIA, and CDPH laboratory inspections.
  • Maintain laboratory documentation, standard operating procedures (SOPs), and regulatory records.


Leadership & Training

  • Supervise and train andrology and laboratory technologists.
  • Ensure staff competency and continuing education compliance.
  • Assist in development and updates of laboratory SOPs.
  • Participate in laboratory audits and regulatory readiness activities.


Clinical Collaboration

  • Work closely with reproductive endocrinologists, urologists, embryologists, and nursing staff.
  • Provide consultation regarding male fertility testing, sperm preparation methods, and endocrine laboratory results.
  • Participate in multidisciplinary patient case discussions and treatment planning.


Required Qualifications


Education

  • Bachelor’s degree or higher in Clinical Laboratory Science, Biology, Biochemistry, or related field.


Licensure

  • Active California Clinical Laboratory Scientist (CLS) License issued by the California Department of Public Health (CDPH).


Experience

  • 5+ years of laboratory experience, preferably in fertility, andrology, or reproductive medicine laboratories.
  • Experience performing semen analysis, sperm preparation for ART, and hormone immunoassay testing.
  • Experience operating and troubleshooting Roche Cobas e411 or similar immunoassay analyzers.


Preferred Qualifications

  • Experience working in IVF or assisted reproductive technology laboratories.
  • Familiarity with CAP accreditation standards, CLIA requirements, and CDPH regulations.
  • Experience with instrument validation, proficiency testing programs, and regulatory inspections.


Key Skills

  • Advanced knowledge of male fertility diagnostics and semen analysis techniques
  • Expertise in ART sperm preparation methods
  • Strong knowledge of endocrinology testing and immunoassay instrumentation
  • Ability to troubleshoot laboratory instruments and perform technical maintenance
  • Thorough understanding of CAP, CLIA, and CDPH regulatory compliance
  • Strong attention to detail and laboratory documentation practices
  • Effective leadership and communication skills


Work Environment

  • Fertility clinic laboratory setting
  • Handling of human reproductive specimens and biological materials
  • May require early morning, weekend, or on-call work depending on clinical schedules
Not Specified
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