Principal engineer jobs in California

My client is an innovative medical technology company with a non-invasive product for chronic disease, including neurological disorders. Due to recent growth, they are seeking a Principal Firmware Engineer to drive improvements on new projects as well as sustaining technology. This role offers the chance to join a rapidly growing, innovative team and to be part of an industry-changing solution. The Principal Firmware Engineer will join the existing product development team, and will act primarily as an individual contributor, while also exercising a leadership role to provide support, mentorship and technical leadership to more junior engineering team members. To be the Principal Firmware Engineer, you will need: A BS or MS in computer science, Computer Engineering or Electrical Engineering 10+ years of firmware engineering experience, specifically within low-power/small footprint design Technical experience including microcontrollers ARM Cortex (M0, M3, M4) ISO13485 C/Linux/Zephyr/free RTOS programming skills Expertise with radio/RF technology, including WiFi, NFC, BTLE, LTE/5G and cellular modem Cross-collaboration ability, and strong communication skills This role offers a competitive salary, comprehensive health benefits and 401k. It based in the San Francisco Bay Area. If the Principal Firmware Engineer role sounds like you, please click apply now or drop me a message. Share with your network too, if this is not quite right for you but could be perfect for someone you know!

Meacor Inc. - Irvine, CA (Onsite) Meacor is pioneering the future of valvular repair with a truly novel transcatheter device that leverages groundbreaking on-demand cryoadhesion technology. We're not just improving existing solutions; we're building something fundamentally new to address critical patient needs. Fresh off a successful Series A funding round, we have the momentum and resources to accelerate development and bring this innovative platform to the clinical field. Located in the vibrant medical device hub of Irvine, California, our team thrives in a dynamic environment supported by robust in-house prototyping capabilities. The Opportunity Meacor is seeking a Senior R&D Engineer to develop and validate the next-generation mitral and tricuspid valve repair devices. You will be a core part of our team, focused on the development of the implant and its integration with the delivery system. In this hands-on position you will: · Define and execute design verification strategies and develop test procedures to ensure product requirements are met. · Drive the design and development of critical implant sub-components, including anchors, sutures, and cinching mechanisms. · Translate physician and clinical feedback into actionable engineering requirements. · Collaborate closely with R&D, clinical, and manufacturing teams, supporting product transfer into a cleanroom manufacturing environment. This role requires a balance of technical design expertise, clinical insight, and practical problem solving, along with the ability to foster strong relationships across teams and with physicians. Key Responsibilities This role is a senior individual contributor position with opportunities to lead project-level initiatives. · This role is a senior individual contributor position with opportunities to lead project-level initiatives. · Define and execute design verification strategies, including test methods, custom fixtures, and equipment. · Develop and maintain product specifications to ensure compliance with engineering requirements and clinical use cases. · Interpret medical imaging and collaborate with physicians to translate clinical insights into actionable engineering solutions. · Partner with manufacturing to establish scalable, reproducible processes and support transfer into a cleanroom environment. · Contribute to preclinical, regulatory, and clinical trial activities by supporting testing, documentation, and submissions in accordance with ISO 5840, ISO 5910, FDA, and EU MDR requirements. · Prepare high-quality technical documentation and communicate results to internal teams and external stakeholders. · Establish internal standards and inspection methods for components and final devices to ensure consistent quality. Required Skills & Qualifications · Bachelor of Science in Engineering required; advanced degree preferred. · 7+ years of engineering experience, including direct work with structural heart implants; annuloplasty experience strongly preferred. · Proficiency in CAD software (SolidWorks preferred) for 3D design and technical drawings. · Deep understanding of cardiac anatomy, clinical workflows, and imaging modalities (echocardiography, fluoroscopy); prior cath lab or physician interface experience desirable. · Hands-on experience with design, prototyping, and collaboration on manufacturing methods (3D printing, machining/lathe, laser welding) within a QMS. · Experience supporting regulatory submissions (FDA IDE/PMA, EU MDR) and contributing to pre-clinical or early clinical trial activities is highly desirable. · Familiarity with testing standards such as ISO 5840 and ISO 5910. · Working knowledge of statistical techniques such as design of experiments (DOE), tolerance analysis, and verification testing. · Strong documentation, communication, and interpersonal skills, with the ability to collaborate effectively across technical teams and with clinicians. Why Join Meacor? · At Meacor, you will be part of a team at the forefront of medical innovation, where your work has a direct impact on patients' lives. We foster a culture of creativity, collaboration, and technical excellence, giving you the resources and support to drive meaningful innovation. Our leadership team brings decades of collective experience in structural heart innovation, with a track record of successful startups, clinical trials, and product launches. · Contribute to the development of a first-in-class transcatheter device utilizing novel on-demand adhesion technology. · Reporting to a C-level executive, this is a hands-on senior individual contributor position with significant technical leadership. The role includes ownership of critical implant subsystems and the opportunity to mentor junior team members, driving projects from concept through verification and validation. · Work in a highly collaborative environment with state-of-the-art in-house prototyping and manufacturing capabilities for rapid iteration. · Engage directly with world-class clinicians to ensure our solutions address critical real-world patient needs. · Receive a competitive compensation package commensurate with experience, including a market-based salary ($130k-170k), equity participation, and comprehensive benefits (health, dental, vision, 401(k), and paid time off)

About CoFlo CoFlo Medical's core annular flow devices reduce drug delivery injection forces by >200x, unlocking high-concentration, high-viscosity delivery beyond 1,000cP. CoFlo is collaborating with biopharmas to develop high-dose combination products that enable low-cost, less-frequent, and at-home treatment. Founded out of MIT and venture-backed, our team is reimaging healthcare with the mission of increasing patient access to life-saving therapies. What You'll Do You'll join our team as a Senior or Principal Device Engineer on the journey from early stage to FDA-ready device. You will lead and execute a wide range of device engineering responsibilities to enable CoFlo's progression through proof of concept, manufacturing scaleup, first-in-human, submission, and marketing. You will contribute to delivery devices across modalities, from large- and small-volume subcutaneous delivery to intravitreal injections and more. Your responsibilities will include: Drive device design from user needs through design freeze Organize and execute verification testing, human factors, and risk mitigation Manage vendor selection, tooling, sterilization, and packaging development Author data packages and documentation for regulatory submissions Requirements BS or higher in related field >5 years of experience in medical devices Desire to work in a fast-paced, high-agency environment Proven track record in most or all of the following: Design Controls and Risk Management, Design Transfer, Vendor Management (CRO, CMO, testing, etc.), User Needs and Human Factors Engineering, Verification and Validation Experience with needle-based injection device systems (Bonus) Literacy in specific needle-based injection system standards (ISO 11608, 11040, 10993, 11135) (Bonus) Startup or small-team experience What We Offer An opportunity to make a visible impact on a meaningful medical device and to grow with a fast-paced company. We also offer competitive salaries, early-employee equity, 401(k), health, dental, and vision insurance. Title will be commensurate with experience.

The Sr. Fiber Optic R&D Engineer will have experience in optical fiber technologies for medical device applications. Ideal candidate will possess knowledge of fiber processing techniques and the ability to develop and optimize manufacturing processes to enhance product performance, reliability, and manufacturability. Additionally, the Sr. Fiber Optic R&D Engineer will be a key contributor to the design and development of a therapeutic medical device, from concept to early human use to pivotal trial readiness. Contribute as part of a cross‐functional team in product design and development, process development and optimization, and verification & validation testing to support product transfer to manufacturing. Position Overview: Process Development: Through hands-on technical execution, lead the development, optimization, and validation of optical fiber manufacturing processes, including polishing, cleaving, splicing, ferrule inspection, coupler / combiner / splitter assembly, glass processing, and sensor fabrication. Leads scaling up processes from development to full scale manufacturing. Manages processes and ensures that activity goals are achieved. Development Team: Represent Process Engineering in assigned R&D and Project Team meetings for technology transfers and provide technical expertise and support in analytical method development, validation and process scale, and current production capabilities in manufacturing. Successful completion of engineering work in product design and development, test methods, research investigation (animal and clinical studies), and report preparation. Equipment Utilization: Operate and maintain state-of-the-art fiber processing equipment, including Fujikura cleavers and splicers, Domaille polishers, glass processors, fiber inspection scopes, and Keyence microscopes. Technical Expertise: Provide in-depth knowledge of various fiber types (single-mode and multimode), fiber coatings, clad thicknesses, and materials. Ensure compliance with industry standards and best practices. End Face Processing: Design, optimize, and implement end face fiber processing techniques. Fiber Optic Sensors: Demonstrate expertise in fiber optic sensor technologies, applications, and fabrications including sensors for imaging, pressure, temperature, and acoustic / vibrations.Ability to fabricate / process ball lenses and polish fibers / lenses. Connector Knowledge: Demonstrate expertise in common fiber connectors, including single fiber ceramic ferrules, multi fiber ferrules (MT), and linear ferrule arrays, to enhance assembly and reliability. Demonstrate competence in ferrule polishing and polishing recipe development. Testing and Validation: Set up optical test configurations for launching light into fibers, measuring light transmission, and conducting performance evaluations. Analyze data to drive continuous improvement initiatives. Performs or manages process validations (IQ/OQ, OQ, PQ). Perform Verification and Validation (V&V) and may draft protocols/reports for approval. Conducts testing to verify that the design meets the engineering specifications. Collaboration: Work closely with cross-functional teams, including R&D, quality assurance, and production, to ensure alignment on process development goals and product specifications. Creates and manages a schedule of technical deliverables in coordination with a project manager. Provides training and guidance to technicians and less experienced engineers. Documentation and Reporting: Prepare and maintain detailed documentation of processes, test results, and validation protocols. Present findings to stakeholders and contribute to technical reports. Draft design transfer documentation. Prepare documentation to support quality system for design functions (project plans, concept document, FMEA, design input, test results, drawings, etc.). Prepare technical documentation, including manufacturing instructions, test methods, drawings, BOMs, protocols, and reports to support design control activities. Document engineering work in compliance with the company's quality system. Continuous Improvement: Evaluate current catheter manufacturing practices and identify those needing improvement. Use lean manufacturing techniques to maximize manufacturability. Statistical Analysis: Use Six Sigma Methodology (DMAIC or DMADV) and tools including Minitab, FMEA, Fishbone, Process Mapping, etc. Compiles and analyzes data to identify root causes, draw conclusions, generate solutions, and generate reports. Translates highly technical results into easily understandable recommendations that will influence cross-functional and senior stakeholders. Risk Mitigation: Identifies hazards and mitigates risk associated with identified hazards in Design and Process FMEA. Assess failure modes and conduct technical risk analysis. Design: Able to design process fixtures and tools. Support the development of specifications for tooling and fixturing according to company quality standards. Work with engineers and QA to create designs for new products, product revisions, components, assemblies, or tools. Qualifications: Education: Engineering degree desired or equivalent experience in related job field Required Experience: 3+ (Sr.) or 5+ (Staff) years of relevant experience in optical fiber process development preferably in medical device industry or biomedical product / medical device development. Experience with fiber optic processing including cleaving, tapering, fusion splicing, and terminating / polishing ferrules. Working knowledge of mechanical design principles and FDA regulated medical device design controls. Proficient in CAD software, preferably SolidWorks. Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred. Understanding of IEC60601 requirements/constraints for mechanical system design is preferred. Hands-on experience managing suppliers and/or contract manufacturers. Track record of strong cross-functional collaboration, influence without authority, and project management enabling highly effective project team. Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results. Excellent hands-on mechanical prototyping, verification, and failure analysis skills. Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA). Knowledge, Skills, and Abilities: Proficient in Risk Management according to ISO 14971. Knowledge of ASME Y14.5 GD&T. Excellent interpersonal, communication, and documentation skills are required. Takes initiative and acts quickly to drive solutions. Strong interpersonal, organizational and communication skills. A flexible team player, focusing on shared goals with a positive results‐oriented attitude. Skilled problem solver, proficient in problem solving methodologies

Honey Health is the all-in-one AI back office for primary and specialty care. Our AI agents autonomously handle core back-office jobs, such as aggregating patients data, processing orders and prescriptions, automating prior authorizations, triaging faxes and referrals, and managing RCM(revenue cycle management). Organizations using Honey frequently cut administrative costs in half while improving staff/patient satisfaction and increasing revenue. Built with enterprise-grade security and privacy, our platform delivers real operational transformation. About the Role Honey Health is seeking a Senior/Staff Software Engineer to build leading AI Agent systems that transform healthcare operations. In this role, you will design and implement the infrastructure for training and deploying highly useful AI Agents in healthcare. Our team's mission is to create seamless, robust platforms for AI Agents - enabling them to operate at scale and perform complex tasks safely and autonomously. You'll work closely with AI researchers, product teams and operation teams to translate cutting-edge technical research into impactful healthcare applications, automating back-office works and improving patient care. The ideal candidate is passionate about being the builder of AI Agents (especially in healthcare) and relentless in pursuing high-quality, safe, and beneficial AI systems. This is a full-time role based in the U.S., offering the opportunity to lead innovation at the intersection of AI and healthcare. Is This You? You're fired up about Agentic AI and ready to help shape the future of healthcare. You're joining at the perfect moment to build transformative AI agents, and you're here to learn fast, contribute boldly, and grow into a leader in this space. You're deeply driven to make a meaningful impact - shaping team culture at Honey, redefining value for healthcare providers and patients, and pushing the boundaries of innovation in one of the most impactful industries. You don't just solve problems - you tackle the hardest ones with ambition and drive. You bring relentless energy, even in the face of complexity, always aiming for excellence when it matters most. You bring infectious energy and initiative - sparking bold ideas, asking the right questions, and inspiring the team to explore ambitious paths in a fast-moving, open and exploratory environment. If these describe you, we should definitely talk. In this role, you will: Architect and invent next-generation AI agent infrastructure to train and deploy healthcare AI agents, ensuring the platform is efficient, reliable, and scalable for large-scale workloads and healthcare production environments. Integrate the latest LLM advancements and in-house research into the agent platform, leveraging generative AI and reinforcement learning to continuously enhance agent capabilities. Prototype and integrate AI agents with real healthcare data and services to enable reliable, safe automation in complex workflows (e.g. automating administrative tasks), and design secure sandboxed execution environments to ensure robust operations. Collaborate with healthcare experts to turn novel AI research into practical features, and with pilot customers and clinicians to validate and refine the value in healthcare. Uphold high standards in code quality, testing, and reliability, continuously improve processes & monitoring to deliver an excellent experience for healthcare users. You might thrive in this role if you: 8+ years of industry-related experience. Fueled by a vision to use AI as a force for innovation, care improvement, and system-wide change in healthcare. You've built cutting-edge AI and Agentic systems, ranging from tool-calling stacks to MCP-style frameworks, and bring hands-on experience with LangChain, context engineering, and RL-enhanced agents. Know how to build new things from 0-1 quickly, and then scale them 1,000,000x. Have a strong product mindset with a focus on quality and user impact, care about solutions being technically sound and improving end-user workflows, and have a knack for iterative improvement, testing, and delivering high-impact features. Committed to never settling - pushing limits through continuous improvement, precision, and a mindset to lead. Join us at Honey Health and apply your expertise and talent in AI agents to solve real-world healthcare challenges. You will be at the forefront of a new era where Agentic AI systems meaningfully improve healthcare - from reducing administrative burden to enabling better patient care - all while working with a team that values innovation, safety, and impact. We look forward to your curiosity, ownership, and drive in pushing the boundaries of what AI agents can do in healthcare. Apply now to shape the future of health with us.

: AtaCor Medical is committed to advancing the standard of care in cardiac rhythm management. This mission drives our innovative approach and guides our work to help physicians restore rhythm and preserve life. Position Summary: This position supports the design and development of new products and product improvements in the extravascular cardiac rhythm management space. Responsibilities will include creation and evaluation of design requirements, development and execution of design verification test methods/protocols/reports, supplier interface and multi-disciplinary project team participation. This position is a full-time, on-site role located at our San Clemente, CA office. Essential Functions: Provides engineering support for design and development of new products and product changes Use computer-assisted design software (i.e., SolidWorks) to perform engineering and design tasks Develops and tests prototypes based on design specifications, defines processes to properly manufacture and assemble the product, and optimizes the manufacturing process Analyzes test data to determine if designs meet functional and performance requirements and document findings in test reports Conduct engineering inspections of returned product from clinical studies to support complaint and CAPA investigations Support updates and improvements to QMS procedures Evaluate the impact of external standard changes on products and their Design History Files (DHFs) Leverage knowledge of Risk Management, Regulations, and Procedures to ensure continued product compliance Provides design verification test reports, drawings, and other requirements to Regulatory Affairs necessary for preparing regulatory notifications and submissions such as 510(k)s and PMAs for domestic and international approvals as required Determines realistic start and finish dates for action items imperative to project completion on the project schedule and submits to the project team leader. Provides updates to project schedule as required Identify areas for improvement in lab tooling and technical processes across all project phases and recommend changes to the appropriate management. Supports management of Engineering Lab and provides technical training for appropriate Lab personnel Reviews appropriate technical literature for the necessary background on specific assignments All activities must be performed in compliance with the Quality System Performs duties in compliance with environmental, health, and safety-related site rules, policies, or government regulations Essential Qualifications: Education: BS in Biomedical Engineering, Mechanical Engineering, or equivalent combination of education and experience. Experience: 0-3 years industry experience, preferably in medical device design environment. Working knowledge of light machine shop practice and operation; ability to use shop tools such as drill press, drills, heat sealer, and pull test equipment. Working knowledge of current CAD tools Experience in the use of analytical tools and methods including statistics, DOE, and computer analysis packages. Excellent teamwork and interpersonal skills. Travel: Up to 15-25% Desirable Skills: Experience with SolidWorks Experience working within an ISO or FDA type design control environment. Experience working with a contract engineering or manufacturing firm. Cardiac pacing/defibrillation, implantable, or surgical medical device experience

The Sr. Product Development Engineer designs and develops Class I & II medical devices for eye surgeries, such as vitrectomy probes. These devices have features down to 2 micrometers that need to be precisely manufactured and assembled. As a team member of the R&D Department, close collaboration with the Manufacturing Engineering, Quality and Production Teams is part of the daily routine. Responsibilities include improvement projects as well as end-to-end product developments from concept to manufacturing. Critical thinking is essential at all stages of the development process. RESPONSIBILITIES: Performs complex mechanical designs, engineering analyses and feasibility studies for new components or products Works out the design requirements and determines optimum design choices, including via trade-off studies of various options. Approaches troubleshooting by methodical, scientific means to identify root cause prior to implementing possible solutions through redesign Thorough documentation of work performed, as required by the regulatory environment per 21 CFR 820. Researches, understands, and presents information relating to Regulatory and Environmental Standard compliance requirements as it relates to product and processes. Collaborate with Manufacturing in supplier selection, manufacturability, and the transition from R&D to manufacturing to ensure smooth and efficient design transfer. Supports evaluation for viable Engineering Changes Research new enabling technologies and manufacturing techniques and determine feasibility. Responsible for project related functions including preparing, managing, and facilitating development of plans, schedules, tasks and resources from conception to volume manufacturing Generate technical drawings of systems, components, and interfaces based on inputs provided by others. Provides sustaining engineering support for existing products. Work in a stage-gate product development process following principles of FDA design controls Engage with cross-functional teams including Quality Assurance to ensure smooth project execution. Generates patentable designs and proprietary manufacturing processes. Competitive market analysis REQUIRED SKILLS AND EXPERIENCE: Proficient in SolidWorks, FEA, GD&T Demonstrated ability to solve problems via scientific methodology and analysis (for example Theory of Knowledge) Medical Device experience, FDA 21 CFR 820 & ISO 13485 Familiar with the manufacturing, assembly and bonding processes of consumable medical devices. Experience with sterilization, biocompatibility requirements Developing IQ/OQ/PQ, process validation documents Risk Management per ISO 14971. Requirements definition and traceability through verification and validation testing Works and communicates effectively with people from all levels of the organization Flexible and willing to perform other tasks as assigned Travel - less than 10%, domestic & international EDUCATION: BS in Mechanical Engineering, Physics, or equivalent, 8+ years of experience Advanced degree desirable ADDITIONAL SKILLS AND EXPERIENCE DESIRED: Methodical root cause analysis (DMAIC), detail-oriented Mechanics of materials Electronics concepts to control valves and pumps for liquid management systems Micro-machining techniques Familiar working with suppliers and vendors Use of standard machine tools to fabricate simple tools and fixtures is a plus Annual Compensation: $150,000 - $180,000 DOE (Depending on Experience) Location: San Leandro, CA (Onsite, Full-time) Company Website: *************** Employment Type: Full-time Medical Instrument Development Laboratories, Inc. (MIDLabs) is an equal opportunity employer. We are committed to fostering an inclusive, diverse, and respectful work environment and do not discriminate based on race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, or any other legally protected characteristic. Applicants from all backgrounds are encouraged to apply.

Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems. The Senior Electrical Engineer will be responsible for troubleshooting system issues for hemodialysis devices. Responsibilities include assessing system complaints, performing root cause analysis, conducting tests and providing resolutions; creating and reviewing documentation and related drawings; designing electrical components, circuits or sub-systems of moderate difficulty; Additionally, the role involves planning and coordinating detailed phases of electrical and systems engineering activities for the assigned project, and participating sub-system integration, verification and troubleshooting. Responsibilities: Lead investigations into complex technical issues or failures related to hardware/software sub-components. Diagnoses and proposes solutions for electrical system issues. Complete knowledge and full understanding of engineering, principles, and practices Devises solutions based on limited information and precedents and adapts existing approaches to resolve issues. Uses evaluation, judgment, and interpretation to select the right course of action. Enhance relationships and networks with senior internal/external partners who are not familiar. Conducts engineering activities of electrical design to ensure product features, performance and quality are met within the cost budget and delivered on time. Identifies and specifies electronic subsystems and boards. Documents and analyze design requirements for implementation. Strategizes and develops verification and validation test plans to ensure product requirement specifications are met. Coordinates testing activities with internal teams and external partners to ensure V&V testing deliverables are met. Designs, models, simulates and tests electronic circuits, subsystems and systems. Create schematic drawings, guides PCB layout, generates BOMs and build packages, and coordinates with contract manufacturer on board fabrication and assembly. Supports system integration and troubleshooting, verification and validation, including safety, EMC and reliability. Applies Apply advanced problem-solving techniques, such as root cause analysis (RCA) and failure mode and effects analysis (FMEA), to identify underlying causes and implement robust corrective actions. Works with production to ensure manufacturability and testability of electrical designs. Administrate electrical lab equipment, tools and materials; support board and cable rework and assembly; ensure the lab activities meet the safety and 5S requirements. Qualifications & Requirements: Bachelor's degree in science or engineering Minimum 5 years of related experience or 3 years and a master's degree Familiar with electronic circuits design, including power, analog and digital components and applications. Familiar with EDA tools to do schematics and layout design. Familiar with lab instruments to do measurement and troubleshooting. Strong problem-solving skills with the ability to conceptualize and develop innovative engineering solutions to complex technical challenges. Good hand-on skills of reworking and cabling. Understanding of design for manufacturability and reliability. Knowledge of FDA QSR, ISO 13485, ISO 60601, ISO 14971, experience with test and troubleshooting of electrical safety and EMC is a plus. Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse teams and stakeholders at all levels of the organization. Proven ability to drive results and meet project timelines and milestones while maintaining high standards of quality and compliance. Physical Demands: Sustained periods of time standing and sitting in a laboratory Sitting at a desk utilizing a computer Some lifting of Working Environment: Typical office areas with offices, cubicles and conference rooms. Typical laboratory and chemical storage areas which may contain hazardous compounds requiring adherence to safe handling practices. Travel: Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.

Company: ELIXIR MD Inc. Industry: Medical Devices (Global Aesthetic & Surgical Markets) About Us ELIXIR MD Inc. is a fast-growing fully integrated medical device innovator, headquartered in Irvine, CA, with a proud Made in the USA ethos. Our manufacturing, supply, sales, and support operations are global, with sales in 22 countries (and growing). Our flagship device is transforming the way plastic surgeons practice worldwide. With rapid adoption, global expansion, and highly specialized logistics for a growing portfolio of devices, we are looking for a full-time Junior Firmware Engineer to help design, control, and optimize the embedded intelligence that powers our next-generation platforms. Position Summary The Junior Firmware Engineer at ELIXIR MD supports the design, development, debugging, and verification of embedded control systems for medical devices. Working closely with the electrical, mechanical, and software teams, this role focuses on real-time firmware for microcontrollers, LED drivers, sensors, and system safety logic within regulated design environments. The engineer will help ensure stable performance, compliance with safety standards, and manufacturability through disciplined firmware design and testing. Key Responsibilities Develop and maintain embedded firmware for device control, sensing, and communication subsystems. Collaborate with hardware engineers to define I/O pin maps, electrical interfaces, and control loops. Write efficient, maintainable code in C/C++ targeting ARM-based and other embedded microcontrollers. Implement communication protocols (UART, I2C, SPI, CAN, Modbus) and support hardware bring-up. Assist in system integration testing (power-up, LED drive control, thermal/fan management, interlocks). Support board-level debugging using oscilloscopes, JTAG/SWD tools, and logic analyzers. Participate in firmware verification and documentation under ISO 13485 and IEC 62304 frameworks. Contribute to firmware release management (Git, version control, release notes). Collaborate cross-functionally with QA, Software, and Product teams to ensure traceability and system compliance. Assist with prototype testing, thermal tuning, and failure analysis during early design phases. Qualifications Proficiency in embedded C/C++ development for microcontrollers (STM32, NXP, Microchip, or similar). Familiarity with real-time operating systems (FreeRTOS, Zephyr, or bare-metal firmware). Understanding of circuit schematics, power management, and digital/analog I/O fundamentals. Experience with debugging tools (JTAG, SWD, logic analyzer, oscilloscope). Knowledge of common communication protocols (UART, SPI, I2C, CAN). Familiarity with firmware validation and documentation in regulated (FDA/ISO) environments preferred. Strong analytical and troubleshooting skills. Highly detail-oriented with disciplined coding and version control habits. Excellent collaboration and cross-functional communication skills. Eager to learn in a fast-paced, hands-on medical technology environment. Displays accountability, precision, and proactive problem-solving. Education & Experience Bachelor's degree in Electrical Engineering, Computer Engineering, or related field. 0-3 years of embedded firmware development experience (internship or project experience acceptable). Experience in medical device, robotics, or industrial control systems preferred. Familiarity with ISO 13485 and IEC 62304 documentation standards is a plus.

Our client is seeking a Senior R&D Project Engineer to oversee projects from concept to post-market surveillance. The role requires deep expertise in developing and launching implantable Class II and III devices, navigating stringent regulatory pathways (FDA 21 CFR 820, ISO 13485, PMA/510(k)). Duties and Responsibilities: Lead the entire product development lifecycle for Class II and III implantable devices. Manage project plans (timelines, budgets, resources) and ensure on-time product launches aligned with strategic goals. Ensure strict adherence to design control and regulatory requirements. Translate user needs into technical specifications in collaboration with clinical, marketing, and regulatory teams. Oversee design, development, and testing of implantable mesh products, including material selection and prototyping. Manage verification/validation and draft reports to support regulatory submissions (PMA and 510(k)). Conduct and document risk management activities (e.g., FMEA). Provide technical guidance and serve as the primary liaison with external vendors. Required Knowledge, Skills, and Abilities: Bachelor's degree in Biomedical, Mechanical, Electrical Engineering, or a related field. 7+ years of product development, program/project management, or engineering experience. Proven experience developing and launching Class II and Class III devices. Direct experience with FDA regulatory processes (PMA and 510(k) submissions) is required. Experience with implantable devices, particularly surgical mesh for pelvic floor disorders, is highly desirable.

We're seeking a Senior Electrical Engineer to join our client's growing Supply Chain Engineering team in the Life Sciences sector. This is an onsite role requiring daily collaboration with cross-functional teams including Manufacturing, Quality, and R&D. The engineer will investigate non-conforming materials and part failures, working with prototype analog/digital circuits, schematic capture, and PCB layout. Responsibilities include defining electrical subsystem requirements and ensuring compliance with evolving global safety and regulatory standards. In this role, the Electrical Engineer will work onsite daily, collaborating cross-functionally with teams such as Manufacturing, Quality, and R&D to investigate non-conforming materials and part failures. They'll engage in hands-on work with prototype analog/digital circuits, schematic capture, and PCB layout, while defining subsystem requirements and ensuring compliance with evolving global safety and regulatory standards. The engineer will drive improvements in PCB yield and scrap reduction, troubleshoot high-failure components with suppliers, and manage component end-of-life replacements, including redesigns for manufacturability. They'll lead and support technical projects using Six Sigma and FPx tools, contribute to supplier capacity planning, and participate in quality investigations and lifecycle design changes. The role also involves budget management, cross-functional coordination across global teams, and maintaining strong relationships with procurement, supplier quality, and operations partners to ensure continuity of supply and technical excellence Required Skills & Experience 5+ years of hands-on electrical engineering experience in a medical device environment, particularly within a production setting Familiarity with regulations including but not limited to ISO 13485, FDA and IPC standards Experience in troubleshooting electronics, component debugging, and printed circuit board assembly (PCBA) Ability to be onsite in Milpitas 5x week Nice to Have Skills & Experience Familiarity with laser optic devices Experience working with international suppliers, ideally within efforts to move circuit boards to global markets Proficiency in Six Sigma, Process Excellence, or LEAN methodologies Compensation: $70/hr to $80/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

HCLTech is looking for a highly talented and self- motivated R&D Engineer / Mechanical Engineer to join it in advancing the technological world through innovation and creativity. Job Title: R&D Engineer / Mechanical Engineer Job ID: 1626464BR Position Type: Full Time with HCLTech Location: Irvine, CA ( Onsite ) Role/Responsibilities Good in SolidWorks (1 to 2 years) Windchill Change management experience Medical Device Product development Validation & Verification (V&V) Good in communication and interpersonal skills Qualifications & Experience Minimum Requirements Bachelor's degree in relevant field Pay and Benefits Pay Range Minimum: $40.38 per hour Pay Range Maximum: $47.00 per hour HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to ****************** for investigation. Compensation and Benefits A candidate's pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year. How You'll Grow At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.

Solidworks Designer | Yorba Linda, CA Contract 3-4 Months (CAN BE REMOTE OR HYBRID) **Must have 3D Design Solidworks Experience to be considered** Perform detailed design of orthodontic products from engineering input. Create and modify Solidworks drawings from 3d models. Must be capable of translating performance requirements along with general concepts into a functional and manufacturable design. Must be able to: Take engineering concepts, and create designs in Solidworks. Create 3D model using detail drawings Create assembly drawings from engineering solid models. Perform tolerance analysis as required. Review and identify problems with drawings. Must have knowledge of PDM professional and checking files in and out and managing versions and revisions. Successful Candidate will have: SolidWorks 3D Modeling (Mid to Advanced User) 2016 or newer Familiar with design tables or multiple configurations Experience working in a PDM environment Experience in the design of medical or dental devices. Design experience with the following types of parts and detailed knowledge of the associated process is desirable: Plastic and ceramic parts Machined metal parts Brazed and welded assemblies Investment Cast parts Metal Injection Molded parts

My client is an innovative medical technology company with a non-invasive product for chronic disease, including neurological disorders. Due to recent growth, they are seeking a Principal Firmware Engineer to drive improvements on new projects as well as sustaining technology. This role offers the chance to join a rapidly growing, innovative team and to be part of an industry-changing solution. The Principal Firmware Engineer will join the existing product development team, and will act primarily as an individual contributor, while also exercising a leadership role to provide support, mentorship and technical leadership to more junior engineering team members. To be the Principal Firmware Engineer, you will need: A BS or MS in computer science, Computer Engineering or Electrical Engineering 10+ years of firmware engineering experience, specifically within low-power/small footprint design Technical experience including microcontrollers ARM Cortex (M0, M3, M4) ISO13485 C/Linux/Zephyr/free RTOS programming skills Expertise with radio/RF technology, including WiFi, NFC, BTLE, LTE/5G and cellular modem Cross-collaboration ability, and strong communication skills This role offers a competitive salary, comprehensive health benefits and 401k. It based in the San Francisco Bay Area. If the Principal Firmware Engineer role sounds like you, please click apply now or drop me a message. Share with your network too, if this is not quite right for you but could be perfect for someone you know!

80Twenty is a boutique marketing recruitment agency that connects high-growth companies with exceptional candidates. Want to build technology that truly moves the needle in healthcare? Join a fast-scaling, profitable healthcare services company - independently grown and not VC-backed - on a mission to make healthcare simpler, smarter, and more human! Our client is a healthcare tech and services company based in San Francisco, combining clinical expertise, operational excellence, and modern engineering to reshape how people experience care. From personalized medication management and transparent pharmacy pricing to community-based chronic care support, we're building a system that empowers both patients and providers. This is a fully onsite role based in San Francisco, CA. Candidates must be located within 30 miles of San Francisco. The standard schedule is Monday-Friday, 9am-7pm and may vary depending on business needs and role responsibilities. What the role looks like As a Staff Software Engineer, you'll help accelerate our product's reach and retention by building the systems that power acquisition, activation, and monetization. Working cross-functionally with engineering, product, design and data, you'll own high-leverage projects that directly shift growth metrics. In this role you will: Architect and deliver features spanning frontend, backend, and data infrastructure to drive conversion, engagement, and retention. Build and refine reliable event pipelines, identity frameworks, and attribution systems that power data-driven growth decisions. Collaborate with design to rapidly prototype and iterate high-performance landing experiences and lean tools for capturing user intent. Partner with product and data teams to isolate key growth hypotheses, test them quickly, and translate results into actionable learnings. Bring full-stack fluency (frontend and backend) along with a strong product mindset-being comfortable with ambiguity and shipping high-quality work at pace. You might be a great fit if you Have 5+ years of delivering production web software with measurable business impact. Are comfortable working across the stack: backend APIs and infra (auth, cookies, HTTP/CDN) and enough frontend to iterate user-facing flows. Have owned event instrumentation end-to-end (schema design, tag management, server-side forwarding). Understand SEO fundamentals (Core Web Vitals, crawlability, structured data). Are fluent in SQL and Python. Have strong product instincts: you can turn vague growth ideas into minimal, testable launches and iterate fast. Are familiar with GTM tools, ad pixels, and analytics frameworks for growth work. Nice-to-haves Mobile growth experience-deep linking, install attribution, web ↔ app journeys. Experimentation design expertise-know how to set up sound A/B tests, understand power and sequential testing risks. Exposure to multi-touch attribution or MMM frameworks and ability to automate campaign hygiene/data QA. Why join us? Top-of-market compensation plus meaningful equity-your effort helps shape the company. Join a team of high-caliber, mission-driven engineers, designers, and operations leaders who value humility, excellence and empathy. Be part of a profitably growing company-not VC-backed-which gives you more direct influence on outcome and culture. A vibrant office in downtown San Francisco (just steps from BART/Muni) built for in-person collaboration and energetic teamwork. Rich benefits including comprehensive medical/dental/vision, 401(k) match, unlimited PTO, wellness perks, and a subscription to experience the same care our patients do. If you're excited to apply your engineering expertise to meaningful healthcare infrastructure - and want to join a company that values autonomy, sustainability, and impact - we want to hear from you! Base salary: $250k-300k DOE + generous equity and benefits

About CoFlo CoFlo Medical's core annular flow devices reduce drug delivery injection forces by >200x, unlocking high-concentration, high-viscosity delivery beyond 1,000cP. CoFlo is collaborating with biopharmas to develop high-dose combination products that enable low-cost, less-frequent, and at-home treatment. Founded out of MIT and venture-backed, our team is reimaging healthcare with the mission of increasing patient access to life-saving therapies. What You'll Do You'll join our team as a Senior or Principal Device Engineer on the journey from early stage to FDA-ready device. You will lead and execute a wide range of device engineering responsibilities to enable CoFlo's progression through proof of concept, manufacturing scaleup, first-in-human, submission, and marketing. You will contribute to delivery devices across modalities, from large- and small-volume subcutaneous delivery to intravitreal injections and more. Your responsibilities will include: Drive device design from user needs through design freeze Organize and execute verification testing, human factors, and risk mitigation Manage vendor selection, tooling, sterilization, and packaging development Author data packages and documentation for regulatory submissions Requirements BS or higher in related field >5 years of experience in medical devices Desire to work in a fast-paced, high-agency environment Proven track record in most or all of the following: Design Controls and Risk Management, Design Transfer, Vendor Management (CRO, CMO, testing, etc.), User Needs and Human Factors Engineering, Verification and Validation Experience with needle-based injection device systems (Bonus) Literacy in specific needle-based injection system standards (ISO 11608, 11040, 10993, 11135) (Bonus) Startup or small-team experience What We Offer An opportunity to make a visible impact on a meaningful medical device and to grow with a fast-paced company. We also offer competitive salaries, early-employee equity, 401(k), health, dental, and vision insurance. Title will be commensurate with experience.

The Fiber Optic R&D Engineer will have experience in optical fiber technologies for medical device applications. Ideal candidate will possess knowledge of fiber processing techniques and the ability to develop and optimize manufacturing processes to enhance product performance, reliability, and manufacturability. Additionally, The Fiber Optic R&D Engineer will use engineering knowledge to design, develop, verify and validate product designs in support of company's strategic plan. Contribute as part of a cross‐functional team in product design and development, process development and optimization, and verification & validation testing to support product transfer to manufacturing. Responsibilities: Responsibilities: Process Development: Through hands-on technical execution, develop, optimize, and validate optical fiber manufacturing processes, including polishing, cleaving, splicing, ferrule inspection, coupler / combiner / splitter assembly, glass processing, and sensor fabrication. Supports with efforts to scale processes from development to full scale manufacturing. Equipment Utilization: Operate and maintain state-of-the-art fiber processing equipment, including Fujikura cleavers and splicers, Domaille polishers, glass processors, fiber inspection scopes, and Keyence microscopes. Technical Expertise: Provide knowledge of various fiber types (single-mode and multimode), fiber coatings, clad thicknesses, and materials. Ensure compliance with industry standards and best practices. End Face Processing: Design, optimize, and implement end face fiber processing techniques. Connector Knowledge: Demonstrate knowledge in common fiber connectors, including single fiber ceramic ferrules, multi fiber ferrules (MT), and linear ferrule arrays, to enhance assembly and reliability. Demonstrate competence in ferrule polishing and polishing recipe development. Testing and Validation: Demonstrate knowledge of optical test configurations for launching light into fibers, measuring light transmission, and conducting performance evaluations. Analyze data to drive continuous improvement initiatives. Performs or manages process validations (IQ/OQ, OQ, PQ). Perform Verification and Validation (V&V) and may draft protocols/reports for approval. Conducts testing to verify that the design meets the engineering specifications. Collaboration: Work closely with cross-functional teams, including R&D, quality assurance, and production, to ensure alignment on process development goals and product specifications. Documentation and Reporting: Prepare and maintain detailed documentation of processes, test results, and validation protocols. Present findings to stakeholders and contribute to technical reports. Draft design transfer documentation. Prepare documentation to support quality system for design functions (project plans, concept document, FMEA, design input, test results, drawings, etc.). Prepare technical documentation, including manufacturing instructions, test methods, drawings, BOMs, protocols, and reports to support design control activities. Document engineering work in compliance with the company's quality system. Continuous Improvement: Evaluate current catheter manufacturing practices and identify those needing improvement. Use lean manufacturing techniques to maximize manufacturability. Statistical Analysis: Use Six Sigma Methodology (DMAIC or DMADV) and tools including Minitab, FMEA, Fishbone, Process Mapping, etc.Compiles and analyzes data to identify root causes, draw conclusions, generate solutions, and generate reports. Risk Mitigation: Identifies hazards and mitigates risk associated with identified hazards in Design and Process FMEA. Assess failure modes and conduct technical risk analysis. Design: Able to design process fixtures and tools. Support the development of specifications for tooling and fixturing according to company quality standards. Qualifications: Education: Engineering degree desired or equivalent experience in related job field Required Experience: 0-2 yrs (Engineer I) or 2+ yrs (Engineer II) Biomedical product / medical device development or fiber optic device assembly / development experience. Working knowledge of mechanical design principles and FDA regulated medical device design controls a plus. Proficient in CAD software, preferably SolidWorks. Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred. Understanding of IEC60601 requirements/constraints for mechanical system design is preferred. Hands-on experience managing suppliers and/or contract manufacturers a plus. Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) preferred. Experience with fiber optic processing including cleaving, tapering, fusion splicing, and terminating / polishing ferrules. Knowledge, Skills, and Abilities: Proficient in Risk Management according to ISO 14971. Knowledge of ASME Y14.5 GD&T. Excellent interpersonal, communication, and documentation skills are required. Takes initiative and acts quickly to drive solutions. Strong interpersonal, organizational and communication skills. A flexible team player, focusing on shared goals with a positive results‐oriented attitude.

Honey Health is the all-in-one AI back office for primary and specialty care. Our AI agents autonomously handle core back-office jobs, such as aggregating patients data, processing orders and prescriptions, automating prior authorizations, triaging faxes and referrals, and managing RCM(revenue cycle management). Organizations using Honey frequently cut administrative costs in half while improving staff/patient satisfaction and increasing revenue. Built with enterprise-grade security and privacy, our platform delivers real operational transformation. About the Role Honey Health is seeking a Senior/Staff Software Engineer to build leading AI Agent systems that transform healthcare operations. In this role, you will design and implement the infrastructure for training and deploying highly useful AI Agents in healthcare. Our team's mission is to create seamless, robust platforms for AI Agents - enabling them to operate at scale and perform complex tasks safely and autonomously. You'll work closely with AI researchers, product teams and operation teams to translate cutting-edge technical research into impactful healthcare applications, automating back-office works and improving patient care. The ideal candidate is passionate about being the builder of AI Agents (especially in healthcare) and relentless in pursuing high-quality, safe, and beneficial AI systems. This is a full-time role based in the U.S., offering the opportunity to lead innovation at the intersection of AI and healthcare. Is This You? You're fired up about Agentic AI and ready to help shape the future of healthcare. You're joining at the perfect moment to build transformative AI agents, and you're here to learn fast, contribute boldly, and grow into a leader in this space. You're deeply driven to make a meaningful impact - shaping team culture at Honey, redefining value for healthcare providers and patients, and pushing the boundaries of innovation in one of the most impactful industries. You don't just solve problems - you tackle the hardest ones with ambition and drive. You bring relentless energy, even in the face of complexity, always aiming for excellence when it matters most. You bring infectious energy and initiative - sparking bold ideas, asking the right questions, and inspiring the team to explore ambitious paths in a fast-moving, open and exploratory environment. If these describe you, we should definitely talk. In this role, you will: Architect and invent next-generation AI agent infrastructure to train and deploy healthcare AI agents, ensuring the platform is efficient, reliable, and scalable for large-scale workloads and healthcare production environments. Integrate the latest LLM advancements and in-house research into the agent platform, leveraging generative AI and reinforcement learning to continuously enhance agent capabilities. Prototype and integrate AI agents with real healthcare data and services to enable reliable, safe automation in complex workflows (e.g. automating administrative tasks), and design secure sandboxed execution environments to ensure robust operations. Collaborate with healthcare experts to turn novel AI research into practical features, and with pilot customers and clinicians to validate and refine the value in healthcare. Uphold high standards in code quality, testing, and reliability, continuously improve processes & monitoring to deliver an excellent experience for healthcare users. You might thrive in this role if you: 8+ years of industry-related experience. Fueled by a vision to use AI as a force for innovation, care improvement, and system-wide change in healthcare. You've built cutting-edge AI and Agentic systems, ranging from tool-calling stacks to MCP-style frameworks, and bring hands-on experience with LangChain, context engineering, and RL-enhanced agents. Know how to build new things from 0-1 quickly, and then scale them 1,000,000x. Have a strong product mindset with a focus on quality and user impact, care about solutions being technically sound and improving end-user workflows, and have a knack for iterative improvement, testing, and delivering high-impact features. Committed to never settling - pushing limits through continuous improvement, precision, and a mindset to lead. Join us at Honey Health and apply your expertise and talent in AI agents to solve real-world healthcare challenges. You will be at the forefront of a new era where Agentic AI systems meaningfully improve healthcare - from reducing administrative burden to enabling better patient care - all while working with a team that values innovation, safety, and impact. We look forward to your curiosity, ownership, and drive in pushing the boundaries of what AI agents can do in healthcare. Apply now to shape the future of health with us.

R&D Sustaining Engineer | Medical Devices Compensation: $100k-$120k + bonus + benefits Employment: Full Time (This role is not eligible for visa sponsorship.) We are seeking an R&D Engineer who thrives in solving problems, improving products, and collaborating cross-functionally. This role focuses on supporting and improving existing medical device products - ensuring they remain reliable, compliant, and cost-effective throughout their lifecycle. You'll work closely with Manufacturing, Quality, Supply Chain, and Regulatory teams to troubleshoot issues, implement design changes, and drive continuous improvement efforts. What You'll Do Lead sustaining engineering projects focused on product improvements, cost reductions, and component updates Serve as a primary R&D partner to Manufacturing for troubleshooting and root cause analysis Implement and document design & process changes in compliance with regulated environments Support V&V testing, documentation, and engineering evaluations Contribute to change orders, labeling/IFU updates, and competitive product testing What You Bring Bachelor's degree in Mechanical, Biomedical, Electrical, or related engineering field 4+ years in a regulated industry; medical device experience strongly preferred Understanding of FDA, ISO, and GMP requirements Experience with design controls, risk management, and validation Strong problem-solving and project leadership skills Proficiency with SolidWorks and Microsoft Office / MS Project Familiarity with lean manufacturing or continuous improvement methodologies