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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. 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.

YEAR

Head of Operations and Manufacturing | California (Hybrid or Remote) | Full-Time POSITION SUMMARYThe Head of Operations and Manufacturing will own the end-to-end operational infrastructure required to bring our 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 RESPONSIBILITIESManufacturing & Production<ul><li>Lead selection and onboarding of contract manufacturing partners with Class II medical device experience, including RFQ, quality audits, contract negotiation, and ongoing management.</li><li>Own design transfer and manufacturing transfer, working with engineering on DFM principles, Device Master Record (DMR) requirements, and production readiness.</li><li>Establish production planning, forecasting, and capacity management for V&V builds, pilot production, and volume manufacturing.</li><li>Drive continuous improvement in yield, quality, and cost while maintaining FDA and ISO compliance.</li><li>Oversee pilot runs and scale-up, including process validation (IQ/OQ/PQ) and manufacturing controls.</li></ul>Supply Chain & Procurement<ul><li>Build and manage the end-to-end supply chain, including component sourcing, supplier qualification, and inventory management per FDA purchasing controls.</li><li>Develop supplier relationships and negotiate terms while ensuring supply continuity, traceability, and risk mitigation.</li><li>Implement inventory planning to balance working capital with service levels, including buffer strategies for Year 1 launch.</li><li>Monitor and mitigate supply chain risks: component shortages, single-source dependencies, geopolitical factors, and logistics disruptions.</li></ul>Quality & Regulatory Compliance<ul><li>Maintain and improve the ISO 13485-certified QMS in partnership with the quality and regulatory team, ensuring FDA 21 CFR Part 820 compliance.</li><li>Support 510(k) submission activities related to manufacturing, including process validation documentation, DMR development, and device history records (DHR).</li><li>Define incoming inspection, in-process controls, and final product testing consistent with the risk management file.</li><li>Manage product certifications for a Class II device, including FDA registration, UDI compliance, and applicable international requirements.</li><li>Lead root cause analysis and CAPA for quality issues, ensuring post-market surveillance compliance.</li></ul>Fulfillment & Logistics<ul><li>Design the direct-to-patient fulfillment strategy, including 3PL selection with FDA-cleared Class II device experience.</li><li>Establish logistics and distribution for nationwide shipping of a regulated device with chain-of-custody and traceability.</li><li>Develop returns, replacement, and warranty processes that balance patient experience, cost, and compliance.</li></ul>Team & Organizational Development<ul><li>Start as an individual contributor who executes hands-on, then build and lead the operations team through 510(k) clearance and commercial launch.</li><li>Establish operational metrics and dashboards for manufacturing, supply chain, and quality performance.</li><li>Partner with finance on cost modeling, COGS optimization, and operational budgeting.</li><li>Collaborate cross-functionally with engineering, software, regulatory, and commercial teams.</li></ul> QUALIFICATIONS<ul><li>7-12 years in manufacturing, operations, or supply chain, with 3-5+ years in medical devices (Class II preferred), wearables, or regulated hardware.</li><li>Experience managing contract manufacturers for regulated medical devices, preferably in Asia and/or domestically.</li><li>Experience at or with CMs/EMS providers (Flex, Jabil, Celestica, Plexus, Sanmina) in Class II medical device or wearable programs is a strong plus.</li><li>Track record of design transfer and scaling production from pilot to volume for regulated products.</li><li>ISO 13485 and FDA 21 CFR Part 820 experience required.</li><li>Familiarity with the 510(k) process and manufacturing documentation (process validations, DMR/DHR) strongly preferred.</li><li>Bachelor's in Engineering, Supply Chain, Operations, Biomedical Engineering, or related field; MBA or advanced degree a plus.</li><li>Based in California or travel up to 25%.</li></ul>COMPENSATION<ul><li>Base Salary: $160,000 - $210,000 USD</li><li>Performance Bonus: Tied to company milestones and personal objectives</li><li>Equity: Early-stage stock option grant with meaningful ownership</li><li>100% Employer-Paid Healthcare: Medical, dental, and vision</li><li>Additional Benefits: 401(k) with company match, flexible PTO</li></ul>WORKING CONDITIONS:<ul><li>May on occasion be exposed to loud sounds and distracting noise levels, such as from office equipment.</li><li>The ability to lift up to 30lbs</li><li>Use of computers and technology</li></ul> Here at Canon Recruiting, People are our priority, and we are committed to Include Diversity in every segment of who we are. It is only through our Diversity; we are made a stronger organization and increase our ability to provide top tier candidates that our clients have come to know Canon for. We have an inclusive environment all employees are celebrated for their unique differences. The different perspectives and experiences of our workforce give us the competitive advantage that is essential for success in an ever-changing market. By promoting inclusion with the same enthusiasm, we devote to quality and competency and using the experience from a diverse assortment of backgrounds and experiences, Canon can improve the services and value we deliver to clients, employees, and customers. At Canon, Diversification and Inclusiveness are much more than a corporate ambition; they are a critical component in our daily corporate life. Canon Recruiting is committed to a diverse and inclusive workplace. Canon Recruiting is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. The pay range for this position is listed above. Base pay information is based on market location. We will consider for employment qualified applicants with arrest and conviction records. Our range of benefits may include health care and 401(k) savings plans. For individuals with disabilities who would like to request an accommodation, please email hr@canonrecruiting.com

Canon Recruiting Group

Head of Operations and Manufacturing - Medical Device (Hybrid or Remote)

Biomedical Engineering

Blood Pressure

Budgeting

Business Administration

Capacity Management

Code of Federal Regulations

Continuous Improvement

Contract Management

Contract Manufacturing

Contract Negotiation

Corrective and Preventative Action (CAPA) Systems

Cost Modeling

Cost of Goods Sold (COGS)

Cross-Functional

Diversity

Documentation

FDA (Food and Drug Administration)

Financial Modeling

Forecasting

Healthcare

ISO (International Organization for Standardization)

Inventory Management

Inventory Planning

Leadership

Lift/Move 30 Pounds

Logistics

Manufacturing

Manufacturing Operations

Manufacturing/Industrial Processes

Market Tracking

Medical Equipment

Metrics

Negotiation Skills

Office Equipment

Onboarding

Organizational Development/Management

Process Control Engineering

Process Improvement

Process Manufacturing

Process Validation

Procurement Management

Product Management

Product Testing

Production Planning

Production Volume

Productivity Management

Purchasing/Procurement

Quality Management

Regulations

Reporting Dashboards

Request for Proposals (RFP)

Risk Management

Root Cause Analysis

Supply Chain

Supply Chain Operations

Surveillance

Team Building

Team Lead/Manager

Third-Party Logistics (3PL)

Traceability

Validation Documentation

Vendor/Supplier Relations

Vendor/Supplier Sourcing

Wearables

Willing to Travel

Crelate

FULL_TIME

Acting as a representative for either our contract or brokerage carriers, you will be responsible for soliciting, underwriting, marketing, and ultimately securing coverage for our business enterprises within the excess and surplus lines marketplace. In today's rapidly evolving business landscape, embracing cutting-edge technology is not just a choice but a necessity for staying relevant in the marketplace.

Hours: 8:30-5:00 Local TimeLocation: Remote or hybrid, depending on your areaCompensation: $65,000 - $150,000Who We Are:Welcome to USG, a distinguished national wholesale broker and managing general agent (MGA) with a prominent presence across the nation. Our extensive network spans over 400 different markets and we proudly write business in all 50 states.USG has consistently earned recognition for our excellence, being ranked as a 5-star MGA by Insurance Business of America for four consecutive years. Moreover, we take pride in our continuous acknowledgment as a Top Insurance Workplace over the past five years, as voted on by our current team members.We at USG prioritize fostering a collaborative and mentoring-focused environment. We recognize the pivotal role each team member plays in our success, emphasizing hands-on training to ensure everyone feels comfortable and confident in their role. At USG, we actively empower our team members to bring their authentic selves to the workplace, recognizing that fostering diversity is essential for a thriving, creative, and dynamic professional environment.In today's rapidly evolving business landscape, embracing cutting-edge technology is not just a choice but a necessity for staying relevant in the marketplace. Our in-house IT development and support teams expertly oversee and manage both our proprietary and third-party systems, ensuring our sales operations stay at the forefront of technological advancement.Embark on your professional journey with USG, where it's more than just a job, it's a vibrant and supportive community committed to nurturing your success.The Role ItselfIn this role, you will engage directly with our primary customer, the independent Property and Casualty Retail Agent. Acting as a representative for either our contract or brokerage carriers, you will be responsible for soliciting, underwriting, marketing, and ultimately securing coverage for our business enterprises within the excess and surplus lines marketplace. Effective relationship-building skills are crucial to collaborate with our partners, aiming to cultivate a profitable book of business.Responsibilities include:<ul><li>Develop and maintain strong relationships with retail agents to drive new business opportunities and grow an assigned book of business.</li><li>Evaluate, underwrite, and broker risks by analyzing coverage needs, exposures, and market conditions to deliver competitive solutions.</li><li>Market submissions to carrier partners and negotiate terms, pricing, and coverage to achieve optimal outcomes for clients and the organization.</li><li>Manage the full lifecycle of accounts, including new business, renewals, endorsements, and servicing needs.</li><li>Collaborate with internal teams and carrier partners to ensure timely processing, placement, and policy issuance.</li><li>Maintain a high level of responsiveness and professionalism in all communications with agents, carriers, and internal stakeholders.</li><li>Monitor market trends, carrier appetite, and industry developments to identify new opportunities and stay competitive.</li><li>Ensure compliance with company guidelines, underwriting standards, and regulatory requirements.</li><li>Accurately document account activity and maintain records within agency management systems.</li><li>Contribute to the growth and profitability of the business by meeting or exceeding production and revenue goals.</li></ul>What We Are Looking For:To perform this job successfully, an individual must be able to demonstrate consistent competency in each essential job duty.<ul><li>3 years of either wholesale broker/MGA or carrier experience, excess & surplus lines preferred</li><li>Must be a sales driven “people person” who likes to establish new relationships while learning communication strategies and sales methods.</li><li>Energetic, self-motivated, goal oriented, and able to thrive in a team environment.</li><li>Strong knowledge and experience of property and casualty insurance including: coverages, rating, terminology and technical procedures.</li><li>Certificates, Licenses, Registrations: P&C License required. E&S License preferred, but not required.</li><li>Must be experienced in Microsoft Suite, and other Windows based software applications.</li><li>Ability to quickly learn new programs and applications.</li></ul>What USG has to offer:<ul><li>Company-paid benefits: Short-Term Disability, Long-Term Disability, Basic Life, AD&D, and Team member Assistance Program</li><li>Medical, Dental, Vision, and Life</li><li>401K Retirement Plan</li><li>Flexible Spending Account</li><li>Dependent Care</li><li>Tuition Reimbursement</li><li>A week of hands-on, in-person training to meet our corporate team</li><li>Access to 24/7 virtual training through USG University</li><li>Outstanding Company Holiday Schedule and Generous Paid Time Off Package</li><li>Potential for exponential growth in the company</li></ul>Join Us!If you're excited about the wholesale industry and are ready to contribute your skills and passion to a dynamic team, USG Insurance Services is the perfect company for you. We're looking for individuals who share our entrepreneurial spirit and are eager to help us shape the future of wholesale insurance.Visit https://www.usgins.com/index.aspx to learn more about our work, our team, and the opportunities we have available.Powered by JazzHR

USG Insurance Services, Inc.

Production Underwriter/Broker

Brokerage

Business Growth

Business Writing

Community Support

Corporate Compliance

Entrepreneurship

Establish Priorities

Exceeded Sales Goal

Insurance

Interpersonal Skills

Lead Generation

Leading Edge Technology

Maintain Compliance

Market Trend Analysis

Marketing

Mentoring

Microsoft Product Family

Microsoft Windows Operating System

Needs Assessment

Pricing

Profit & Loss

Property and Casualty Insurance

Record Keeping

Records Management

Regulatory Requirements

Retail

Risk Analysis

Sales

Sales Operations

Sales Prospecting

Sales Strategy

Team Player

Technical Support

Time Management

Underwriting

Wholesale Industry

partner JazzHR

ADAPTED_NOW

In this role, you will assist and lead, as required, the efforts to control and improve processes and systems currently in use, and to bring new technologies to Fender in the search for Better Product, considering the Best Time to process, adhering to the current and new Environmental laws to continue delivering product to customers as scheduled. Fender Musical Instruments Corporation (FMIC) is one of the world’s leading musical instrument manufacturers, marketers and distributors, whose portfolio of brands includes Fender®, Squier®, Gretsch®, Jackson®, EVH®, Charvel® and Groove Tubes®, among others.

Fender Musical Instruments Corporation is a world-famous brand with offices across the globe. Fender was born in Southern California and has built a worldwide influence beyond the studio and the stage. A Fender is more than an instrument; it’s a cultural symbol that resonates globally.We are searching for a Manufacturing Engineer to join our team. In this role, you will assist and lead, as required, the efforts to control and improve processes and systems currently in use, and to bring new technologies to Fender in the search for Better Product, considering the Best Time to process, adhering to the current and new Environmental laws to continue delivering product to customers as scheduled.  You will also be responsible for creating systems (manual and automation systems) and able to trouble shoot equipment and product diligently.Essential Functions: <ul><li>Analyze and optimize production line workflows to ensure balanced task distribution, applying time and motion studies to validate standard times and takt time</li><li>Collaborate with production and operations teams to implement changes and sustain balanced line performance</li><li>Design more efficient systems to integrate workers, machines, and materials through data collection on time studies</li><li>Establish processes and procedures to optimize cost and quality of manufacturing methods</li><li>Lead and coach A3 problem solving efforts related to process opportunities</li><li>Identify, develop, and implement new technologies in manufacturing processes, with a focus on automation and process improvement initiatives</li><li>Support and lead automation projects, including evaluation, implementation, and optimization of automated systems within the factory</li><li>Develop and support CNC programming activities to improve machining efficiency and consistency</li><li>Design and implement fixtures and tooling to improve repeatability, quality, and throughput</li><li>Support and/or program robotic systems for manufacturing applications (as applicable)</li><li>Assist in the documentation of regulatory information related to new processes or process changes (EWI, EVAQ, SWI, paint recipes, and process control formats)</li><li>Provide technical support to track data for main detractors of yield and drive corrective actions</li><li>Implement, monitor, and maintain process control and data tracking systems in collaboration with Process Technicians and Engineering leadership</li><li>Participate in and promote process characterization and continuous improvement projects</li><li>Additional duties as assigned</li></ul>Qualifications: <ul><li>BA/BS in Manufacturing, Mechanical, Industrial, Electrical, or related Engineering discipline</li><li>Minimum of two to four (2–4) years of experience in a manufacturing engineering role</li><li>Experience with automation systems and implementation in a manufacturing environment</li><li>Hands-on experience with CNC programming and machining processes</li><li>Experience with fixture design and tooling development</li><li>Exposure to or experience with robot programming strongly preferred</li><li>Experience working with wood and/or aluminum manufacturing processes is a plus</li><li>Proficiency in engineering and manufacturing software (AutoCAD, SolidWorks, MasterCAM, Minitab, SAP, MS Office)</li><li>Cross-functional experience in manufacturing processes</li><li>Experience with line balancing and process optimization projects</li><li>Working knowledge of Lean Manufacturing / Six Sigma methodologies (Green Belt preferred)</li><li>Strong problem-solving skills with the ability to analyze data and drive decisions</li><li>Bilingual English/Spanish is a plus</li></ul>About Fender Musical Instruments:Fender Musical Instruments Corporation (FMIC) is one of the world’s leading musical instrument manufacturers, marketers and distributors, whose portfolio of brands includes Fender®, Squier®, Gretsch®, Jackson®, EVH®, Charvel® and Groove Tubes®, among others. For more information, visit <a href="http://www.fender.com/" rel="nofollow">www.fender.com</a>. FMIC offers a competitive benefits package which includes medical, dental, 401(k), paid time off, and an equipment purchase program to help you get the band back together. Fender Musical Instruments Corporation is an equal opportunity employer and considers qualified applicants for employment without regard to race, gender, age, color, religion, disability, veterans’ status, sexual orientation, or any other protected factor.Fender is required by law in certain jurisdictions to include a pay scale in the job posting for this position.  “Pay scale” means the salary or hourly wage range that Fender reasonably expects to pay for this position; it is neither a promise nor a guarantee of the compensation that the successful candidate will receive.  The pay scale for this position takes into account the wide range of factors that Fender considers in making compensation decisions, including, without limitation: skill set, experience, training, licensure and certifications, and other business and organizational needs.  If this is a remote position, the pay scale disclosed herein may be adjusted further based upon the applicable geographic differential associated with the location from which the successful candidate will work.  Please note that it is not typical for a Fender employee to be at or near the top of the pay scale for their role – especially as a new hire – and compensation decisions are dependent on the facts and circumstances of each case.  Subject to the foregoing, the current pay scale for this position is $75,000 to $85,000 per year.#LI-Onsite

Fender

Manufacturing Engineer

Fender Jobs

Hybrid Production Jobs in Costa Mesa, CA

Hybrid Production Jobs in Costa Mesa, CA

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Hybrid Production Jobs in Costa Mesa, CA

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