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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

Our leading brands include the iconic Goulds Pumps (with more than 175 years of history), Anhydro, APV, Bornemann, Bran+Luebbe, C’treat, Engineered Valves, Gerstenberg Schröder, Habonim, Johnson Pump, Lightnin, Philadelphia, Plenty, PRO Cast, Rheinhütte, Seital Separation, Stelzer, Svanehøj, Tigerholm, Uutechnic, VIDAR, Waukesha Cherry-Burrell. Through operational execution, innovation, and disciplined capital deployment, including strategic acquisitions such as SPX FLOW, ITT partners with its customers to deliver enduring solutions to the key industries that underpin our modern way of life.

About ITT::
ITT Inc. (NYSE: ITT) is a diversified global leading manufacturer of highly engineered critical components and customized technology solutions serving the flow, aerospace and defense, transportation, industrial, and energy markets. Through operational execution, innovation, and disciplined capital deployment, including strategic acquisitions such as SPX FLOW, ITT partners with its customers to deliver enduring solutions to the key industries that underpin our modern way of life.  Headquartered in Stamford, Connecticut, ITT has a market cap of roughly $20 billion and employs more than 15,000 people across 40 countries and serves customers in approximately 125 countries. Following the acquisition of SPX FLOW, the company is expected to generate $5.4 billion in annual revenue. Our businesses are organized in three distinct segments, each based around our core engineering DNA:  Flow Technologies: A global leader in, providing a broad portfolio of pumps, valves, mixing and agitation equipment, heat transfer, homogenizers, separation, water and wastewater treatment, and engineered process solutions.Our leading brands include the iconic Goulds Pumps (with more than 175 years of history), Anhydro, APV, Bornemann, Bran+Luebbe, C’treat, Engineered Valves, Gerstenberg Schröder, Habonim, Johnson Pump, Lightnin, Philadelphia, Plenty, PRO Cast, Rheinhütte, Seital Separation, Stelzer, Svanehøj, Tigerholm, Uutechnic, VIDAR, Waukesha Cherry-Burrell. Motion Technologies: A global leader in brake pads (ICE and electrified brake pads) and shock absorbers (energy absorption solutions) for transportation applications. Our leading brands include Friction Technologies, KONI and Axtone. Connect and Control Technologies: A leader in critical applications for the aerospace, defense and industrial markets, including harsh environment connectors and control components. Our leading brands include ITT Cannon, Enidine, Aerospace Controls and kSARIA. 

Position Summary:
The Engineering Applications Analyst will be the primary connection between the IT department and the Engineering community. This role involves acting as a mediator, facilitator, and advocate for the customer to resolve issues effectively. Furthermore, the analyst will support projects within the PLM/PLD transformation portfolio that aim to reshape the current landscape.The analyst will collaborate closely with Engineering leadership to identify opportunities for productivity improvement and support strategic initiatives that require IT support. They will implement suitable solutions and periodically meet with engineering leadership to review business strategies and the availability of software tools. This ongoing assessment will help determine the most efficient and cost-effective methods to meet business requirements. The analyst will develop, test, install, and deploy necessary software applications. Solutions may involve various software technologies, including commercial off-the-shelf (COTS) solutions, new code development, modifications to existing modules, and configuration or package implementation.Additionally, the Engineering Applications Analyst will leverage business acumen, technical expertise, and knowledge of available software to deploy and enhance the PTC Windchill platform, particularly PDMLink. The Manager of Technical Applications will also provide support for all other Engineering tools, which include, but are not limited to, PTC Creo, related PTC software, ANSYS Fluids, and Mechanical applications.

Essential Responsibilities:
<ul><li style="margin:0in 0in 0in 24.75pt">Provide technology expertise relative to engineering and IT.</li><li style="margin:0in 0in 0in 24.75pt">Support uptime of engineering software and systems – target 99.9% of 24/7/365.</li><li style="margin:0in 0in 0in 24.75pt">Help manage support agreements with Engineering software vendors.</li><li style="margin:0in 0in 0in 24.75pt">Build and support a standard engineering app as much as possible with rarer or without customizations.</li><li style="margin:0in 0in 0in 24.75pt">Install and configure specialized software where no network deployment is available.</li><li style="margin:0in 0in 0in 24.75pt">Implement upgrades, enhancements, and/or new systems as appropriate within the Engineering System and by business requirements and goals.</li><li style="margin:0in 0in 0in 24.75pt">Assist with pertinent input to the IT budget for Engineering IT systems, including allocating software maintenance costs to the business units.</li><li style="margin:0in 0in 0in 24.75pt">Collaborate with other team members who provide localization requirements.</li><li style="margin:0in 0in 0in 24.75pt">Maintain awareness of new technology and implement upgrades, enhancements, and new solutions as appropriate.</li><li style="margin:0in 0in 0in 24.75pt">Assist with pertinent input to Enterprise IT to guide company standards for engineering hardware and software to ensure compatibility, adequate performance, and consistency with department and corporate goals.</li><li style="margin:0in 0in 0in 24.75pt">Be capable of leading end-to-end design workshops, providing knowledge of best practices, and transforming business processes through advising and guiding business users.</li><li style="margin:0in 0in 0in 24.75pt">Assume partial project management responsibility where needed.</li><li style="margin:0in 0in 0in 24.75pt">Proactively work and mitigate any unforeseen risks.</li><li style="margin:0in 0in 0in 24.75pt">Recommend the most appropriate and scalable long-term solutions for business.</li><li style="margin:0in 0in 0in 24.75pt">Help develop training documentation for end users.</li><li style="margin:0in 0in 0in 24.75pt">Act as a business partner and create long-term relationships with key business users and stakeholders.</li><li style="margin:0in 0in 0in 24.75pt">Other duties as assigned by management.</li></ul>

Position Requirements:
<ul><li style="margin:0in 0in 0in 24.75pt">Apply technical knowledge of engineering data management and engineering expertise in deploying and using PTC Windchill PDM Link 10.2 or above.</li><li style="margin:0in 0in 0in 24.75pt">Develop test data and analyze problems in supported engineering platforms.</li><li style="margin:0in 0in 0in 24.75pt">Support technical direction to other engineering IT team members.</li><li style="margin:0in 0in 0in 24.75pt">The candidate must be a green card holder or have American citizenship.</li><li style="margin:0in 0in 0in 24.75pt">Bachelor's Degree preferred, and 10+ years of related experience or an equivalent combination of education and experience.</li><li style="margin:0in 0in 0in 24.75pt">Demonstrated extensive knowledge of the PTC Windchill platform, including context management, user management, access control rules (ACL), object types, lifecycle management, report creation, and workflow administration.</li><li style="margin:0in 0in 0in 24.75pt">Experience with PTC Windchill CadWorker.</li><li style="margin:0in 0in 0in 24.75pt">Knowledge of Java and JavaScript is a plus.</li><li style="margin:0in 0in 0in 24.75pt">Experience with PTC Windchill file vaults and replication a plus.</li><li style="margin:0in 0in 0in 24.75pt">Experience providing performance tuning, problem analysis, upgrades, and system administration for PTC Windchill, a plus.</li><li style="margin:0in 0in 0in 24.75pt">Analyze, diagnose, and resolve computing problems involving system hardware, third-party software, and operating system software.</li><li style="margin:0in 0in 0in 24.75pt">Maintain standard operating procedures and documentation.</li><li style="margin:0in 0in 0in 24.75pt">Strong analytical, communication, and interpersonal skills, with the ability to work effectively with technical and non-technical stakeholders.</li><li style="margin:0in 0in 0in 24.75pt">Ability to manage multiple priorities and meet deadlines in a fast-paced environment.</li><li style="margin:0in 0in 0in 24.75pt">Attention to detail and a commitment to data accuracy and integrity.</li><li style="margin:0in 0in 0in 24.75pt">Hybrid work environment with on-site and remote work (Full-Remote work can be considered).</li><li style="margin:0in 0in 0in 24.75pt">Occasional travel may be required for business needs such as workshops, training, partner meetings, or professional development.</li></ul>#LI-REMOTE#CCT1

Equal Pay Act Statement:
We aim to pay our ‘ITT’ers’ fairly and competitively in the locations that they live and work. Pay-for-performance is a principle that we believe in, and employees are rewarded based not only on ‘what’ they accomplish, but also on ‘how’ they reflect ITT’s values. ITT offers a competitive salary and robust total rewards package, such as health insurance, 401(k), short and long-term disability, paid time off, growth and developmental opportunities, and other incentive compensation programs. Specific benefits are dependent upon whether or not the position is part of a collective-bargaining agreement. The salary offered to a candidate is based several factors such as candidate experience and qualifications, location, as well as market and business considerations.

Equal Pay Act Range:
Annual salary range is from $115,100.00 to $171,900.00, plus benefits & incentive plan.

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Hybrid Engineering Jobs in Cucamonga, CA

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

Engineering Applications Analyst (Windchill) ITT Inc. - English US

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