Jobs in the United States

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UMB Staff
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…manuscripts and presenting studies; developing protocol manuals and data collection instruments; participating in field visits, responding to requests and questions from individuals,…
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Electrical Engineer
Markon
Niskayuna, NY
- $120,000 to $127,000 USD / year
Prepare and review electrical engineering specifications, design calculations, construction drawings, and project cost estimates.
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- $120,000 to $127,000 USD / year
Provide engineering support throughout the construction phase, including technical reviews, field coordination, and resolution of design-related issues.
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Senior Software Engineer
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Oklahoma City, OK
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Production Manager
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Dayton, MN
- $120,000 to $140,000 USD / year
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Associate Director, Supply Chain - Digital ERP COE (Remote)
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Remote, United States
Qualifications You Must Have:
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Senior Procurement Account Manager
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Structural Engineering Intern (Summer 2027)(Onsite)
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Principal Estimator
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Greenville, SC
At Fluor, we are proud to design and build projects and careers. We are committed to fostering a welcoming and collaborative work environment that encourages big-picture thinking, brings…
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Principal Estimator
Fluor Careers
Greenville, SC
At Fluor, we are proud to design and build projects and careers. We are committed to fostering a welcoming and collaborative work environment that encourages big-picture thinking, brings…
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TSI, Inc.
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Use keyboard and computer terminal to enter data into the SAP screens as required.
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Specialist, Electromechanical Engineer
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Salt Lake City, UT
…electro-mechanical systems, and electronic assemblies. Maintenance and design assistance of test sets required as…
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Specialist, Optical Engineer
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Carlsbad, CA
…validated optical components and assemblies. The work spans optical design, modeling, laboratory characterization, and integration, with responsibility for delivering technically sound…
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Lead, Optical Engineer
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Carlsbad, CA
Originate and evaluate optical design concepts for fiber optics, precision microscopy, and waveguides, and lead technology development through models, prototypes, and experiments. Connect…
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Supply Chain Analyst [Nashville, TN]
Aston Carter
Nashville, TN
- $27 to $30 USD / hour
…Chain Capacity Analyst plays a key role in enabling effective, data-driven decisions for a large and rapidly evolving distribution network. The role focuses on capacity planning,…
Added 1 min ago
AC
Supply Chain Analyst
Aston Carter
Nashville, TN
- $27 to $30 USD / hour
…Chain Capacity Analyst plays a key role in enabling effective, data-driven decisions for a large and rapidly evolving distribution network. The role focuses on capacity planning,…
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Applied AI Solutions Specialist
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Washington, DC
Design and test AI agents and multi-step workflows that use approved tools, data sources, and systems to complete clearly defined tasks with appropriate human oversight.
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Land & HOA Coordinator
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Apps Dev Intmd Programmer Analyst - Officer
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NY · New York
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Senior Practice Strategist
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…Director, Practice Model Strategy, this role contributes to the design of scalable practice model offerings, advisor teaming approaches, role strategies, and growth frameworks that help…
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Digital SAP S/4Hana Senior Data Architect (Remote)
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Partner with engineering, infrastructure, cloud, cybersecurity, data, and application development teams.

Kardion

Staff Manufacturing Engineer

Irvine, CA, United States

$110,000 to $125,000 USD / year

Apply on kardion.applytojob.com About employer

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Job details

Pay: $110,000 to $125,000 USD / year
Apply by: Feb 9, 2027
Experience: 5–10 years of experience in medical device development, manufacturing, and/or design transfer, ideally involving Class III or PMA-regulated products.
Posting language: English
Posted: Nov 11, 2026

Original job description

About Kardion Kardion is a cardiovascular medical device company developing next-generation mechanical circulatory support technology, with dual headquarters in Irvine, California, and Stuttgart, Germany. Every moment matters. Our team is building toward a future where circulatory support gives patients and clinicians more time, more options, and more certainty. Position Summary The Staff Manufacturing Engineer is responsible for leading the end-to-end execution of design transfer activities from R&D to commercial manufacturing for a Class III medical device. This role ensures that all product, process, and documentation requirements are successfully transferred, validated, and compliant with applicable FDA, PMA, and EU MDR requirements. The ideal candidate will have a strong background in medical device development, manufacturing readiness, and regulatory documentation, with a proven ability to manage complex, cross-functional programs in a fast-paced environment.

What You'll Do Design Transfer Execution

Own the design transfer plan and timeline from engineering to external manufacturing, ensuring alignment with PMA and EU MDR milestones.
Lead the finalization, review, and release of all documentation required by the design transfer plan.
Coordinate Engineering Change Orders (ECOs) and ensure traceability of design inputs and outputs with Contract Manufacturing Organizations (CMOs).

Manufacturing Readiness

Partner with CMOs to ensure process capability, equipment readiness, and production line qualification.
Coordinate and oversee the execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols with CMOs.
Ensure all manufacturing documentation, including work instructions, process flows, and control plans, is complete and audit-ready.

Regulatory & Quality Alignment

Collaborate with Regulatory Affairs to ensure all manufacturing-related sections of the PMA submission are complete, accurate, and supported by appropriate validation documentation.
Work with Quality Assurance to ensure supplier and CMO processes comply with ISO 13485, FDA 21 CFR Part 820 (QMSR), and applicable EU MDR requirements.
Support internal and external audits and regulatory inspections, including FDA inspections and Notified Body assessments.

Cross-Functional Program Management

Facilitate design transfer meetings with stakeholders across R&D, QA/RA, Supply Chain, and Manufacturing.
Track program deliverables, manage risks, and escalate issues to leadership with proposed mitigation plans.
Maintain program dashboards, KPIs, and documentation in accordance with the internal Quality Management System (QMS) and project governance requirements.

ERP and Data Integration

Ensure product and process data are accurately configured in the ERP system, including routings, part numbers, and revision control.
Coordinate with IT and Supply Chain teams to ensure ERP readiness for commercial production and distribution.

What We're Looking For Required Qualifications

Bachelor's degree in Engineering (Biomedical Engineering or Mechanical Engineering preferred). An advanced degree is a plus.
5–10 years of experience in medical device development, manufacturing, and/or design transfer, ideally involving Class III or PMA-regulated products.
Demonstrated experience leading cross-functional programs involving external manufacturing partners.

Preferred Qualifications

Strong knowledge of FDA QMSR, EU MDR, ISO 13485, and process validation (IQ/OQ/PQ).
Proficiency with ERP systems (e.g., SAP, Oracle, QAD) and document control tools.
Fluency in English; German language skills are a plus.

Physical Demands and Work Environment

Frequent use of a computer keyboard, monitor, and mouse; frequent sitting, standing, and walking; occasional lifting or moving of objects of varying weights.
Irvine, California-based. This is a fully onsite position, with occasional international travel to Stuttgart, Germany.

Compensation

The anticipated base salary range for this position is $110,000–$125,000 annually. Actual compensation will be determined based on experience, qualifications, skills, and location. Kardion offers a comprehensive benefits package, including medical, dental, and vision coverage, a 401(k) plan, and paid time off.

Equal Opportunity Statement Kardion is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic under applicable law.

Apply on kardion.applytojob.com About employer

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Jobs in the United States