Staff Manufacturing Engineer

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.