Job Title: Principal Engineer, THV Manufacturing
- Principal Engineer I, THV Manufacturing
- Principal Engineer II, THV Manufacturing
- Principal Engineer III, THV Manufacturing
Role Level: Individual Contributor
Supervisor/Manager Title: Senior Global Manager, Manufacturing Engineering
Job Location & Environment: Irvine, CA - Corporate Office
Job Description Summary: The Principal Engineer, THV Manufacturing will lead manufacturing engineering activities supporting a commercial Class III medical device manufacturing line, acting as a key interface across Operations, Quality, Regulatory, R&D and Supply Chain. This role is responsible for maintaining and improving released manufacturing processes to ensure product quality, compliance, and supply continuity. This position will drive standard cost reduction, yield improvement, and waste elimination, while strengthening process stability and day-to-day operational performance. In parallel, the Principal Engineer will play a key role in building and improving how manufacturing engineering operates, ensuring processes are consistent, scalable, and effective in a commercial production environment.
Job Responsibilities: - Analyze manufacturing KPIs and lead improvement efforts to drive cost reduction, yield improvement, and throughput gains in commercial production
- Identify, prioritize, and execute standard cost reduction opportunities across materials, labor, and process efficiency
- Lead structured problem solving (e.g., root cause analysis, CAPA) to reduce scrap, improve yield, and stabilize existing processes
- Serve as a primary engineering resource supporting day-to-day manufacturing operations, ensuring timely resolution of issues impacting quality or output
- Partner with Quality and Regulatory to ensure all activities are executed in compliance with Class III medical device requirements, maintaining validated state and audit readiness
- Lead and support process changes, re-validations, and engineering change controls, ensuring improvements are implemented with minimal disruption to production
- Drive lean manufacturing improvements (waste reduction, improved flow, standard work) to increase efficiency and reduce variability
- Provide technical leadership for sustaining engineering activities, ensuring processes are robust, repeatable, and continuously improving over time
- Support and lead equipment, tooling, and fixture design, development, and implementation, including hands-on CAD design (SolidWorks preferred)
- Evaluate and improve manufacturing equipment and tooling to ensure reliability, maintainability, and cost effectiveness in production
- Apply experience from more mature manufacturing environments to help evolve JenaValve processes, tools, and ways of working into a more structured and scalable system for commercial production
- Partner cross-functionally with Operations, Quality, R&D, and Supply Chain to resolve complex manufacturing issues and implement sustainable solutions
- Analyze and resolve manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations)
- Develop and maintain manufacturing documentation (e.g., work instructions, standard work, validation documents) to support consistent execution
- Lead and mentor engineers and technicians, providing clear technical direction and feedback
- Lead complex projects and initiatives, including planning, execution, implementation and process monitoring
- Lead complex projects and initiatives, including planning, execution, implementation, and process monitoring to ensure sustained improvements in performance, cost, and yield
Required Education and Experience: - Bachelor of Science degree in Mechanical, Biomedical, or related Engineering discipline is required.
- Minimum of 12+ years of experience in a medical device manufacturing environment, with strong experience (5+ years) supporting commercial production.
- Demonstrated experience supporting Class III medical devices or similarly regulated, high-risk products.
- Strong experience with process validation, equipment qualification, and change control within medical device regulated environments.
- Proven track record of delivering cost reduction, yield improvement, and efficiency gains in production environments.
- Medical device manufacturing engineering experience with porcine pericardial tissue heart valves (or similar Class III device) preferred.
- Six Sigma (Green Belt or Black Belt) and/or Lean Manufacturing certification preferred.
Skills and Abilities Required for This Job: - Strong technical leadership and ability to influence cross-functional teams
- Ability to operate effectively in a regulated, high-complexity manufacturing environment
- Hands-on, data-driven problem-solving skills with a focus on execution and results
- Strong understanding of GDP/GMP, FDA QSR, and/or ISO 13485 requirements
- Clear and effective communication skills with both technical and non-technical audiences
- Ability to manage multiple priorities with strong attention to detail
- Strong documentation and technical writing skills
- High level of ownership, accountability, and initiative
Physical Requirements: - Ability to perform duties in both office and manufacturing environments.
