Senior Packaging Engineer — Medical Device Lead & Validate

Terumo Neuro; Aliso Viejo (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Terumo Neuro is seeking a Staff Engineer, Packaging in California to lead complex packaging projects across development, production, and sustaining activities. You will craft specifications, validate sterile and non-sterile systems, and mentor cross-functional teams to ensure regulatory and quality compliance.

The role requires six years of packaging engineering experience in the medical device sector, CAD proficiency (SolidWorks), and strong communication skills to coordinate with Regulatory,

Qualifications

• Bachelor degree in packaging or related engineering field.
• Minimum six years of relevant work experience.
• Medical device experience required.
• Ability to lead cross-functional teams.
• Experience with packaging validations and design controls.
• Proficiency with CAD tools such as SolidWorks.

Responsibilities

• Lead packaging development, improvement, and transfer projects for medical devices.
• Support sterile and non-sterile packaging systems for new products and line changes.
• Develop and maintain packaging documentation including BOMs, test methods, and validation protocols.
• Contribute to design control deliverables (DFMEA/PFMEA) and change management.
• Draft and report packaging validations per ISO 11607 and FDA requirements.
• Collaborate with Manufacturing, Quality, Regulatory, R&D and Supply Chain to resolve issues.
• Perform packaging validations including integrity, transportation simulation, and aging studies.
• Define packaging strategies and validation plans for new product introductions.
• Analyze data and drive improvements to packaging processes.
• Evaluate packaging materials and supplier changes with internal teams.

Skills

Cross-functional leadership

Strong communication

Process validation

Technical writing

Education

Bachelor of Science in Packaging Engineering or related field

Tools

SolidWorks

Job description

Terumo Neuro is seeking a Staff Engineer, Packaging in California to lead complex packaging projects across development, production, and sustaining activities. You will craft specifications, validate sterile and non-sterile systems, and mentor cross-functional teams to ensure regulatory and quality compliance.

The role requires six years of packaging engineering experience in the medical device sector, CAD proficiency (SolidWorks), and strong communication skills to coordinate with Regulatory,