Principal Engineer - Device/Combination Product Sterilization

Roche • South San Francisco, CA

63d • $109,500 - $203,300 • Onsite

About The Position

In this role, you will join a collaborative, cross-functional team dedicated to advancing life-saving healthcare solutions. You will serve as a technical expert in evaluating, validating, and optimizing sterilization processes for medical devices and combination products across the entire product lifecycle.

Requirements

• Bachelor's, Master's, or Ph.D. degree in Engineering, Science, or a related technical discipline, paired with at least 5 years of total professional experience (including 3+ years in medical devices, biotech, healthcare, or pharmaceuticals).
• Familiarity with international sterilization standards (such as ISO 11135, ISO 14937, or ISO 11137).
• Solid understanding of cGMP requirements, Good Documentation Practices (GDP), design verification/validation, and risk management tools (such as FMEA, ISO 14971); working knowledge of ISO 13485
• Strong written and verbal communication skills with a proven ability to partner effectively across cross-functional teams and external vendor networks.

Nice To Haves

• Practical experience with electron beam, ethylene oxide, or steam sterilization.
• Working knowledge of microbiological testing, biocompatibility and associated international standards(ISO11138, ISO14161, ISO10993) required to support sterilization process validation.
• Proven track record of working effectively in a matrix organization with a highly cross-functional (e.g., device development, regulatory, clinical, quality, and program management) and collaborative) environment is very desirable.

Responsibilities

• Lead Sterilization Strategy: Evaluate and select appropriate sterilization methods (including radiation, heat, and chemical methods) for new primary containers, medical devices and combination products.
• Drive Validation & Requalification: Develop, execute, and author protocols and technical reports for sterilization process validation (IQ, OQ, PQ) and equipment qualification in compliance with cGMP and international standards.
• Enhance Quality & Compliance: Perform root cause analyses on process issues, implement continuous improvements, and manage risk, discrepancy, and change documentation within design control frameworks. Support internal audits, regulatory inspections, and notified body interactions by preparing responses and driving the closure of corrective actions.
• Cross-Functional Collaboration: Partner closely with Commercial Marketing, Clinical Sciences, Quality, Regulatory Affairs, and Packaging and Pharmaceutical Development teams to seamlessly integrate sterilization guidance into device commercialization.
• External Partner Oversight: Oversee contract sterilizers and specialized testing laboratories to ensure project objectives and rigorous safety standards are met.
• Process & Method Innovation: Execute test-method validation projects using appropriate statistical tools, applying engineering and scientific principles to solve complex technical challenges.

Benefits

• Relocation benefits are available for this job posting.
• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree