Manager, Failure Investigation Engineering - Pleasanton, CA

Calyxo•Pleasanton, CA

8d•$150,000 - $170,000•Onsite

About The Position

The Manager, Failure Investigation Engineering leads the team responsible for investigating, analyzing, and resolving product complaints and adverse events. The role ensures timely, compliant complaint handling, identifies trends, and drives continuous improvement. It works cross-functionally with Medical Affairs, Regulatory, Operations, R&D, Customer Service, Quality Engineering, Manufacturing, Product Development, Clinical, Field Service, Engineering, and QA to support post-market surveillance and maintain product safety and quality. The manager leads, mentors, and develops investigators, engineers, and technicians; oversees daily complaint investigation operations; manages the investigations lab and its tools and equipment; and reviews and approves investigation outcomes and reports. The role conducts and supports product testing, troubleshooting, root-cause analysis, risk evaluation, lot history reviews, complaint trend analysis, CAPA investigations, internal audits, and compliance reporting. It also serves as the subject matter expert for product investigations during audits and maintains technical documentation in accordance with applicable regulations and standards, including FDA requirements, ISO 13485, and EU MDR. The position is based in Pleasanton, California, with travel of up to 10%. It reports to the Sr. Manager, Product Monitoring. The posting describes a collaborative, diverse, and inclusive work environment and offers a competitive base salary of $150,000–$170,000, a variable incentive plan, stock options, 401(k), healthcare insurance, and paid vacation.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related technical field, or equivalent practical experience.
At least 8 years of experience in the medical device industry, focused on post-market surveillance, complaint handling, or quality investigations.
Strong working knowledge of applicable medical device regulations and global quality management systems, including FDA requirements, ISO 13485, and EU MDR.
Demonstrated experience managing Class II or III medical devices.
Proven leadership skills and a track record of developing high-performing teams.
Excellent analytical, problem-solving, and technical writing skills.
Proficiency in data analysis tools and methodologies for complaint trending.
Strong verbal and written communication skills, including the ability to present findings to technical and non-technical audiences.
Strong attention to detail and organizational ability to manage multiple priorities and projects.
Ability to work in a cross-functional, fast-paced environment with minimal supervision.
Open and direct communication style and commitment to continuous improvement and operational excellence.
Ability to lift 10 pounds and occasionally lift and carry up to 25 pounds, sit for up to 4 hours per day, perform daily keyboard data entry, and stand while working on device investigations.
Compliance with relevant county, state, and federal vaccination and health requirements.
Legal authorization to work in the United States.

Nice To Haves

Experience with sterile and/or electronic medical devices.

Responsibilities

Lead, mentor, and develop a team of investigators, engineers, and technicians, including recruiting, onboarding, training, and performance management.
Set and manage individual and team goals aligned with departmental objectives.
Oversee day-to-day complaint investigations to ensure timely closure and regulatory compliance.
Ensure investigation documentation, procedures, and laboratory records are accurate, complete, and current.
Train team members on complaint investigation techniques, product-specific evaluations, and regulatory requirements.
Recommend and implement improvements to investigation procedures and processes.
Manage the investigations laboratory and ensure appropriate tools, test equipment, and resources are available and functional.
Review and approve investigation outcomes and reports for accuracy, completeness, and clarity.
Serve as the subject matter expert for product investigations during internal and external audits.
Participate in and contribute data to the monthly Complaints Review Meeting.
Test and troubleshoot returned products to determine failure root causes.
Collaborate with Quality Engineering, Manufacturing, and Product Development to verify root causes and connect them to customer-reported issues.
Escalate new or critical failure modes and partner with Field Service, Engineering, and QA on resolution.
Work with Clinical, Regulatory, and Medical Affairs to evaluate hazards and patient risk during investigations.
Perform Lot History Reviews as needed.
Identify and communicate emerging trends based on complaint data analysis.
Support Quality System activities, including CAPA investigations, internal audits, and compliance reporting.
Maintain technical documentation in compliance with FDA regulations, ISO 13485, EU MDR, PAL, and other applicable standards.
Contribute to a collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun workplace culture.