Mechanical Engineer II

iota Biosciences, Inc.•Alameda, CA

About The Position

iota Biosciences, a wholly owned subsidiary of Astellas Pharma US, is advancing a new class of bioelectronic medicines through the development of fully implantable Class III medical devices. Our proprietary technologies open therapeutic and diagnostic possibilities not previously accessible to clinicians. Together with Astellas, we are committed to patient-centric design, scientific and engineering excellence, and cross-functional teamwork. These principles guide us in bringing transformative, first-of-its-kind technologies into the clinic and closer to patients. Mechanical Engineer II The Mechanical and Manufacturing Engineering team is a group of highly skilled engineers solving complex challenges across the development lifecycle of implantable medical devices and supporting systems. As a Mechanical Engineer II, you will contribute hands-on technical expertise to the design, development, and verification of both implantable devices and external equipment. You will work closely with technical leads and cross-functional partners to execute on program goals, develop robust test methods, and support the transition from concept through production.

Requirements

Bachelor’s degree in Mechanical, Biomedical Engineering, or related field
2+ years of industry experience
Familiarity with manufacturing processes and production environments
Experience with fixture design for testing or manufacturing environments
Experience drafting and executing test methods, protocols, and reports
Working knowledge of design controls (FDA 21 CFR 820.30)
Proficiency with Microsoft Office (Excel, Word, PowerPoint)
Strong written and verbal communication skills
Ability to adapt in a fast-paced, evolving development environment

Nice To Haves

Experience designing electro-mechanical test systems with microcontroller integration (e.g., motorized systems, PLCs, Arduino-based controllers)
Experience in Medical Devices (Class II or III)
Hands-on experience with CNC machining and G-code
Experience developing fixturing for design verification and manufacturing
Experience authoring IQ/OQ protocols for equipment and fixtures
Experience working directly with contract manufacturers, including on-site support and process debugging

Responsibilities

Contribute to product development – support the design and development of implantable devices and external systems, from early concepts through verification and validation
Develop test infrastructure – design and build fixtures for design verification and manufacturing, including electro-mechanical test systems
Author and execute verification activities – develop test methods, protocols, and reports to support design verification and regulatory requirements
Build and test prototypes – assemble and evaluate prototype devices to inform design decisions and characterize performance
Support manufacturing readiness – assist in transitioning designs to production, including working with suppliers and contract manufacturers
Drive technical documentation – create specifications, test documentation, and engineering reports to support development and compliance
Investigate failures – support root cause analysis and corrective actions for device and process failures
Collaborate cross-functionally – partner with electrical, firmware, systems, and quality teams to deliver integrated solutions