Mechanical Engineer II

About Iota 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. What You’ll Do 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 What You’ll Bring 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 Preferred Qualifications 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 Why Join Us Mission with impact – see your work directly enable life‑changing therapies Cutting‑edge impact – work on a proprietary platform that’s redefining what’s possible Growth opportunities – shape not only the product but also the future of the company’s technology roadmap Benefits Health & Wellness Comprehensive health coverage for you and your family, covered at 100% Access to quality dental and vision coverage Onsite Gym in Alameda Work‑Life Balance Generous vacation pay Paid parental leave Options for flexible work schedules Competitive Compensation Annual Bonus Plan Long Term Incentive Plan (LTIP) 401(k) plan with employer match Compensation Range: $106K - $143K #J-18808-Ljbffr iota Biosciences, Inc. powered by Astellas