iota Biosciences
Healthcare
MechanicalEngineerII
Neural analysis suggests this role is
optimal for Mid candidates.
“Mechanical Engineer II at iota Biosciences. Support product development. Develop test infrastructure”
Industry & Context.
Root cause analysis
What They're Looking For.
Must Have
Bachelor's in Mechanical Engineering, 2+ years of industry experience, Familiarity with manufacturing processes, Experience with fixture design, Experience drafting test methods, Working knowledge of design controls, Proficiency with Microsoft Office, Written communication skills, Verbal communication skills, Ability to adapt
Nice to Have
Experience designing electro-mechanical test systems, Microcontroller integration experience, Experience in Medical Devices, Hands-on experience with CNC machining, Experience developing fixturing, Experience authoring IQ/OQ protocols, Experience working with contract manufacturers
What You'll Do.
Support product development
Develop test infrastructure
Author verification activities
Execute verification activities
Support manufacturing readiness
Create specifications
Create test documentation
Create engineering reports
Support root cause analysis
Support corrective actions
Partner with electrical teams
Partner with firmware teams
Partner with systems teams
Partner with quality teams
How You'll Work.
Team & Collaboration
Cross-functional partners; Electrical teams; Firmware teams; Systems teams; Quality teams
Communication Scope
Written communication; Verbal communication; Technical documentation
Full Job Description
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 documentati
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