iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company pioneering bioelectronic solutions across a range of medical therapies and diagnostics. Bioelectronic medical implants are the start of an entirely new form of medicine, treating chronic diseases through non-pharmaceutical mechanisms not previously accessible to clinicians.
iota Biosciences, Inc. was acquired by Astellas Pharma US in November 2020. Astellas Pharma US, Inc. is an affiliate of Tokyo-based Astellas Pharma Inc., a top 20 global pharmaceutical research company. Astellas is committed to turning innovative science into medical solutions that bring value and hope to patients and their families. iota’s core proprietary technology stack leverages ultrasonic energy to communicate with and power custom implantable devices, enabling completely new clinical approaches to treating diseases. At iota Biosciences you will be given the opportunity to substantially influence the design and success of these pioneering Class III medical implants, as the company expands the reach of its novel technology while bringing new solutions to the clinic.
As a Sr. Manufacturing Design Engineer, you will own the manufacturing design and execution of our implantable and external products, including: working closely with our hardware engineering teams and CM’s to define appropriate specifications; designing, engineering and validation of fixtures; designing and validating robust processes for both component and system-level tests.
At iota Biosciences you will play a key role in taking company’s implantable devices from an early engineering prototype all the way to production.
Responsibilities may include the following and other duties may be assigned:
· Designs manufacturing processes, procedures and production layouts for parts and assemblies.
· Incorporates inspection and test requirements into the production plan.
· Designs electrical test fixtures for engineering and manufacturing uses.
· Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
· Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
· Ensures processes and procedures are in compliance with regulations.
iota Biosciences is based in Alameda, California.
Please ensure the minimum requirements are evident on your resume.
· Bachelor’s degree in Mechanical, Manufacturing, Industrial or Materials Science Engineering preferred.
· 4+ years of experience in a manufacturing role.
· Proficiency with CAD software (e.g. SolidWorks, Pro-Engineer).
· Experience with the design, assembly and test of electro-mechanical assemblies
· Demonstrated understanding of manufacturing processes (i.e. injection molding, machining, stamping, laser welding, ultrasonic welding)
· Experience in process characterization and validation using statistical tools such as SPC, GR&R, Cp/Cpk, Design of Experiments.
· Experience in ISO 13485 medical device manufacturing or similar regulated industry.
· Strong desire to be hands on and support a wide variety of activities.
· Portfolio of complex engineering challenges with high degree of ownership.
· Experience working with electrical and systems engineers to design automated PCBA Test Fixtures.