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.

Electrical Systems Engineer

iota Biosciences, Inc., a Berkeley-based medical device company is looking to hire a highly-motivated engineer with skills in embedded hardware, software, and system design.

Responsibilities

  • Contribute to system specifications and design of hardware systems.
  • Design and develop electrical hardware systems which include implantable components and new ultrasound technology
  • Prototype new hardware systems and work with cross-functional teams to perform system evaluation and testing.
  • Support manufacturing and process development teams to bring successful designs to production.
  • Contribute to design of analog/digital systems utilizing MCU and FPGA

Minimum Qualifications

  • B.S., M.S., or PhD in electrical engineering, computer science, or other related field.
  • Experience working with FPGAs and a hardware description language (VHDL or Verilog).
  • Experience with verification methodologies, RTL and gate level simulation and debug
  • Hands on experience with lab debug equipment, such as oscilloscopes and logic analyzer
  • Experience with microcontrollers, embedded development, and programming languages.
  • Fluent with C in embedded and standard computer architectures.
  • Experience in initial system bring-up, debugging, and test

Preferred Qualifications 

  • Experience with PCB design.
  • Experience analyzing root cause, design debugging, and problem solving with engineering test equipment
  • Experience in scripting languages, such as Python and MATLAB, for instrument automation and data analysis
  • Experience in or strong interest for working in medical devices or life sciences industry
  • Knowledge of ISO 13485 medical device regulations and FDA design controls

To apply, please email hiring@iota.bio

FPGA Designer

iota Biosciences, Inc., a Berkeley-based medical device start-up developing novel bioelectronic diagnostics and therapies, is looking to hire a highly motivated engineer to design, implement, optimize, and test FPGA modules for a medical device system.

Responsibilities:

  • Implement FPGA designs using Verilog and System Verilog.
  • Develop robust simulation models and self-checking test benches.
  • Design electronic subsystems including digital signal processing functions, control functions, and digital communications functions.
  • Design test and verification methods and capabilities for electronics and electrical systems.
  • Document FPGA requirements, specifications, test plans, and other supporting documentation
  • Collaborate with other engineering disciplines to design a system satisfying all requirements

Minimum Qualifications:

  • Bachelor of Science Degree or higher in Electrical or Computer Engineering.
  • 3+ years FPGA design using Verilog or System Verilog.
  • Experience with a scripting language such as python or MATLAB
  • Experience with signal processing, communications and control functions.

Preferred Qualifications:

  • Experience working in a startup environment.
  • Significant experience in medical device or other regulated industry.
  • Proficiency with C programming
  • Experience designing custom DSP algorithms optimized for a sensor-based application.
  • Knowledge of energy harvesting communication devices, like RFID

To apply, please email hiring@iota.bio

About Us:

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.

Job Summary

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

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.

Location

iota Biosciences is based in Alameda, California.

Minimum qualifications

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.

Preferred qualifications

· 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.

About Us:

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.

Responsibilities:

The Program Manager supports the high-quality and timely execution of the company projects. They will support the implementation of strategic decisions and product direction changes per the evolving project objectives. The Program Manager role will provide oversight over the scope, budget and schedule of the company projects as well as supporting resource allocation decisions. The responsibilities include leading projects as assigned. The Program Manager performs additional duties as directed.

  • Create detailed plans and timelines to deliver against set goals
  • Own and build the schedule and daily project management for several projects
  • Organize regular team meetings to drive progress and review action items
  • Maintain schedules and plans up-to-date through collaboration with cross-functional teams
  • Identify and communicate program risks and drive mitigation measures
  • Ensure Design Control processes are follower per relevant procedures and support document generation.
  • Support document generation in coordination with Quality and Regulatory functions
  • Serve as point of contact for communication on project status, critical path, and program risks

Qualifications:

  • 2-5 years minimum experience in program or project management, experience with project management tools
  • Bachelor’s degree in relevant technical field
  • Excellent organizational and communication skills, detail oriented
  • Ability to work with cross-functional teams and manage multiple projects at once
  • Familiarity with fast-paced environments and ability to manage ambiguity
  • Ability to influence and motivate all levels of an organization

Preferred Qualifications:

  • Bachelor’s degree in Life Sciences or relevant technical field. Master’s degree preferred
  • Experience in medical devices, pharmaceuticals, or other life sciences regulated industry
  • Experience in an ISO 13485 regulated environment
  • Experience with FDA Design Controls preferred

About Us:

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.

Senior Regulatory Affairs Specialist:

We are looking for a Sr. Regulatory Affairs Specialist who is highly motivated and passionate to create and implement innovative regulatory strategies for novel Class III active implantable devices, support the day-to-day regulatory activities, and collaborate with cross-functional teams. Additionally, the Sr. RAS will be expected to:

  • Provide regulatory support for new products/therapies
    • Develop regulatory strategies that align with business goals
    • Lead preparation of regulatory submissions for new products and product changes as required to ensure timely approvals
    • Negotiate submission issues with agency personnel
    • Lead cross-functional team efforts to resolve potential regulatory issues and questions from regulatory agencies
    • Establish and maintain good relationships with agency personnel
  • Maintain proficiency in worldwide regulatory requirements
    • Monitor and interpret changes to regulatory requirements
    • Assess impact to projects/processes and communicate this information to departments within the company that may be affected by these changes
  • Create, review and revise SOPs, and other company and departmental procedures to ensure compliance
  • Represent Regulatory Affairs on Material Review Board, CAPA Review Committee and Change Control Board
  • Participate in the planning, conduct, and reporting for external audits as requested
  • Take on miscellaneous projects as assigned

Qualifications and Experience:

  • Bachelor’s degree in Engineering, Life Sciences, or related medical/scientific field
  • Regulatory Affairs Certification (RAC) is a plus
  • 3-4 years of regulatory experience in medical device industry
  • Experience in writing/preparing submissions for medical devices (PMA, 510(k)), IDE)
  • Technically savvy; must be able to discuss and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues
  • Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations. Ability to compile data and summarize results
  • Organized, efficient, process-oriented; high attention to detail
  • Effective interpersonal/communication skills
  • Works well under pressure in a dynamic timeline-driven environment
  • Ability to effectively manage multiple projects and priorities

About Us:

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.

Senior Manager, Clinical Operations:

We are seeking a Senior Manager, Clinical Operations. The Senior Manager of Clinical Operations will, in partnership with senior management at iota and Astellas, implement and manage early feasibility medical device clinical studies to achieve the project and corporate objectives. This position will work with cross-functional team members, clinical research organizations, and consultants to ensure the successful, cost-effective, and timely execution of clinical studies.

The successful candidate must be able to perform each of the following satisfactorily

  • Function as the study lead in managing the clinical operations team and cross-functional clinical trial team in the planning, execution and reporting of clinical trials
  • Manage external resources such as consultants, contractors, CRO’s
  • Responsible for managing study budgets including forecast and invoice approvals
  • Coordinate vendor meetings and review vendor documents (e.g., manuals, Master Service Agreements, contracts) for adequacy.
  • Develop project plans and schedule to include timelines, budgets and milestones.
  • Prepare and/or support preparation of clinical documents (e.g., protocols, study reference manuals, documents to be submitted to Regulatory agencies or ethics boards), Standard Operating Procedures and guidelines
  • Identify and assist in departmental training requirements including internal and external operations
  • Ensure all clinical activities are delivered in accordance with trial protocol, ICH/GCP guidelines and applicable SOPs and regulations
  • Supervise direct reports and matrixed study team
  • Understand the legal and compliance environment

Qualifications and Experience:

  • Bachelor’s or RN degree with a minimum of 5 years of experience in medical device industry. Advanced degree is a plus.
  • Minimum 5 years of experience in Clinical Operations roles with minimum 2 years as a study manager or study lead at a medical device company with a keen understanding of all aspects of Clinical Operations, including clinical trial design, study implementation/ start-up activities, site management, data management. Direct involvement in early phase human clinical trials highly preferred.
  • Knowledge of GCP, ICH guidelines and FDA regulations
  • In-depth experience soliciting CRO and key vendor proposals, critically evaluating competing proposals, negotiating key terms, and selecting/initiating these relationships
  • In-depth experience with early device development
  • Experience in reviewing or writing of clinical protocols, study manuals, case report forms, and informed consent forms
  • Understanding of the principles of project management and proven ability to lead a project team
  • Able to work in a fast-paced environment, well organized and self-directed
  • Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
  • Adaptable and able to work in a work environment where priorities are constantly changing
  • Ability to travel (Average travel expectations approximately 35%)

About Us:

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.

Senior Quality Engineer

We are looking for a Sr. Quality Engineer who is highly motivated and passionate to engage as a quality core team member on collaborative, quality focused design and development of novel Class III active implantable devices. The Sr. Quality Engineer will be expected to:

  • Provide quality focused design and development by engaging with cross-functional teams to define requirements, design, verification and validation plan and strategies
  • Review and approve design input/design output artifacts including requirements, design documents, code reviews, verification and validation results
  • Lead and conduct risk management activities including hazard analysis and FMEAs
  • Develop, modify, apply and maintain SOPs and other processes and procedures to ensure compliance to requirements and guidance
  • Lead and drive CAPA (Corrective and Preventative Action) projects as required.
  • Drive quality improvement projects to include compliance to new or updated requirements or guidance
  • Ensures that activities are complaint with policies and procedures

Qualifications:

  • Bachelor’s degree in Engineering or related field
  • Minimum 4 years of experience in a Quality function in a Medical Device company
  • Technically savvy; must be able to understand and review design artifacts regarding an array of engineering disciplines and technical issues.
  • Organized, self-motivated, ability to effectively manage multiple projects and priorities; high attention to detail
  • Effective interpersonal/communication skills

About Us:

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.

Document Control Coordinator

We are looking for a Document Control Coordinator who is highly motivated and passionate to manage quality system and product supporting documentation for novel Class III active implantable devices. The Document Control Coordinator will be expected to:

  • Lead implementation and continuous improvement activities for eQMS (Electronic Quality Management System)
  • Identify, process and release change orders for quality system and product documentation
  • Timely release and distribution of latest revision level documentation as required
  • Implement and ensure employee training on documents, SOPs and procedures
  • Responsible for accuracy of all controlled documents
  • Ensures document control activities are performed in accordance with SOPs and procedures

Qualifications:

  • Bachelor’s degree in Engineering or related field
  • Minimum 4 years of experience in a Quality function in a Medical Device company
  • Technically savvy; must be able to understand and review design artifacts regarding an array of engineering disciplines and technical issues.
  • Organized, self-motivated, ability to effectively manage multiple projects and priorities; high attention to detail
  • Effective interpersonal/communication

The ideal candidate is a generalist and can contribute to the entire stack of embedded hardware development, all the way from board bring-up to software development to user interaction.

Responsibilities:

  • Optimize an ultrasound control system implemented on an embedded platform containing a microcontroller and FPGA. Use modern software techniques to support multiple products while maximizing software reuse.
  • Collaborate with cloud engineers to develop the “big data” infrastructure for efficiently sending all required data from the embedded processor to the cloud backend, as well as retrieving any configuration data and messages from the backend.
  • Own the process of validating embedded software to medical regulatory standards while maintaining an industry-leading development pace.

Minimum qualifications:

  • Education: BS in computer science, electrical engineering, or related technical field.
  • 2+ years industry work experience programming in C on an embedded target. Demonstrated experience in shipping a product to market.
  • Articulate, motivated, independent, efficient and able to handle several projects in parallel. Interested in working in a small team environment with engineers of different skill sets.
  • In-depth experience in one or more of the following areas: real-time OS for embedded platforms, FPGA programming in Verilog/VHDL, implementation of data transfer protocols (SPI, I2C, UART, USB etc), PCB design for embedded systems, Interfacing with, and testing the interface of, peripheral devices connected to an embedded processor, Handling IoT data streams going to and from a cloud backend.
  • Experience with test automation tools (e.g., Jenkins) and modern software test/deployment methodologies.

Preferred qualifications:

  • Education: MS in computer science, electrical engineering, or related technical field.
  • Substantial prior experience with ISO 13485 (QMS), ISO 14971 (risk management) and/or IEC 62304 (medical device software)
  • Prior experience working with other engineers of different disciplines as well as product managers and designers.
  • Knowledge of energy harvesting communication devices, like RFID
  • Experience working with ultrasound systems is a plus.
  • Experience with oscilloscopes, FPGAs, microcontrollers and signal generators.
  • Experience in an HDL, such as Verilog or VHDL, is a plus.

Our Mission

iota Biosciences is dedicated to transforming how doctors monitor and treat disease by advancing our understanding of how bioelectronics can interact with the human nervous system. Building on award-winning “neural dust” technology developed by researchers at the University of California, Berkeley, iota is building a platform for the future of bioelectronic medicine.

Discover The Future

Contact Us