Manufacturing Engineer II
Manufacturing Engineer II
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at [Register to View] style="color: #d91e49; text-decoration: none; text-underline: none;">www.astellas.com.
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 Manufacturing Engineer II, you will own the manufacturing design and execution of our implantable and external products, including: working closely with our 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:
- Work with suppliers and contract manufacturers to ensure components are manufactured to the required specifications
- Develop manufacturing processes, procedures and fixtures for the assembly of medical devices
- Generate and modify manufacturing process documentation such as work instructions, process parameter sheets, BOMs, FMEAs, DMR, and DHF documents, etc., maintained as per medical regulatory standards.
- Develop and validate test methods to ensure product quality
- Designs 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.
- Participate in design reviews and provide feedback on manufacturing feasibility
- Dispositions non-conforming products and develops required re-work procedures
- Ensures processes and procedures are in compliance with regulations.
iota Biosciences is based in Alameda, California.
- Up to 20% travel may be required.