ELECTRICAL SYSTEMS ENGINEER (SENIOR / STAFF)

Job Summary Support development of novel electrical aerosol drug delivery device and other drug delivery systems, help establish and manage device design history file (DHF) and technical file; ensure contents are adequate to support regulatory submissions.
Support interdepartmental activities with respect to device design development, prototyping, assembling, design verification/validation, stability testing, design cycle and verification testing, specification development, investigations, testing to regulatory standards, etc.
Responsibilities Support design development and documentation of test analog and digital electronics for drug delivery devices Conduct in-house prototyping and testing of new device designs, test fixtures, cabling, generate test protocols and analyze/document test results in laboratory notebooks, write test reports and maintain engineering records to GMP standards Coordinate and work with certified test laboratories to perform testing of device to electrical safety and EMC standards such as IEC Prepare technical engineering documentation including specifications, hardware design description, electrical schematics, risk analyses, engineering drawings, specification control drawings, block diagrams, electrical design documents, etc.
Manage engineering lab (organize storage, maintain supplies, ensure users keep lab orderly and adhere to safety practices) Maintain engineering equipment.
Ensure measurement equipment in engineering lab is in calibration and update status in BMRAM (or replacement system when implemented).
Support QC in calibration of some equipment (Human Breath Profile Simulator (HBPS)) Interact with suppliers/vendors to help design/select components for product devices Contribute to intellectual property evaluations Participate in multiple project teams   Skills required Experience with hands-on electronics (soldering, testing, etc.) in the medical device or other regulated industry Analog and digital circuit design and analysis Experience with test fixture design using LabVIEW and other tools Excellent oral and written communication skills as well as strong interpersonal skills Well versed in Food and Drug Administration (FDA) regulations for medical devices and products, especially as it relates to building and maintaining a DHF and technical file Experience working in compliance with GMP regulations   Education and experience BSEE or higher or an equivalent foreign degree in Electrical Engineering or similar 6-10 years of experience in hardware, design, electrical, or electronics engineering related to the development of medical devices; aerosol drug delivery device experience is a plus   Physical Requirements Prolonged periods of sitting at a desk and working on a computer Potentially prolonged periods standing Must be able to lift up to 15 pounds at times Must be willing to travel The annual base salary for this role starts at $.
Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training.
Our compensation package also includes diverse health benefits, an LTI plan, and an annual target bonus for full-time positions.
Who We Are At Ferrer we are a group of people who believe in the power of purpose.
And our purpose is to make a positive impact in society and bring about change in an unjust world.
We are the 24/7 activists fighting for a sustainable planet, equal opportunities for all and a healthy workplace.
We reject greenwashing and empty promises - we are about action.
That is why in we became a B Corp company.
Alexza Pharmaceuticals is part of Ferrer and is an R&D and Manufacturing center located in Fremont, CA.
Our focus is to develop technologically advanced, forward-thinking and innovative products for our pipeline based on the Staccato One Breath Technology.
We research, develop and manufacture novel, proprietary products for the acute treatment of underserved medical needs.
Why Alexza/Ferrer Make a positive impact in society Participate in volunteering activities Grow in a culture of trust, responsibility, and constructive feedback Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking Make a real difference to the team and to yourself Take advantage of opportunities for development & learning Discover a range of benefits to support your physical, emotional and financial wellbeing Requirements What you’ll need to succeed  We believe that a combination of benefits and unique career development programs allows our dedicated professionals to thrive in a culture where collaboration and creative thinking are the order of the day.
You will rock at our company if you are a person that connects with our values.
empathy, humility, curiosity and optimism in addition to the following qualities.
You are a purpose and value driven person Embrace cultural change Have entrepreneurial spirit Have outstanding people skills Have excellent communication skills If you’re looking for diverse challenges, then we are waiting for you! Alexza/Ferrer is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.
.
Armed Forces or any other characteristic protected by applicable federal, state, or local laws.