Manufacturing Electrical Engineer
Irvine, CA
Manufacturing – Operations Engineering /
Permanent - Full Time /
On-site
Planet Innovation (PI) is a globally recognised Healthtech Innovation and Manufacturing company. PI offers the full spectrum of product design, engineering and manufacturing services for its customers in the diagnostics, life sciences and healthcare industries. Our clients include many of the world's top medical device companies, as well as some of the world's most exciting medtech start-ups.
With HQ in Australia and the majority of its customers in the US, PI established a world-class manufacturing facility in Irvine, California in 2021 and this division is growing rapidly on the back of high demand for our production services by both existing and new clients.
PI has an authentic, transparent, supportive culture and we offer a broad array of comprehensive benefit programs for our employees, including medical, dental, vision, 401k with employer match, and paid vacation, holidays, and sick leave.
We are looking for a Manufacturing Electrical Engineer to join the Engineering team with demonstrated experience working in the medical device industry.
The Role
- Reporting to the Vice President, Engineering as a Manufacturing Electrical Engineer, you are responsible for manufacturing support and new product introduction (NPI) project deliverables providing input to critical decisions on design change, EOL assessment, electrical and electronic testing, troubleshooting and all compliance elements of a product, including EMC and Safety.
- This is an onsite position.
The Accountabilities
- Electrical and electronic troubleshooting and testing of prototypes, pilot builds, production builds, test equipment, fixtures, etc.,
- Maintenance of documentation including updates to schematics, layouts, assembly drawings, fabrication drawings and bill of materials.
- Ownership of change management and risk management activities of existing designs.
- Working as part of a project team, and on an individual basis to identify opportunities for improvements to existing specifications, to maximise product yield and cost effectiveness.
- Performing and writing technical assessments for EOL components
- Writing and performing verification and validation test protocols and reports.
- Training assembly technicians where appropriate.
- Applying design for manufacture, test and regulatory compliance to instrument manufacturing.
- Working with subcontractors where applicable e.g. build technicians, board layouts.
- Ensuring all product documentation is in accordance with Quality System requirements.
- Perform other duties as assigned.
The Typical Experiences
- A degree in electrical and/or electronic engineering
- A minimum of 3 - 5 years’ experience in an electrical/electronics role within the medical device industry.
- Experience working on in vitro diagnostic medical devices in a development and manufacturing environment.
- Ability to use Mechanical CAD tools (Solidworks).
- Ability to read and interpret electronic schematics and mechanical drawings.
- Experience troubleshooting and documenting evaluations of finished devices, sub-assemblies, component failures and equivalence assessments.
- Experience in using MS Office Suite.
- Understanding first principles, theories, and concepts relevant to electrical and electronics engineering.
- Experience working with suppliers (CMO; Contract Manufacturing Operations) of electronics components, subassemblies, and finished devices.
- Ability to manage competing priorities in a fast-paced environment.
- Must be able to work in a team environment, including inter-departmental teams and key contacts representing the organization on contracts or projects.
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
- Understanding of product and process change control, design control, MRP / Inventory processes, and Quality System requirements.
- Ability to perform root cause and failure analysis.
- Experience with Altium for review of design for manufacturing, testing, and troubleshooting.
- Familiarity with international quality standards e.g., ISO 9001, ISO 13485 and FDA QSR regulations.
- Customer facing experience in a consulting style environment.
$100,000 - $110,000 a year
We offer our team a broad array of comprehensive benefit programs for our employees, including medical, dental, vision, 401k with employer match, and paid vacation, holidays, and sick leave.
Full time employees and dependents are provided with medical coverage, and the company covers 100% of the premium cost.
To Apply
A positive, high-achieving work culture, and plenty of opportunities to learn and grow await you at Planet Innovation, so apply now.
We are proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees, and all suitably qualified applicants will receive consideration for employment without regard for race, gender, sexual orientation, religion, disability, or age.
Please note only applications with the right to live and work in the US will be considered for these positions.
No recruitment agencies, please.
