Paramit is a rapidly growing international medical device contract design and manufacturing company that has been designing, and manufacturing high-quality medical and life sciences instruments. Located in Morgan Hill, CA, we offer a rewarding work environment with global opportunities while maintaining a small company, employee-focused, and highly collaborative culture. We are adding a Manufacturing Engineer to support NPI projects in an ISO 13485/FDA regulated space. Tecan, a global leader in lab automation solutions, has recently acquired Paramit and this opportunity will be a part of transitioning Tecan products into Paramit Manufacturing, along with supporting both groups with the ability to grow through this tremendous opportunity.
Essential Duties and Core Responsibilities:
- Ability to read and interpret assembly drawings, Bills of Material, and related engineering documentation.
- Understanding of printed circuit fabrication processes including solder paste printing, placement, reflow profiling of thermal characteristics, automated inspection parameters, and IPC 610 acceptability requirements
- Customer service knowledge and the ability to respond quickly to customer requests for information and data
- Knowledge of wave solder, BGA placement, rework, and hand soldering.
- Understanding of Engineering Change Orders and the extensive impact to all facets of production due to implementation of ECO activity
- Familiarity with databases, all MS Office applications and demonstrated proficiency with all s/w applications used for manufacturing
- Generating and presenting Design for Manufacturability reports to the customer
- Experience with using X-ray equipment for both inspection and failure analysis
- Understanding of FMEA and risk management
- Keen awareness of defect recognition/prevention and control
- Knowledge of statistical analysis tools: SPC, DOE, C/E diagrams
- Familiarity with Corrective and Preventive action
- Ability to create complex workflows and essential work instructions down to the operator-level
- Excellent written and verbal skills
Minimum Experience & Education Requirements:
- Four-year degree or equivalent work experience in an engineering capacity. Mechanical, Electrical, or Industrial Engineering.
- Experience with Contract Manufacturing Industry business practices
- Understanding and experience of complex PCBAs including FPGAs, multi-layer boards with analog and digital circuits, ability to read schematics, review PCB layout files and manage product quality
- Knowledgeable in compliance requirements, including product safety as it pertains to manufacturing
- Familiarity with ISO 13485, FDA QSR requirements, and product validation requirements for medical devices
Working with Paramit, you will be at the forefront of technology and a part of making a difference in the medical device and life science instrument industries. These industries touch an immeasurable amount of people, communities, countries, and our world.
At Paramit we are committed to excellence at every level in the organization. As a manufacturer and designer of highly complex, medical devices and life science instruments, we are acutely aware of our responsibility to those who will one day use the products we make. As a result, Paramit is obsessive about doing things the right way, going beyond FDA requirements, and ensuring that every finished product is safe and reliable.