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Senior/Principal Electrical Engineer
Fremont, CA, USA
New employees are eligible for the following benefits effective date of hire!
Supports assigned customers to assure best in class design and quality for product and provides seamless communication between customers.
ESSENTIAL DUTIES AND RESPONSIBILITIES
·Design and develop class II and III implantable devices.
·Define new product system architecture such as sensor inputs, motor controller, communication interfaces, computer control and user interface.
·Develop requirements and specifications for electrical components, electrical sub-systems, and PCBs.
·Perform electrical design from concept, prototype to final product. Implement circuit design and oversee board layout for system circuit boards.
·Develop computer system and microcontroller design requirements. Implement test and bring-up strategies for new electrical and microcontroller components.
·Support validation and verification activities such as creating and executing protocols as well as documentation. Conduct board and system level verification and validation testing.
·Perform design control functions such as updating the Design History Files, generate specifications, test protocols and reports. Conduct design review and risk management assessments.
·Provide EE support for product design transfer to manufacturing including prototype and test fixture building, failure and root cause analysis of electrical sub-systems and components.
·Develop automatic system and module testing protocols to support manufacturing and production activities.
·Ensure compliance with all relevant EMC and electrical safety standards such as IEC-60601 and RoHS
·Ensure designs meet performance specifications, regulatory and manufacturing requirements.
·Interact with customers in a professional manner. Proactively communicate with customers to ensure an ongoing two-way exchange of information. Promptly respond to product issues, taking appropriate action within the Quality System and continually building strong rapport with customers and suppliers. Lead customer specific team meetings.
·Evaluate prototype devices.
·Prepare documentation release packages, including detail drawings, bills of material, and/or procedures. Approve Document Change Orders (DCOs) and obtain approvals from others as required.
·Working with all internal groups, identify trends and process gaps and suggest and assist in the implementation of corrective actions and process improvements.
·Collaborate with all departments to develop optimal work order routings and Device History Records.
·Perform other activities as directed.
SUPERVISORY RESPONSIBILITY
Possible supervision of 2-5 employees and external contractors.
REQUIRED EDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE
·Bachelor's degree in Engineering is desired, Masters preferred.
·Minimum 7 years of medical device product design and development experience is required, bioelectronic experience desired.
·Demonstrated ability to bring products from concept to market.
·Ability to interact with client companies in a professional manner.
·Familiarity with FDA, QSR, and ISO 13485 medical device regulations and standards.
·Depth of knowledge in neural stimulation or cardiac rhythm management.
·Depth of knowledge in one or more technical areas.
·Flexibility, persistence, passion, resourcefulness, a drive to succeed, and an entrepreneurial spirit.
PAY RANGE
We offer market competitive compensation. Potential salary range for this role is $140,000-$175,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
- Medical, dental, and vision benefits
- Company-paid life insurance and disability benefits
- Self-managed (unlimited!) PTO and 11 paid holidays
- 401k Plan with Company Match
- Tuition Reimbursement
Supports assigned customers to assure best in class design and quality for product and provides seamless communication between customers.
ESSENTIAL DUTIES AND RESPONSIBILITIES
·Design and develop class II and III implantable devices.
·Define new product system architecture such as sensor inputs, motor controller, communication interfaces, computer control and user interface.
·Develop requirements and specifications for electrical components, electrical sub-systems, and PCBs.
·Perform electrical design from concept, prototype to final product. Implement circuit design and oversee board layout for system circuit boards.
·Develop computer system and microcontroller design requirements. Implement test and bring-up strategies for new electrical and microcontroller components.
·Support validation and verification activities such as creating and executing protocols as well as documentation. Conduct board and system level verification and validation testing.
·Perform design control functions such as updating the Design History Files, generate specifications, test protocols and reports. Conduct design review and risk management assessments.
·Provide EE support for product design transfer to manufacturing including prototype and test fixture building, failure and root cause analysis of electrical sub-systems and components.
·Develop automatic system and module testing protocols to support manufacturing and production activities.
·Ensure compliance with all relevant EMC and electrical safety standards such as IEC-60601 and RoHS
·Ensure designs meet performance specifications, regulatory and manufacturing requirements.
·Interact with customers in a professional manner. Proactively communicate with customers to ensure an ongoing two-way exchange of information. Promptly respond to product issues, taking appropriate action within the Quality System and continually building strong rapport with customers and suppliers. Lead customer specific team meetings.
·Evaluate prototype devices.
·Prepare documentation release packages, including detail drawings, bills of material, and/or procedures. Approve Document Change Orders (DCOs) and obtain approvals from others as required.
·Working with all internal groups, identify trends and process gaps and suggest and assist in the implementation of corrective actions and process improvements.
·Collaborate with all departments to develop optimal work order routings and Device History Records.
·Perform other activities as directed.
SUPERVISORY RESPONSIBILITY
Possible supervision of 2-5 employees and external contractors.
REQUIRED EDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE
·Bachelor's degree in Engineering is desired, Masters preferred.
·Minimum 7 years of medical device product design and development experience is required, bioelectronic experience desired.
·Demonstrated ability to bring products from concept to market.
·Ability to interact with client companies in a professional manner.
·Familiarity with FDA, QSR, and ISO 13485 medical device regulations and standards.
·Depth of knowledge in neural stimulation or cardiac rhythm management.
·Depth of knowledge in one or more technical areas.
·Flexibility, persistence, passion, resourcefulness, a drive to succeed, and an entrepreneurial spirit.
PAY RANGE
We offer market competitive compensation. Potential salary range for this role is $140,000-$175,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
