Senior Electronics Engineer
PTS Advance Saratoga, CA
- Expired: over a month ago. Applications are no longer accepted.
Sr. Electronics Engineer II
• Bachelor’s degree in Engineering or related discipline or equivalent experience in the medical device industry.
• 10+ years previous experience including internships and coop positions; experience in the medical device industry preferred.
• Demonstrated experience in implementing technical strategy for a medical device project and coordinate with applicable cross-functional leaders to gain alignment.
• Experience with contributing to strategies for product design and development based on customer needs and Design Input. Demonstrated design and comparative analysis skills.
• Experience with performing comparative analyses on alternate product designs, component sources, process methods, or test methods and make a recommendation.
• Experience in presenting and explaining to upper/executive management.
• Previous Project Management experience a plus.
• Ability to design electric circuits in the development of medical devices
• Ability to lead the design and development of a new medical device on a bench top or pilot line scale from an Electronics perspective.
• Demonstrated successful execution of product design, development, and documentation.
• Experience with Design Control procedures and requirements
• Ability to create detailed Technical Reports appropriate to send to the FDA. Ability to create and train to SOP’s.
• Ability to appropriately document new or modified product designs to be contained in DHF’s or regulatory filings, or in-house engineering.
• Ability to create a material specification for any component procured from an outside source.
• Ability to define, write and perform DOE’s and test protocols for evaluating prototype performance to design criteria.
• Skilled in the use of design tool such as Eagle, OrCAD, Altium
• Experience working under quality systems designed to meet governmental regulations such as IEC 60601-1, IEC 62304, FDA QSR, and ISO 13485.
• Experience in design transfer from design phase to production phase.
• Experience outsourcing a Contract Manufacturer for the Electro- Mechanical medical devices.
• Ability to travel to observe clinical cases, attend trade shows, attend training activities, and visit suppliers, etc. will be required periodically.
• Demonstrated strong technical writing, validation, SOP, and presentation skills. (written communication)
• Experience in working for the Electro-Mechanical medical devices, which includes motors preferred.
• Experience in designing biological signal sensing technology preferred.
• Experience in designing digital circuits using FPGA or CPLD preferred.
• Experience in designing PCB checker for design transfer such as In-circuit tester.
• Knowledge of anatomy & physiology, clinical use of medical products preferred.
This position is responsible for design, development and technical problem solving of specific product/s in accordance the Quality System and customer requirements. This position is responsible for providing technical expertise, leadership, and planning to a large or several smaller technical projects. The Senior Electronics Engineer may serve as technical team leader and coach to other engineers. This position will ensure that assigned projects product/s are designed to facilitate manufacturability and will be responsible for technology transfer to manufacturing from an Electronics perspective. Participates in and/or conduct animal and bench top study projects.
1. Project Engineering: Provide engineering leadership in the design, development, and qualification of products and processes from an Electronics perspective. As part of a project team, or on an individual basis
a. Design electric circuits of the medical device
b. Design and define product testing plans and protocols. Perform testing, analyze results, suggest recommendations and/or conclusions and document clearly and completely in technical reports. These reports could be to support product development prototype evaluations, or could be submitted to the FDA to support new product clearance or claims
c. Research and recommend vendor and material choices for product.
d. Implement product performance and design strategies.
e. Prepare & lead technical design reviews to a cross-functional and technical team.
f. Contribute to the DHF and regulatory submittals providing training to ensure proper design transfer.
g. Ensure that product documentation is in accordance with Quality System requirements design control, quality, and company regulations and national and international regulatory body requirements. This activity includes, but is not limited to, the understanding of change control, validation, documentation practices, process control and design control requirements.
2. Project Management: Coordinate multi-functional project team activities from early project conceptualization through clinical testing and regulatory submissions.
a. Maintain and manage activities towards the overall project schedule, and ensure that critical timelines and/or budgets are established and met.
b. Projects & tasks to be completed include organizing and leading members of the project team, planning and scheduling technical activities, coordinating technical resources (personnel, materials, time, suppliers), and preparing proper documentation.
c. Perform as a Technical Lead on a project to lead and implement the technical aspects involving coordination with other departments.
d. Develop positive proactive working relationships with team members and other staff.
3. Regulatory Compliance: Provide engineering testing and documentation that is in accordance with regulatory requirements for approvals of products by the U.S. and foreign regulatory agencies. Support regulatory submissions by collaborating with regulatory affairs representative and providing technical support and response to the agencies.
4. Manufacturability: Ensure that new products or product enhancements are designed to facilitate manufacturability (DFM). May be required to lead or contribute to the process of transferring product from development to manufacturing.
5. Supervision: May be required to supervise, lead or train Engineers, in the project group.
6. Responsibilities to the Quality System:
a. Support the Quality System and Quality Policy.
b. Be aware of Quality System procedures and requirements, including regulatory requirements and training requirements for position activities.
c. Ensure staff are trained in applicable procedures prior to performing Quality related activities.
d. Inform responsible personnel of concerns involving product quality.
7. Intellectual Property: Ensure technical activities are properly documented in lab notebook. Participate in and contribute to technical discussion sessions to generate new intellectual property.
8. Safety: Perform job functions in a safe and effective manner. Ensure that employees under position supervision are adhering to the safety procedures of the company.
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