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Job Summary:
We are looking for an experienced Electrical Engineer specializing in
development engineering for medical devices. This role focuses on the design
transfer process to manufacturing, as well as collaboration with suppliers and
manufacturing teams in process development and qualification. The ideal
candidate will have a robust understanding of electrical systems in medical
devices and a proven track record of successful product development.

Key Responsibilities:

* Lead the design transfer process for electrical components of medical
devices, ensuring a seamless transition from design to manufacturing.
* Collaborate with manufacturing engineers and production teams to optimize
electrical designs for manufacturability and scalability.
* Work closely with suppliers to develop, qualify, and implement
manufacturing processes for electrical components, including PCB assembly and
testing.
* Perform risk assessments and failure mode effects analysis (FMEA) to ensure
product safety and reliability throughout the manufacturing process.
* Conduct validation and qualification of electrical systems and processes,
including process validation and design verification/validation.
* Provide technical support and guidance during the manufacturing process,
addressing any engineering challenges that arise.
* Create and maintain comprehensive documentation for design transfer,
process validation, and compliance with regulatory requirements (e.g., ISO
13485, FDA).
* Engage in continuous improvement initiatives to optimize processes, reduce
costs, and enhance product quality.
Qualifications:

* Bachelor’s degree in Electrical Engineering or a related field; Master’s
degree preferred.
* Minimum of 8 years of experience in electrical engineering, with a focus on
medical device development and design transfer.
* Strong knowledge of electrical system design, circuit design, and PCB
layout specific to medical devices.
* Demonstrated experience with supplier management, process development, and
qualification in a manufacturing environment.
* Familiarity with industry regulations and standards applicable to medical
devices, including ISO 13485 and FDA/NMPA requirements.
* Excellent analytical and problem-solving skills, with a meticulous
attention to detail.
* Strong communication and collaboration skills to work effectively with
cross-functional teams.
Preferred Skills:

* Experience with systems integration and interdisciplinary collaboration
among engineering, manufacturing, and regulatory affairs.
* Proficiency in using design and simulation tools and quality management
systems.
* Knowledge of software development for embedded systems and the regulatory
implications of software in medical devices.