Electrical Systems Manufacturing Specialist
hace 1 día
Horizons is seeking a skilled Electrical Systems Manufacturing Specialist to join our team in Oradea, Romania. This pivotal role involves site-based manufacturing activities related to the implementation, qualification, and sustaining of electro-mechanical products. As an expert in electrical components, you will be responsible for managing new product implementations, production ramp-ups, and problem-solving in a regulated environment.
About the Job:
- This is a permanent, full-time position with a hybrid work arrangement, requiring presence at both the home office and manufacturing site.
- The ideal candidate will have 2+ years of experience in post-release design or engineering support of medium-volume electro-mechanical products, preferably in a regulated industry like medical devices.
- You should be proficient in assembly and manufacturing processes, particularly in electrical/electronics assembly, and familiar with IPC standards and quality control techniques.
- A strong understanding of validation processes (TMV, IQ, OQ, PQ) and quality systems (cGMP, CFR820, ISO13485) is also essential.
- In addition to technical expertise, excellent communication skills, both verbal and written, are necessary to collaborate with various teams and ensure compliant execution of quality systems and processes.
Responsibilities:
- Process Implementation: Collaborate with contract manufacturers to implement robust manufacturing processes that meet product specifications and performance criteria within budget and timelines.
- Ongoing Support: Ensure high-quality production of products and spares, aligning with safety, quality, cost, and delivery targets for first and second-tier suppliers.
- Continuous Improvement: Drive production process enhancements to support the company's continuous improvement initiatives.
- Change Management: Support obsolescence change requests, including technical evaluations as an expert in electrical components, and assist in verification testing.
- Specialist Support: Act as a specialist in PCBA manufacture, automatic and manual assembly, and testing of electrical and electronic components.
- Documentation Management: Maintain configuration management of engineering change documentation in compliance with quality management system requirements.
Requirements:
- HNC, HND, or Degree in Electronic Engineering (or equivalent).
- Experience in regulated environments, ideally within the medical device industry.
- Strong communication skills, both verbal and written, including technical writing.
- Demonstrated problem-solving abilities and project management skills.
About Us:
We are Remote People, a leading US-based medical technology company committed to advancing health through innovation. Our collaborative environment fosters creativity and problem-solving, and we offer opportunities for professional growth and advancement.
Estimated Salary: $80,000 - $110,000 per annum, depending on qualifications and experience.
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