.Horizons is seeking a dynamic Manufacturing Engineer focused on Electrical and Electronic systems to join a leading US-based medical technology company, recognized as one of the largest global players in advancing health through innovation.
In this pivotal position, you will be responsible for site-based manufacturing activities related to the implementation, qualification, and sustaining of a range of electro-mechanical products.
Your expertise will be essential in managing new product implementations, production ramp-ups, and problem-solving, all while adhering to the highest quality standards in a regulated environment.
Contract Location: Permanent, Full time Oradea, Hybrid: Key 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.
Cross-Functional Collaboration: Engage with various teams to ensure compliant execution of quality systems and processes.
Qualifications HNC, HND, or Degree in Electronic Engineering (or equivalent).
2+ years of experience in post-release design or engineering support of medium-volume electro-mechanical products; 5+ years preferred.
Proficiency in assembly and manufacturing processes, particularly in electrical/electronics assembly.
Familiarity with IPC standards and production line quality control techniques.
Experience in regulated environments, ideally within the medical device industry.
Strong communication skills, both verbal and written, including technical writing.
Knowledge of validation processes (TMV, IQ, OQ, PQ) and quality systems (cGMP, CFR820, ISO13485).
Demonstrated problem-solving abilities and project management skills.
Why You'll Like Working Here: Professional Growth: Take charge of your career with opportunities for advancement while working on innovative projects that make a real impact in healthcare.
Global Exposure: Travel the world as you engage in cutting-edge medical technology initiatives.
Collaborative Environment: Work alongside passionate professionals in a culture of trust and integrity, fostering creativity and problem-solving.
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