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 | Home and Manufacturing Site

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 & Experience 

• 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.
• Fluency in Romanian is a plus. 

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.
• Innovative Impact: Be at the forefront of advancements in one of the world’s leading injection molding companies.