Manufacturing Engineer || Injection Molding & Tooling Oradea

Manufacturing Engineer || Injection Molding & Tooling
Oradea
Oradea, Bihor County, Romania

We specialize in connecting
- thinking companies with outstanding global talent. Whether you’re looking to fill a critical role or expand into new markets without local offices, we’re here to support you every step of the way.

Horizons is seeking a dynamic Manufacturing Engineer focused on Injection Molding & Tooling to join a leading US-based medical technology company, recognized as one of the largest global players in advancing health through innovation.

In this key position, you'll lead site and
- based manufacturing activities to implement, qualify, and sustain a range of
- mechanical products. Your expertise in injection molding and tooling will be vital in managing tool assets, optimising processes, and ensuring the highest quality standards.

Contract & Location

• Permanent, Full time
• Oradea, Hybrid | Home and Manufacturing Site

Key Responsibilities

• Tool Management: Collaborate with contract manufacturers to design, implement, and validate injection molding tools and processes, ensuring compliance with product specifications and quality criteria.
• Production Support: Ensure the ongoing manufacture of
  - quality products while meeting safety, quality, cost, and delivery targets for first and
  - tier suppliers.
• Continuous Improvement: Drive process enhancements to meet the company's improvement goals, focusing on tooling, polymer manufacturing, and metrology.
• Cost Optimization: Implement design iterations to reduce costs while enhancing patient safety for BD products.
• Documentation Management: Maintain configuration management of engineering change documentation in line with quality management system requirements.
• Cross-Functional Collaboration: Engage with various teams to ensure compliant execution of quality systems and processes.
• Global Travel: Be prepared to travel internationally to manage tool trials and process development.

Qualifications & Experience 

• HNC, HND, or Degree in Engineering (or equivalent).
• 3+ years of experience in injection molding and tooling, ideally with
  - volume products.
• Proficiency in
  - mechanical assembly, machining, and plastic injection molding.
• Knowledge of scientific molding techniques and production line quality control.
• Experience in regulated environments, preferably in medical devices.
• Strong communication skills, both verbal and written, including technical writing.
• Familiarity with validation processes (TMV, IQ, OQ, PQ) and quality systems (c
  GMP, CFR820, ISO13485).
• Demonstrated
  - 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
  - edge medical technology initiatives.
• Collaborative Environment: Work alongside passionate professionals in a culture of trust and integrity, fostering creativity and
  - solving.
• Innovative Impact: Be at the forefront of advancements in one of the world’s leading injection molding companies.