Job Title: Manufacturing Engineer – Medical Device Industry
Location: Amersfoort Region, The Netherlands
Company Overview:
Join a dynamic medical device company in the Amersfoort region, dedicated to delivering life-enhancing healthcare products. We strive for operational excellence and innovation while adhering to the highest industry standards.
Position Overview:
We are seeking an experienced Manufacturing Engineer. You will play a pivotal role in optimizing manufacturing processes, ensuring efficiency, and maintaining compliance with regulatory requirements.
Key Responsibilities:
* Develop, implement, and optimize manufacturing processes for medical devices.
* Identify and resolve production challenges to improve efficiency and reduce costs.
* Collaborate with cross-functional teams to enhance product quality and reliability.
* Author and review technical documentation, including process validation and work instructions.
* Ensure compliance with regulatory standards such as ISO 13485, FDA, and EU MDR.
* Support continuous improvement initiatives, including Lean and Six Sigma methodologies.
* Train and mentor production staff on new processes and best practices.
Qualifications:
* Bachelor’s degree in Mechanical, Industrial, or Manufacturing Engineering (or related field).
* 3+ years of experience in manufacturing engineering, preferably in the medical device or pharmaceutical industry.
* Strong understanding of Lean Manufacturing and Six Sigma principles.
* Proficiency in technical writing and process documentation.
* Familiarity with regulatory requirements (ISO 13485, FDA, EU MDR).
* Excellent problem-solving, organizational, and communication skills.
Preferred Skills:
* Experience with automation and process validation.
* Certification in Lean/Six Sigma (Green or Black Belt).
* Hands-on experience with CAD software and ERP systems.
How :
Interested candidates are encouraged to submit their resume and cover letter to (email address or application portal link).
We are an equal opportunity employer and welcome applicants from all backgrounds.
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