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.
To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesineu.com) you saw this job posting.
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