NonStop Consulting
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 to Apply:
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.
