
Medical Device Production Engineering Director
11 hours ago
Nordberg Medical Production Process Engineer:
We are seeking a highly experienced Production Process Engineer to lead the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices. As a key member of our production team, you will be responsible for designing, developing, and optimizing manufacturing processes, collaborating with cross-functional teams, and ensuring compliance with regulatory standards.
Main Responsibilities:
- Design, develop, and optimize manufacturing processes for new and existing products.
- Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and efficient process implementation.
- Support the installation and validation of new equipment, ensuring it meets process requirements and regulatory standards.
Requirements:
- Around 5-8 years of experience in process engineering within the pharmaceutical or medical device industry with Class III product experience.
- Bachelor's degree in engineering or related field; master's degree is a plus.
- Strong understanding of GMP, ISO 13485, FDA 21 CFR Part 820 regulatory requirements.
- Experience with cleanroom operations – Class A to C.
- Fluency in English (verbal and written).
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