Information Technology Engineer (Senior Manufacturing Engineer - Medical Device Equipment)
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Overview
Remote
On-site
Compensation
$34-$34/hour
Job Description
Job Overview:
- Manufacturing Engineer, Foundry, Packaging, Cleanroom, Equipment validation, Process Validation, IQ, OQ, PQ, Product transfer and Manufacturing transfer
- Good communication.
- Has worked in a Packaging, Cleanroom, Equipment machine shop environment (within med device or aerospace preferred).
- Understanding of different types of metal/plastic cutting manufacturing processes.
- Understanding of basic Quality systems
- Need to have good knowledge of tool design and fabrication methods.
- This position will involve overseeing the maintenance and calibration of critical equipment-systems.
- Other necessary manufacturing engineer skills include project management ability, commitment to quality, and familiarity with safety and environmental standards.
- Hands on experience in Quality Control and Regulatory Compliance in Implant Manufacturing.
- Experience in FDA Regulations and ISO Standards: 21 CFR, Quality system regulation (Part 820), establishment registration (Part 807), and unique device identification (Part 830). ISO 11607-1 and 11607-2 updates require usability studies for medical device packaging.
- The candidate should have a strong background in manufacturing, mechanical, production, biomedical engineering or other related disciplines.
- 6+ years of Working Experience machine shop environment
Must Have Skills, Experience:
- Equipment Validation Expertise: Must have experience in overseeing the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes to ensure equipment meets required standards.
- Regulatory Compliance Knowledge: Must have a strong understanding of FDA regulations (21 CFR Part 820, Part 807, Part 830) and ISO standards (ISO 11607-1 & 11607-2), especially in the medical device industry.
- Quality Control Experience: Must have hands-on experience with quality control systems, including monitoring, inspection, and testing to maintain high product standards.
- Packaging and Cleanroom Familiarity: Must be familiar with cleanroom protocols, medical device packaging processes, and environmental control requirements.
- Tool Design and Fabrication: Must have in-depth knowledge of tool design and fabrication methods, especially in metal and plastic cutting manufacturing processes.
- Manufacturing and Product Transfer Experience: Must have experience managing manufacturing and product transfers, ensuring smooth and efficient scaling of production processes.
- Project Management Skills: Must have strong project management abilities, including the planning, coordination, and execution of manufacturing engineering initiatives.
- Mechanical and Biomedical Engineering Background: Must have a solid background in mechanical, manufacturing, or biomedical engineering to address technical challenges and solutions.
- Equipment Maintenance and Troubleshooting: Must be capable of maintaining and troubleshooting critical equipment-systems to ensure smooth manufacturing operations.
- Problem-Solving Abilities: Must have strong problem-solving skills to analyze and resolve complex manufacturing issues in a timely and efficient manner.
- Safety and Environmental Standards Awareness: Must have a good understanding of safety regulations and environmental standards in a manufacturing environment.
- Excellent Communication Skills: Must possess excellent communication skills to collaborate effectively with cross-functional teams and document processes and findings clearly.
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FAQs About Information Technology Engineer (Senior Manufacturing Engineer - Medical Device Equipment) Jobs at Macpower Digital Assets Edge Private Limited
What is the work location for this position at Macpower Digital Assets Edge Private Limited?
This job at Macpower Digital Assets Edge Private Limited is located in Raynham, MA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Macpower Digital Assets Edge Private Limited?
Candidates can expect a pay range of $34–$34 per hour for this role.
What employment applies to this position at Macpower Digital Assets Edge Private Limited?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Macpower Digital Assets Edge Private Limited?
You can apply for this role at Macpower Digital Assets Edge Private Limited either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.