Scanogen Inc. is a rapidly growing start-up developing a revolutionary platform for infectious disease detection. Apply to work with us if you want to be part of a company pushing the boundaries of medical diagnostics.
Working at Scanogen is a tremendous opportunity to grow alongside a start-up company at the forefront of its field.
Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first.
POSITION TITLE :
Senior Manufacturing Engineer - Medical Device Industry
LOCATION :
Windsor Mill, Maryland, United States
JOB SUMMARY :
Responsible for developing, implementing and optimizing the manufacturing process of plastic disposable medical diagnostic devices and automated instruments in compliance with quality and regulatory standards.
The person will also work closely with R&D, quality assurance, regulatory affairs, and supply chain teams to ensure products are designed for manufacturability, reliability, and quality.
KEY RESPONSIBILITIES :
- Lead the development of manufacturing processes for a disposable cartridge and an automated instrument used in in-vitro diagnostics.
- Develop, implement, and optimize manufacturing processes to enhance efficiency and product quality.
- Identify areas for process improvement and implement changes to reduce waste, increase productivity, and improve product consistency.
- Collaborate with design and quality teams to ensure manufacturability of new products and processes.
- Provide technical support to the production team to resolve manufacturing issues and ensure smooth operations.
- Troubleshoot and resolve equipment and process-related problems to minimize downtime and maintain production schedules.
- Develop and maintain work instructions, process documentation, and standard operating procedures (SOPs).
- Ensure compliance with FDA regulations, ISO 13485, and other applicable regulatory requirements.
- Specify, design, and procure manufacturing equipment, tooling, and fixtures to support production needs.
- Implement corrective and preventive actions to address process inefficiencies and quality issues.
REQUIRED QUALIFICATIONS :
- Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, or a related field.
- 6+ years of experience in manufacturing engineering.
- Strong knowledge of FDA regulations and ISO 13485.
- Experience with laser welding, sonic welding, as well as assembly methods for sheet metal, machined parts, and injection molded parts.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong communication and interpersonal skills.
- Ability to work effectively in a team-oriented environment.
Benefits are provided, including health insurance and 401k with company matching.
To apply for this position, please send an email with the subject line "Senior Manufacturing Engineer" and include your CV and a cover letter to : [email protected]
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