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Manufacturing Engineer Bioptigen
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Description:Bioptigen is seeking a Manufacturing Engineer to support the production of Fourier Domain Optical Coherence Tomography imaging systems. Responsibilities will include all aspects of manufacturing and production of released product, pilot builds of new product, and hardware and software upgrades to existing products. The Manufacturing Engineer is also responsible for assuring that manufacturing activities comply with the requirements of FDA and ISO corporate Quality Systems, and maintaining an ISO 13485 and FDA ? QSR complaint manufacturing environment.
Bioptigen is a leader in providing high performance optical coherence tomography imaging systems to the translational research and clinical ophthalmology communities. We are seeking passionate multi-talented individuals to join our dynamic environment. We offer the motivated candidate a unique opportunity to contribute to next generation optical imaging and analysis systems for life science applications in an open, team-based environment.
Responsibilities:
This position reports to the Director of Operation and is responsible for assuring the cost effective, timely manufacture of high quality imaging systems. Specific areas of responsibility include the following:
Manufacturing Engineering:
Design, develop and validate manufacturing assembly and test processes and implement engineering and process changes to improve quality, improve performance, reduce costs or substitute materials. Technical support for transfer and manufacturing process establishment for new products from engineering, including prototype and pilot run support. Continuously improve manufacturing and operational business processes to meet quality, regulatory, and efficiency objectives. Monitor and facilitate various product life cycle activities (i.e. design control).
Improve manufacturing efficiency by analyzing and planning work flow, space requirements and equipment layout
Troubleshoot product performance issues to resolution
Support new product transition from engineering to production
Prepare assembly process flow documents and work instructions
Quality Systems Maintenance:
Responsible for the development and implementation of processes that are compliant to ISO 13485 and FDA-QSR quality system regulations for medical devices. Support the implementation of processes that provide actionable, measurable quality metrics to enable continuous quality improvement. Ensure that any changes to the documented processes are implemented in a timely manner. Report on the performance of the quality system to executive management, including any need for improvement.
Assure product and process quality by designing test methods; evaluating finished product and process capabilities; establishing standards; and validating manufacturing processes
Collect, analyze and summarize information and trends for inclusion into product and process reports
Manufacturing Execution:
Ensure the production and delivery of the highest quality products with predictable lead times. Support on-going operations department activities; including, material and inventory management, procurement, document change control and support for production activities.
Calibrate and maintain production and test equipment
Train production and technician staff.
Manufacturing Materials and Service Providers Management:
Support the resolution of vendor material and quality problems and work with vendors to assure control of costs and stability of supply.
Assure component specification compliance with input from inspections and vendors
Support the qualification of vendors and custom vendor processes to support manufacturing activities
Qualifications:
Bachelor?s Degree or Master?s Degree in an Engineering discipline from an accredited college/university
BS or MS in Optical, Electrical, Mechanical, Industrial, or Manufacturing Engineering
5-8 years hands on experience with the assembly and test of fiber optic, opto-mechanical, electro-mechanical and electro-optical systems.
Working knowledge of laboratory equipment, such as oscilloscopes, multi-meters and power meters
Ability to read and understand mechanical drawings and electrical wiring diagrams
Strong troubleshooting skills
Minimum 3 years experience in medical device industry
Mechanical, optical/optomechanical assembly
Change management experience
Excellent skills in MS Excel and Access
Root cause analysis
Comfort with working in a dynamic and innovative environment with significant demands on New Product Introduction
Desire to work in a dynamic entrepreneurial environment
Demonstrated high levels of integrity, maturity and judgment
Exceptional organization and communication skills
Results oriented
Additional attributes:
Experience with new product development, design control, and other product life cycle activities
Experience with medical device product development or other highly regulated manufacturing environment
Demonstrates integrative problem solving skills ? coordinating resources, technical issues, and external constraints
Strong project management skills
Personal attributes:
Detail oriented
Strong communication skills
Willing to engage to solve problems directly with focus on facts and objectives
Willingness to learn
| Location: | 104 T.W. Alexander Drive Park Research Center, Building 2 Research Triangle Park, NC 27709 United States |
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THIS JOB HAS EXPIRED
Bioptigen
All Jobs: at Bioptigen| Web Site: | www.bioptigen.com |
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| Headquarters: | 104 T.W. Alexander Drive Park Research Center, Building 2 Research Triangle Park, NC 27709 United States |
| Industry: | Medical Devices and Equipment |
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