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Purpose of the Position:
Mechanical design, development and validation of DNA array-based products for diagnostics applications. Develop technical and engineering solutions to products and manufacturing process development and optimization within the Systems Development department. Work with Manufacturing and Quality Control departments to transfer product design to commercial production in a manner compliant with ISO and FDA regulatory and design control requirements.
Essential Duties and Responsibilities (other duties may be assigned):
- Independently design disposable microfluidic devices for IVD applications.
- Design and perform experiments to optimize the performance of DNA diagnostic products (including hardware and consumables).
- Perform the optimization and characterization of product manufacturing processes. Make material and process selection.
- Perform data analysis and failure analysis.
- Coordinate multiple external vendors in developing processes to produce high-quality and cost effective components. Work with external vendors to troubleshoot issues related to product manufacturing.
- Contribute to the design and development of automated manufacturing systems.
- Work with the manufacturing group in developing effective and efficient methods for automated manufacturing.
- Assist in the development and integration of machine vision systems for inspection and manufacturing.
- Work with other groups to study and improve system performance.
- Document product design, engineering procedures, testing results, and development history to meet ISO standards and FDA QSR requirements.
- Plan, coordinate and document internal verification and external validation of product performance.
Supervisory Responsibilities:
None
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Essential:
- 5~ 10 years experience with mechanical design and manufacturing of disposable IVD products.
- Ability to perform engineering design and optimization of microfluidic devices for cost reduction, reliability, and manufacturability.
- Strong mechanical engineering background; Strong mechanical design skill using Solidworks.
- Working knowledge of design of experiments, interpretation of test results, failure investigation and root cause failure analysis.
- Experience with development of automated manufacturing systems.
- Knowledge of injection molding and other plastic fabrication methods.
- Experience with optical inspection and machine vision system development.
- Organizational, planning and detail follow-up skills required.
- Must be proficient in document preparation and editing, including detailed test planning and report writing.
- Must have integration, analytical and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system interoperability problems.
- Ability to work in a team environment and work under stressful conditions.
- Demonstrated ability to deal with outside vendors.
Desired
- Experience in an FDA regulated medical device product development environment.
- Experience with diagnostic products involving fluidic transfer and electrochemical detection.
- Knowledge and experience with Microfluidics and integrated sample-to-answer system.
- Material science background.
- Understanding of basic molecular biology and chemistry principles employed in IVD industry.
- Demonstrated ability to operate a pilot manufacturing lab.
- Previous experience in a post-startup or small company environment.
Education and Experience:
B.S. degree or equivalent in mechanical engineering, physics, bioengineering, test engineering or a related field and 5 or more years of relevant experience.
Language Skills: Must be proficient in writing, and communicating in the English language.
Reasoning Ability: Good problem solving, judgment and decision making skill are required.
Certifications, Licenses, Registrations:
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood Bourne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate. |
