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Position will support both the customer and corporate equipment instrument needs for internal and field based systems.
(other duties may be assigned):
- Assists in making decisions on engineering problems and methods. Requires the use of advanced techniques and the modification and extension of theories and practices of own field and related sciences and disciplines.
- Support the design and development of new products, test equipment and existing products from a customer perspective (voice of the customer).
- Install, troubleshoot and repair commercial instruments internally and in the field. Travel required.
- Responsible for the installation and repairs of field and company based Osmetech molecular diagnostic instruments.
- Maintain field service tools and spare parts inventories for Osmetech molecular diagnostics.
- Develop specifications, design documents, test protocols and other documentation in accordance with FDA and other regulatory.
- Assist in the development and validation of Technical Service bulletins and other field service support related procedures.
- Should have excellent facilitation, communication, leadership, teamwork and organization skills.
- Keep management informed on customer support issues, complaints and quality issues to ensure customer satisfaction and product quality.
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.
- Ability to troubleshoot analogue and digital electronics systems.
- basic knowledge and experience with software programming
- Experience developing electronic devices under FDA design control requirements and be familiar with Quality System Regulations, document control and quality assurance a plus.
- Must have experience in the medical device, IVD, or biotechnology industries, preferably directly involved in commercial product development.
- Good customer service skills to include voice and written communications.
- Knowledge of chemistry or biochemistry would be beneficial.
- Familiarity with industry standards for electronic design and safety such as ASME, IEEE, UL, CSA, CE and others.
- Ability to travel up to 70% of the time.
BSEE desirable plus at least three years experience in a commercial product development environment. Must also have at least three years of direct customer support/instrument service experience for a clinical laboratory. Experience in some or all of the following areas are desired. FDA quality regulations and design controls.
Must be proficient in writing, and communicating in the English language.
Must be consistent with BS, engineering level or higher education
Good problem solving, judgment and decision making skill are required.
None required
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 70 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.
Will start at 40% and grow to up to 70%.
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. |