Job Title:

Department:

Reports To:

Location: 

FLSA Status:

Days/Hours:

Field Service Engineer (FSE)

Technical Services/Commercial Operations

Manager, Technical Services

Mid-West Region

Exempt

Variable

 

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Purpose of the Position:

Position will support both the customer and corporate equipment instrument needs for internal and field based systems.

 

Essential Duties and Responsibilities (other duties may be assigned):

 

  • Installs, troubleshoots and repairs commercial field and company based Osmetech instruments by telephone or at customer sites, as necessary.
  • 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.
  • Supports the design and development of new products, test equipment and existing products from a customer perspective.
  • Maintains field service tools and spare parts inventories at acceptable, defined levels and in good condition for Osmetech instrumentation.
  • Develops specifications, design documents, test protocols and other documentation in accordance with FDA and other regulatory agencies.
  • Assists in the development and validation of Technical Service bulletins and other field service support related procedures.
  • Keeps management informed on customer support issues, complaints and quality issues to ensure customer satisfaction and product quality.
  • Participates in technical services, quality and development meetings and seminars, as required.

 

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.

 

  • Ability to troubleshoot analogue and digital electronics systems.
  • Basic knowledge and experience with software programming.
  • Experience developing electronic devices under FDA design control requirements; Quality System Regulations, document control and quality assurance knowledge preferred.
  • Excellent facilitation, leadership, teamwork, time management and organization skills.
  • Experience in the medical device, IVD, or biotechnology industries, preferably directly involved in commercial product development.
  • Good customer service skills to include verbal and written communications.
  • Knowledge of chemistry or biochemistry preferred.
  • 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.

 

Education and Experience:

Bachelors of Science degree in Electrical Engineering preferred. A minimum of three years of direct customer support/instrument service experience for a clinical/research laboratory. Knowledge of FDA quality regulations and design controls.

 

Language Skills:  Must be proficient in writing and speaking the English language.  

 

Mathematical Skills:  Must be consistent with BS, engineering level or higher education.

 

Reasoning Ability:  Good problem solving, judgment and decision making skill are required.

 

Certifications, Licenses, Registrations: None required.

 

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, and laboratory bench or automated machine. Work may involve occasional climbing or balance.  Work entails occasional lifting and/or moving up to 70 pounds.  Work requires travel to customer and corporate sites by airplane and/or automobile. 

 

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.

 

Travel:  Up to 70% travel is required for field service, including air and automobile travel.

 

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 borne pathogens, automated equipment, and high levels of noise and vibration.  The noise level in the work environment is usually moderate. Must be able to wear PPE (including gloves and lab coats) for extended periods of time.