Sr. Disposables R&D Technician

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Works collaboratively with a cross functional team to support product development needs
• Under limited supervision, applies considerable technical knowledge to perform a broad range of tasks which include but are not limited to participating in all phases of the product development cycle.
• May assist lead technicians/engineers in data analysis, statistics, and trend analysis.
• Write or update test procedures
• Write reports discussing results, which may include qualitative or quantitative data analysis with graphical representation of data using various statistical techniques. May present updates of research/work at project team meetings as required.
• Assist senior level staff in developing new techniques, test methods (TMs) and performing validations on TMs or test systems.
• Assist lead technician/supervisor in scheduling testing and ensuring smooth operation of the laboratory.
• Works with issues of moderate scope where analysis of situation or data requires a review of a variety of factors.
• Work on assignments requiring considerable judgment and initiative. Understands implications of work and makes recommendations for solutions.
• May provide assistance to junior level staff with general tasks that require a better understanding of functions.
• Update part and product specifications, including 3D solid models and drawings
• Builds prototypes for testing
• Set-up, adjust, and operate various types of equipment and instruments.
• Perform experiments for development projects under limited guidance and supervision of immediate supervisor/lead technician.
• Test samples of manufactured products to verify conformity to specifications.
• Record test results on standardized forms and maintain good documentation practices.
• Maintain order and cleanliness of laboratory space
• Exercise professional capability to properly apply company policies and procedures.
• Build productive working relationships.
• Refer to senior level staff for assistance with complex problems that may arise.
• Escalate issues to supervisor/manager as necessary.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Regular attendance and maintaining a good attendance record is an essential function of the job.
• Maintain laboratory notebook in accordance with standard procedures and cGMP.
• Maintain general housekeeping of working area.
• Other duties as assigned.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and 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.
• While performing the duties of this job, the employee is frequently required to talk or hear, stand, walk and use hands to finger, handle, or feel. The employee is occasionally required to sit; reach with hands and arms. The noise level is usually moderate.
• required to wear personal protective equipment that may include safety glasses, smock, steel-toed shoes, etc.
• Occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock.
• Occasionally lift or move up to 50 pounds.
• The employee may also be required to work with human or bovine blood, plasma, or serum.
• The employee may be required to work with potentially hazardous materials and solutions.
• Hepatitis B vaccination is strongly recommended.
• Occasional travel may be required.

EDUCATION:

• Associates Degree or equivalent experience required. Bachelor's Degree desired or equivalent experience.

EXPERIENCE AND REQUIRED SKILLS:     

• Trade school, technical training and/or technical certification
• 4 - 6 years related experience; or equivalent directly related work experience.
• Experience in the Medical Device Industry is preferred.
• Experience with disposable medical devices is preferred.
• Basic understanding of CAD software (Solidworks) is preferred
• Familiarity with machining processes and equipment (lathe, mill, etc) is preferred
• Must be detail oriented and capable of reading and interpreting documents such as safety rules, operating and maintenance instructions, procedure manuals, drawings, specifications, and data results.
• Must be capable of writing routine reports and correspondence and speak effectively before groups of customers or employees of the organization.
• Solve practical problems and deal with a variety of variables in situations where only limited standardization exists.
• Must be capable of interpreting a variety of instructions furnished in written, oral, diagram, or schedule form.
• Must have good organizational skills, and be able to perform work in a team environment with a minimum level of supervision.
• Must have an aptitude for math with basic algebraic skills such as, conversion of units, calculations of surface area, mass weights, and measurements skills.
• Strong PC skills with proficiency in Microsoft Office applications.
• Understand and apply FDA Guidelines, standards (ISO/AAMI/USP), and Design/Pharma Control Concepts.
• Strong oral and written communication skills.

The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies.

Hourly Rate: $30 - $51

Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave.
 

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.