Job Description:

ESSENTIAL DUTIES AND RESPONSABILITIES

• Responsible for ensuring personal and company compliance with local and company regulations, policies and procedures for Health, Safety and Environmental compliance.

• Properly document activities in accordance with the best engineering practices, company procedures, and regulatory requirements (technical reports).

• Work with R&D/Design/Development/Transfer Engineers or Customers to understand the products to be produced.

• Able to conduct basic to complex quality visual inspection of parts in accordance with process or other control procedures such as Work Standards.

• Responsible for cost effective manufacturing product/lines through the management of yield, material usage (BOM and consumables).

• Conducts engineering efforts to identify root cause analysis.

• Responsible for the development and implementation of standard manufacturing methods, process and efficiency improvements.

• Conducts engineering efforts to optimize medical component processing for manufacturing (time studies, working standards, process flows, etc).

• Conducts and documents time studies to establish performance standards.

• Executes cost analysis (material, labor and burden) as required.

• Analyzes and implements improvements to reduce product costs.

• Designs layouts for production lines.

• Responsible for design/development of equipment, tools or fixtures that meets health, safety and environmental standards set by the company for manufacturing methods.

SUPERVISORY RESPONSIBILITIES:

Have supervisory responsibilities: No                                  

Leadership: Supervise/manage/direct the selection, training, development, appraisal and work assignments of personnel.

Supervises: N/A

Supervision:

Direction: receive guidance with respect to general objectives; in the majority of tasks and projects assigned, determine methods, work sequence, scheduling, and how to achieve objectives of assignments; operate within specific policy guidelines.

EDUCATION and/or EXPERIENCE: Bachelor´s degree in engineering or related field, +3 years of experience in relevant positions. Intermediate English Level. Experience in the medical device industry and Continuous improvement projects would be an asset. Intermediate personal computer skills, including electronic mail, routine database activity, word processing, spreadsheet, graphics and statistics. Qualifications in statistics, materials and Mechanical knowledge will be a plus.

SKILLS AND COMPETENCES

• Knowledge on Quality and Medical Regulations (focus Process Validation, traceability, manage or quality issues, risk management)
• Technical skills in manufacturing processes and methods including tooling, work flow, layout, assembly and production equipment. Is able to become a SME and is able to train others.
• OPEX - Basic Quality Tools: 5S, Kaizen, Pareto, Ishikawa, Control Charts, Checklist, Histograms
• Conduct meetings in a structure manner.
• Provides updates in a structure manner.
• Ability to work under pressure
• Analytical skills
• Mentoring
• Teamwork
• Accountability
• Ability to organize and manage multiple tasks and prioritize. 
• Attention to detail.
• Recognize a problem and propose solutions. 
• Excellent interpersonal and communication skills. 
• Strong team player, self motivated.
• Excellent problem solving skills. 

MANUAL DEXTERITY: Manual dexterity sufficient to reach/handle items and work with the fingers.

VISION REQUIREMENTS: No special vision requirements

WORK SCHEDULE/HOURS: Monday – Friday.

TRAVEL: Minimal overnight travel.

ENVIRONMENTAL WORKING CONDITIONS

Well-lighted, heated and/or air-conditioned indoor office setting with adequate ventilation.

PHYSICAL DEMANDS

Other physical working conditions:     

Lifting or carrying items.

Moderate noise (examples: business office with computers and printers, light traffic)

PHYSICAL ACTIVITY LEVEL:

Sedentary physical activity performing non-strenuous daily activities of an administrative nature.

COMMENTS:  This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.