Posted 3w ago

Manufacturing Engineer, Senior Staff

@ Confluent Medical Technologies
Alajuela, Costa Rica, Costa Rica
OnsiteFull Time
Responsibilities:lead manufacturing, improve processes, supervise staff
Requirements Summary:Bachelor's in engineering; 6-7 years in manufacturing, preferably medical devices; advanced English.
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Job Description

Job Description:

At Confluent, we are committed to our values of teamwork, innovation, accountability, integrity, leadership, and customer focus, and we invest in a team who represents these values. Every member of our team plays a critical role in delivering life-saving medical devices through innovative materials science, engineering, and manufacturing. We are the medical device industry's most trusted partner, and we accomplish this with an organization focused on safety, efficiency, and customer satisfaction.

We are looking for a Manufacturing Engineer, Senior Staff to join our team in Costa Rica. If you enjoy working in a fast-paced environment and making an impact on our life-saving work, this may be a good fit for you! As a uniquely qualified candidate, you will:

SUMMARY: Works on problems and projects of moderate scope where analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Demonstrates full use and application of standard principles, theories, concepts and techniques. Selects design direction or modifications of components of systems. Participates in decisions on scope of work, selection of equipment and length of task. Decides on design changes to meet revised specifications. Provides and develops solutions to problems of limited scope. Must be able to accomplish broad and complex assignments. May provide technical guidance to lower level personnel.

ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.

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.
  • Develops, implements and monitors manufacturing process controls and machinery modifications (re-engineering).
  • Designs layouts for production lines.
  • Independently performs most assignments with instructions as to the general results expected
  • Responsible for design/development of equipment, tools or fixtures that meets health, safety and environmental standards set by the company for manufacturing methods.
  • Participates and approves design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes
  • Setups and validates production lines for manufacturing as applicable.
  • Leads product transfers, and new product introductions
  • Provides technical supervisory and coordinates the work of engineers, draftspersons, technicians, and others who assist in the specific assignments.
  • Builds business relationship with customer and/or suppliers.
  • Investigate, respond and solve quality issues, or provides supports for that process as required.

SUPERVISORY RESPONSIBILITIES:

Have supervisory responsibilities: Yes                                 

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

Supervises:

  • Manufacturing Engineer I, II and Staff
  • Equipment Technician I, II, III, Sr.

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, with 6-7 years of experience. Experience in the medical device industry would be an asset. Advanced English Level. Intermediate personal computer skills, including electronic mail, routine database activity, word processing, spreadsheet and graphics.

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, workflow, 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
  • OPEX -Advance Quality Tools: Methodologies, Green Belt or upper
  • Conduct meetings in a structure manner.
  • Provides updates in a structure manner.
  • Ability to work under pressure
  • Ability to work with little supervision
  • Analytical skills
  • Leadership
  • Mentoring
  • Business visioning (able to see the big picture)
  • 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. 
  • Supervisory skills and experience desired.

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.