Manufacturing Engineer I

Posted 8 Days Ago
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Alajuela, Alajuela, CRI
In-Office
Entry level
Healthtech
The Role
The Manufacturing Engineer I works on production methods, quality inspections, and process improvements in the manufacturing of medical devices, while ensuring compliance with regulations.
Summary Generated by Built In

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 I 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 where analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action in order to develop, implement and sustain production processing methods and control to meet company standards.   Participates in decisions within the scope of work.  May provide technical guidance to lower level personnel. Will work with operations and quality teams

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

  • 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.

  • Analyzes and implements improvements to reduce product costs.

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

  • Applied for fixtures and simple machinery

  • Setups and validates production lines for manufacturing as applicable.

  • Applied for Stations / Individual operations.

  • Supports product transfers, and new product introductions

  • Executes

  • Builds business relationship with customer and/or suppliers.

  • Suppliers, and has contact with customers by email (cc. manager)

  • Investigate, respond and solve quality issues, or provides supports for that process as required.

  • NCR and Complains.

SUPERVISORY RESPONSIBILITIES:

Have supervisory responsibilities: No                                  

Leadership: N/A

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 relevant discipline with 0-1 year of related engineering experience. Has a basic intermediate engineering experience. Experience in the medical device industry would be an asset. Intermediate personal computer skills, including electronic mail, routine database activity, word processing, spreadsheet and graphics. 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 became a SME and is able to train others.

  • OPEX - Basic Quality Tools: 5S, Kaizen, Pareto, Ishikawa, Control Charts, Checklist, Histograms

  • Provides updates in a structure manner

  • Ability to work under pressure

  • Analytical skills

  • Teamwork

  • Accountability

  • Attention to detail

  • Excellent problem solving skills

  • Ability to organize and manage multiple tasks and prioritize

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. Shift A

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.

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The Company
HQ: Scottsdale, AZ
1,068 Employees
Year Founded: 1991

What We Do

Confluent Medical Technologies applies materials science to MedTech innovation. Confluent specializes in expert design and development of large-scale manufacturing specializing in interventional catheter-based devices and implants. Our key capabilities include Nitinol components and tubing, balloon and complex catheters, high-precision polymer tubing, and implantable textiles. We operate in 8 state-of-the-art facilities across the United States and Costa Rica and currently employ over 2,000 employees. Confluent has earned the confidence of leaders in the medical device community through a proven track record of innovation, engineering, and manufacturing.

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