Production / Manufacturing Engineer Manager

Vapotherm; Tijuana; Presencial; MXN 1,260,000 - 1,621,000; Jornada completa

Descripción de la vacante

A medical manufacturing company in Tijuana is seeking a Production Supervisor to oversee engineering staff and ensure compliance with ISO and FDA guidelines. This hands-on role requires strong leadership skills, a background in Lean Manufacturing, and the ability to speak English and Spanish fluently. Responsibilities include training staff, maintaining safety, and driving quality metrics. Candidates must have a Bachelor's Degree in Engineering and 7-10 years of experience in a relevant field.

Formación

• 7-10 years of experience in engineering and manufacturing.
• Knowledge of FDA regulations and ISO requirements.
• Experience in Lean techniques and continuous improvement.

Responsabilidades

• Supervise production staff and ensure compliance with SOPs.
• Drive continuous improvement and training of workforce.
• Write and maintain team objectives and goals.

Conocimientos

Leadership

Lean Manufacturing

Statistical Process Control (SPC)

Excellent communication skills

Bilingual in English and Spanish

Educación

Bachelor's Degree in Engineering

Herramientas

Microsoft Office

SolidWorks

Descripción del empleo

Summary of Position

This role will be responsible for the supervision of production and engineering staff.

This staff will be involved in the execution of established work instructions and SOP's to perform assembly of medical products using manual processes as well as semi-automated manufacturing machines.

This position will also oversee processes related to equipment maintenance management, continuous improvement, cleaning / hygiene procedures, overall facility safety, and chemical control.

This position will also oversee the training of manufacturing department employees and ensure documentation is completed for training.

This position must ensure procedures are in place and followed to meet ISO and FDA guidelines for compliance.

This is a hands‑on leadership role, with the responsibility to provide oversight, supervision, and development employees in a team environment.

Primary Responsibilities

• Supervise manufacturing department in the execution of established work instructions, cleaning and hygiene procedures, and equipment maintenance.
• Develop and maintain a positive team‑based working environment in which the team takes pride in exceeding plans and quality standards.
• Ensure all personnel is properly trained to perform their job, ensuring the training is well documented.
• Oversee and assist with all personnel safety aspects of the manufacturing department to ensure safe work practices are adhered to.
• Oversee and assist with all equipment maintenance requirements to ensure a safe work environment and a high overall equipment effectiveness.
• Work with other departments to meet relevant company goals and objectives.
• Ensure compliance with ISO and FDA / QSR regulations.
• Write and maintain team goals, objectives, and reviews.
• Create and drive metrics for quality and build plan, FPY, line capacity, tact times, equipment maintenance etc.
• Establish and manage continuous improvement system for the manufacturing department.
• Drive new product introduction to full production
• Compliance with all personnel policies
• Frequent execution of lifting supplies and parts weighing up to 50lbs.
• Provide cross‑functional leadership to set and maintain the proper rigor for transfers of new products into manufacturing.
• Ensure problems within manufacturing are identified, prioritized, and resolved in a timely manner.
• Prepare manufacturing proposals, cost estimates and capital appropriation requests.
• Represent Manufacturing during new product design phases.
• Setting and realizing in‑process quality and identified functional objective goals.
• Improving manufacturing related SOP's and generating new ones as required.
• Manage improvement projects and project budgets.
• Ensure that goals and objectives are clearly communicated and executed to plan.
• Identifies opportunities to improve processes, e.g., lean techniques
• Promotes a culture of continuous improvement, reinforces the elimination of process waste and supports business improvement and profitability

Position Requirements - Education, Knowledge, Years of Experience, etc.

• Bachelor's Degree or equivalent, in a technical field; with Manufacturing, Mechanical, Electrical, or Industrial engineering degrees preferred.
• 7 - 10 years of related experience with a wide range of engineering, design, and computer skills.
• Able to speak, understand, and write in English and Spanish at the professional level.
• Able to travel to the US
• Thorough knowledge of FDA Quality System Regulations and ISO Quality Stems Requirements is preferred.
• Leadership skills to teach, train, and lead others in the manufacturing process.
• Expertise with SPC, Experimental Design, and Statistical Sampling techniques.
• Working knowledge of SolidWorks is preferred.
• Deep knowledge of fabrication methodology is preferred.
• Excellent written and verbal communication skills
• Computer skills using Microsoft Office products are required.
• Must have experience with and demonstrable competencies in Lean Manufacturing (e.g. Toyota Production System).
• Including leading Kaizens / Continuous Improvement techniques, Standard Work, Single Piece Flow, Kan Ban, 5S, SMED, Value Stream Mapping, and Poka Yoke

Able to travel to the US

Work Environment

• While performing the duties of this job, the employee is regularly required to sit and / or stand for extended periods of time for meetings or work, travel to different locations via car or airplane, operate a motor vehicle, operate a personal computer, visually inspect reports / forms, conduct oral communication via telephone or in person, retrieve and return files, and occasionally lift up to 25 pounds.

Equal Opportunity Employer Minorities / Women / Protected Veterans / Disabled