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A leading medical device manufacturer seeks a Production Manager to oversee production staff. Responsibilities include supervising operations, ensuring quality compliance, and promoting a team-based environment. The ideal candidate will have substantial supervisory experience and excellent mechanical skills, with proficiency in both English and Spanish.
The Production Manager is responsible for production staff in a hands-on leadership role, with the responsibility to provide oversight, supervision, and development employees in a team environment. The Production Manager is responsible for the execution of established work instructions, SOP’s, equipment maintenance, cleaning and hygiene procedures used to produce finished goods product. Oversees training of new employees as it relates to manufacturing and related processes. Ensures documentation is completed for training. Production Manager is also responsible for oversight and assistance with all aspects of safety of personnel in the manufacturing process. The Production Manager assists Manufacturing Engineer(s) ensuring product meets all aspects of the Quality System and Regulatory guideline in compliance with ISO 13485 and FDA guidelines.
Primary Responsibilities:
•Supervise production staff 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.
•Provide training and support to ensure all personnel are 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.
•Assist with all equipment maintenance requirements to ensure a safe work environment and a high overall equipment effectiveness.
•Escalate equipment faults above production operators fault resolution capabilities to Manufacturing Engineering team as needed.
•Work with other departments to meet relevant company goals and objectives.
•Ensure compliance with ISO 13485 and FDA/QSR regulations.
•Ensure enough raw material is at each workstation to complete the day’s assembly.
•Write and give performance reviews for team members.
•Create, communicate, and drive key operating metrics for quality and build plan, FPY, line capacity, tact times, equipment maintenance etc. for manufacturing and service
•Establish and manage continuous improvement system for the production team e.g. lean techniques
•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.
•Improving manufacturing related SOP’s and generating new ones as required.
•Promotes a culture of continuous improvement, reinforces the elimination of process waste and supports business improvement and profitability
•Compliance with all personnel policies
•Frequent execution of lifting supplies and parts weighing up to 50lbs.
•Must be able to alternate walking, standing & sitting shift
•Frequent execution of repetitive motion.
•Must wear clean room clothing for shift including but not limited to jacket, safety glasses, and hair net.
Position Requirements - Education, Knowledge, Years of Experience, etc.:
•The Production Manager should have a high school diploma or equivalent.
•The Production Manager should have prior supervisory experience in a manufacturing environment or equivalent.
•Excellent written and verbal communication skills in English and Spanish at the professional level.
•Excellent mechanical and/or electromechanical skills are required, along with an inherent understanding of electromechanical devices, and the ability to troubleshoot a variety of systems.
•Previous supervisory experience in an ISO environment is ideal with FDA related experience a plus.
•Leadership skills to teach, train, and lead others in the manufacturing process.
•An ability to use measuring devices, work with small components, and record detailed information is required.
•Experience developing work instructions, procedures, and implementation of those instructions is ideal.
•Computer skills using Microsoft Office products and ERP are required.
Summary of Position:
The Production Manager is responsible for production staff in a hands-on leadership role, with the responsibility to provide oversight, supervision, and development employees in a team environment. The Production Manager is responsible for the execution of established work instructions, SOP’s, equipment maintenance, cleaning and hygiene procedures used to produce finished goods product. Oversees training of new employees as it relates to manufacturing and related processes. Ensures documentation is completed for training. Production Manager is also responsible for oversight and assistance with all aspects of safety of personnel in the manufacturing process. The Production Manager assists Manufacturing Engineer(s) ensuring product meets all aspects of the Quality System and Regulatory guideline in compliance with ISO 13485 and FDA guidelines.
Primary Responsibilities:
•Supervise production staff 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.
•Provide training and support to ensure all personnel are 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.
•Assist with all equipment maintenance requirements to ensure a safe work environment and a high overall equipment effectiveness.
•Escalate equipment faults above production operators fault resolution capabilities to Manufacturing Engineering team as needed.
•Work with other departments to meet relevant company goals and objectives.
•Ensure compliance with ISO 13485 and FDA/QSR regulations.
•Ensure enough raw material is at each workstation to complete the day’s assembly.
•Write and give performance reviews for team members.
•Create, communicate, and drive key operating metrics for quality and build plan, FPY, line capacity, tact times, equipment maintenance etc. for manufacturing and service
•Establish and manage continuous improvement system for the production team e.g. lean techniques
•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.
•Improving manufacturing related SOP’s and generating new ones as required.
•Promotes a culture of continuous improvement, reinforces the elimination of process waste and supports business improvement and profitability
•Compliance with all personnel policies
•Frequent execution of lifting supplies and parts weighing up to 50lbs.
•Must be able to alternate walking, standing & sitting shift
•Frequent execution of repetitive motion.
•Must wear clean room clothing for shift including but not limited to jacket, safety glasses, and hair net.
Position Requirements - Education, Knowledge, Years of Experience, etc.:
•The Production Manager should have a high school diploma or equivalent.
•The Production Manager should have prior supervisory experience in a manufacturing environment or equivalent.
•Excellent written and verbal communication skills in English and Spanish at the professional level.
•Excellent mechanical and/or electromechanical skills are required, along with an inherent understanding of electromechanical devices, and the ability to troubleshoot a variety of systems.
•Previous supervisory experience in an ISO environment is ideal with FDA related experience a plus.
•Leadership skills to teach, train, and lead others in the manufacturing process.
•An ability to use measuring devices, work with small components, and record detailed information is required.
•Experience developing work instructions, procedures, and implementation of those instructions is ideal.
•Computer skills using Microsoft Office products and ERP are required.
Vapotherm Inc. is a publicly held corporation based in Exeter, New Hampshire that was founded in 1999 as a medical device manufacturer after creating the first heated and humidified high flow therapy nasal cannula system.
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