Production Supervisor

NextPhase Medical Devices LLC; Mansfield (MA); On-site; USD 34,000 - 48,000; Full time

Job summary

Arterex Medical in Mansfield, MA seeks a Production Floor Supervisor to lead multiple lines, train staff, and ensure on-time, quality builds. You will drive manufacturing excellence on the floor, work with cross-functional teams, and mentor operators in a fast-paced environment.

The role emphasizes hands-on leadership, adherence to ISO 13485:2016 and 21 CFR 820, and a commitment to safety, documentation, and continuous improvement on the shop floor.

Qualifications

• 5+ years in a regulated manufacturing environment.
• Experience with ISO 13485 and FDA QSR requirements.
• Supervisory experience and training ability.
• Cleanroom assembly experience a plus.

Responsibilities

• Lead production lines to meet schedules with quality.
• Train, assign tasks, and mentor team members.
• Uphold safety and GMP/GDP standards.
• Interpret blueprints and assembly instructions.
• Complete regulatory documentation as required.

Skills

Team leadership

Blueprint interpretation

Troubleshooting

Mechanical aptitude

Electrical aptitude

Soldering

Documentation accuracy

Communication

Education

ISO 13485:2016 experience

FDA QSR 21 CFR 820 familiarity

High School diploma

CPIM / CMS a plus

Tools

Torque tools

Calipers / measurement tools

Wire diagrams

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Management Mansfield, MA, Mansfield, MA, US

5 days ago Requisition ID: 1104

Salary Range: $25.00 To $35.00 Hourly

Join Arterex Medical as a Production Supervisor, where you’ll drive high-quality, life-saving manufacturing while building and mentoring a high-performing team. This is your opportunity to take ownership of a production line, solve challenges, and shape a culture of excellence on the manufacturing floor.

Job Summary:

The role of the Production Floor Supervisor is to perform and ensure production assembly tasks are actively completed to meet production schedules while upholding the highest level of Quality. This individual will also work along the side of the team to assemble and make sure projects are completed with time standard. The Production Floor Supervisor will manage multiple production lines to meet production needs and solve issues. This individual will train and assign tasks to the operations team.

Duties/Responsibilities:

• Understand, support, and comply with the Company Quality System requirements.
• Maintain a safe and clean work environment.
• Accomplishes manufacturing results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; and initiating, coordinating, and enforcing systems, policies, and procedures.
• Comply with all safety rules, policies, and procedures.
• Completes production plan by scheduling and assigning employees, accomplish work results, establish priorities, monitor progress, revise schedules, and resolve problems.
• Follow the standard operating procedures and written work instructions.
• Complete required documentation relating to business or regulatory requirements.
• Perform chassis and final build level of product assembly.
• Understand blueprints and or assembly instructions as well as hardware call out requirements.
• Recruits, trains, and mentor employees.
• Ability to perform soldering tasks.
• Take on special projects as assigned.
• Wiring of electronics and complex assemblies and panels.
• Other duties as assigned.

Required Skills/Abilities:

• Team management and coaching.
• Exceptional negotiation and conflict resolution attributes.
• Ability to read and interpret documents such as blueprints, work instructions and procedure manuals.
• Ability to follow wire run diagrams for electro-mechanical system wiring.
• Strong mechanical and electrical aptitude abilities.
• Ability to perform troubleshooting on electro-mechanical assemblies.
• Use of manual and electronic torque tools, and other wrenches and tools.
• Use of wire cutters, crimping tools, and soldering.
• PCBA handling, integration, and connectivity.
• Ability to understand and follow proper ESD practices.
• Assembly of pneumatic and fluidic systems including pumps, tubing, and various interconnects.
• Strategic planning.
• Inspection tools such as vernier calipers and digital height gauges.
• Mechanical and electrical troubleshooting of assemblies.
• Use of microscopes for small assembly beneficial.
• Use of part cleaning technologies such as ultrasonic cleaning.
• Ability to communicate effectively through oral and written communications.
• Ability to work with others collaboratively.
• Attention to detail to understand and meet the requirements.
• Strong organizational skills.
• Process improvement.
• Demonstrated problem solving ability in a cross functional environment.
• Responsible for team tasks and time management.

Education and Experience:

• 5+ years in a regulated manufacturing environment, experience in an ISO 13485:2016, FDA Quality System Regulation (21 CFR 820) compliant manufacturing environment is preferred.
• Understanding of GDP (Good Documentation Practices) and GMP (Good Manufacturing Practices).
• Prior supervisory experience.
• Training experience.
• Cleanroom assembly experience is beneficial, preferably ISO Class 7.
• Experience with working to time standards.
• High School graduate.
• OSHA Safety certification, Certified in Production and Inventory Management (CPIM), and Certified Manufacturing Specialist (CMS) a plus.

Physical Requirements:

• Full range of motion for wrist, hand, and finger dexterity.
• Ability to frequently sit, stand, walk, stoop, kneel, and crouch.
• Ability to regularly lift/push/carry on average 30 pounds and at times up to 45 pounds.
• Ability to see up close and from a distance for assembly and evaluation.

This position requires 100% on-site attendance.