Mold Maker

Intepros; Tempe (AZ); On-site; USD 70,000 - 90,000; Full time

Job summary

IntePros is seeking a Mold Maker for a medical device manufacturing client in Tempe, AZ. You will be part of the Tooling Design Department, supporting mold and tooling design, fabrication, and repair to meet production needs.

The role requires 3+ years of experience, SolidWorks proficiency, and familiarity with cGMP/ISO/FDA standards. Collaboration with cross-functional teams and adherence to quality documentation are essential."

Qualifications

• Bachelor's degree in Mechanical or Manufacturing Engineering or equivalent experience.
• Minimum 3 years of relevant experience in molding/fabrication, preferably in medical device/manufacturing context.
• SolidWorks proficiency and experience with tooling design.

Responsibilities

• Maintain and support existing tooling and molds.
• Design experimental or production molds and tooling with minimal supervision.
• Coordinate tooling orders for manufacturing plants and ensure alignment with regulations.
• Collaborate with fabrication and elastomer facilities to verify and optimize tooling designs.
• Work with cross-functional teams to develop best practices and standards.
• Follow FDA, cGMP, ISO guidelines and ensure quality control and documentation.

Skills

SolidWorks

cGMP/ISO/FDA knowledge

English communication

Education

Bachelor's degree in Mechanical/Manufacturing Engineering

Tools

AutoCAD

Finite Element Analysis

Computational Fluid Dynamics

PDM Pro

Job description

IntePros is currently looking for a Mold Maker to join one of our growing medical device/manufacturing clients in Tempe, AZ. The Mold Maker will be a part of the the Tooling Design Department which is an essential component in Engineering and Operations. The team's objective is to continue the support in designing tools the manufacturing facilities require for production. In parallel, the team also provides innovative solutions and services to the tooling group and other departments within the company, where possible, to assist with meeting company goals and objectives. In this role, you will be part of a team that relies on effective teamwork and global collaboration in a fast pace and dynamic environment. This role may be responsible to set-up, operate, and monitor CNC and/or manual Milling Machines to provide operational support for the construction, assembly, and/or repair of molds, dies, and ancillary equipment.

Mold Maker Responsibilities

• Maintain and support existing tooling.
• Provide good centerline spacing lay out for experimental molds, commercial molds, MTD's and devices with little to no supervision.
• Able to design experimental molds, commercial molds, MTD's and devices with little to no supervision.
• Coordinate tooling orders for manufacturing plants.
• Good understanding of tools and processes within the individual’s region to support the client plants and other engineering departments with tooling issues, global tooling standardization questions and best practices
• Assume responsibility for various assigned projects to improve product quality and tooling designs.
• Collaborate with our fabrication shops and elastomer manufacturing facilities to verify, optimize and correct tooling designs and modifications.
• Work with cross-functional teams throughout all client locations to develop best practice standards.
• Maintain awareness of new technology trends, materials, and design/analytical software
• High understanding and aligned with company and department objectives.
• Self-sufficient and able to work with little to no supervision.
• Follow FDA, cGMP, ISO, and other applicable regulations.
• May load and unload raw materials and equipment and set up and operate a variety of machines according to instructions.
• May start and monitor machine operation to commence the production process, detect malfunctions/out-of-tolerance machining, and make any necessary adjustments to ensure product specifications are met throughout the process.
• May perform quality control, following appropriate reporting and documentation procedures.
• May transfer finished product, raw materials, tools, or equipment between work areas by using hand trucks or powered lift trucks (standing and/or sitting) and may perform routine maintenance tasks on machines as required.
• May use the ability to translate mechanical documents and engineering drawings into appropriate dimensions for production.
• May use the ability to correctly read common hand measuring tools such as outside micrometers, bore micrometers, dial indicators, etc. and inspect parts with appropriate measuring equipment to ensure results are within specification.
• May instruct fellow employees as needed and assist in the orientation and training of new employees when appropriate.
• Other duties as assigned.

Education

• Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, or equivalent experience required

Work Experience

• Minimum 3 years of relevant experience. Prior manufacturing experience in an industrial setting (pharmaceutical industry experience preferred). required
• Advanced in using SolidWorks. required

  Mold Maker Preferred Knowledge And Skills

  • Good understanding in machining and fabrication equipment and methods (e.g. milling, turning, grinding, eroding, etc.).
  • Familiar with cGMP, ISO, and FDA standards.
  • Familiar with AutoCAD, Finite Element Analysis, Computational Fluid Dynamics, and PDM Pro.
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Support and contribute in Lean Sigma programs and activities towards delivery of the set target
  • Able to comply with the company’s safety and quality policies at all times

  Travel Requirements

  • 5%: Up to 13 business days per year

  Physical Requirements

  • Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

  Additional Requirements

  • Must be able to negotiate and effectively resolve conflicts when required
  • Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
  • Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
  • Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
  • Read and interpret data, information and documents
  • Ability to quickly adapt to changes in a dynamic environment and must maintain the ability to work well with others in a variety of situations
  • Effective personal time management skills. Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Ability to make independent and sound judgments
  • Observe and interpret situations, analyze and solve problems
  • Must be able to speak English fluently