Sr. Molding Process Engineer

IntePros is currently looking for a Sr. Molding Process Engineer to join one of our growing Medical Device/Manufacturing clients in Tempe, AZ. The Sr. Molding Process Engineer will support the process engineering/operations group by evaluating and implementing new equipment through validations and involvement in process improvement projects. Carry out special analytical investigations to generate critical technical information, making decisions concerning product improvement and overall quality. Implement, interpret, correlate, and communicate statistical studies performed on manufacturing processes. Through understanding of tooling / process interactions and development of process, provide all pertinent validations of both tooling and process. Interacts with Engineering / Customers on new projects or issues pertaining to the facility's processes. Write detailed technical reports on analytical data; provides periodic updates pertaining to assigned projects.

Sr. Molding Process Engineer Responsibilities:

• Lead the installation and validation of new equipment/process development through SAT/IQ/OQ/PQ
• Develop/write technical reports, protocols, change controls, issue reviews as required to defend or support decisions concerning material acceptability.
• Interacts with all departments pertaining to implementation of statistically established studies either for process improvements or establishment thereof.
• Ensure quality of all materials used in the process by developing and implementing effective reliable testing techniques.
• Ensure continued reliability of testing techniques by maintaining current knowledge of all technical and analytical information.
• Write technical reports as required to defend or support decisions concerning material acceptability.
• Establish and implement reliable procedures to ensure compliance with good manufacturing practices.
• Provide project leadership for materials / process related projects by coordinating the efforts of the various departmental disciplines for successful completion according to plan and budget.
• Support the efforts of production in materials related areas as a technical advisor.
• Reviews data using Minitab, for investigation of problems.
• Take appropriate action to ensure compliance with all safety, health and hazardous communication standards.
• Ensures that established policies, rules and regulations, and procedures are followed.
• Other duties as assigned.

• Education: Bachelor's in Engineering/Plastics. Industrial Experience will be considered in lieu of Degree with 8+ years' Injection Molding Engineering Experience
• Experience: 8-10 years of experience

• Minimum 5 years experience with Process Engineering required

• Complete working knowledge of all the molding processes in the plant and the associated tooling for each; including tooling design and manufacture.
• Demonstrative knowledge of variability, numerical reasoning and computer applications.
• Must have an in-depth knowledge of Statistical Process Control (SPC) and Design of experiments (DOE) and demonstrate use of same.
• Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
• Experience in writing and executing validation protocols and reports,
• 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 policy at all times
• Able to comply with the company's quality policy at all times.

• Manufacturing\Lean Six Sigma Certification-IASSC Lean Certification of any level Upon Hire preferred

• 10%: Up to 26 business days per year

• Light-Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects.

• Has superior analytical, organizational, leadership and technical skills
• Ability to assert technical solutions and standards
• Self-motivated, results- and solution-oriented personality
• Must have excellent written and verbal skills
• Excellent interpersonal skills: good team player and individual contributor as well
• Interpret data, read and write, effective communication, decision making, presentation skills
• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
• Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments. May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.