Process Engineer

Job Description

This is a “hands on” engineering position responsible for leading the development, installation, validation, ramp-up, and life cycle management of injection molds and molding solutions for medical device components.

Responsibilities:

• Serve as a Subject Matter Expert (SME) for injection molding systems.
• Develop a robust and repeatable process window based on scientific process engineering principles.
• Implement statistical process analysis on new and existing molds
• Document all injection molding system set-up requirements in Process Information Books and one-point lessons.
• Trouble shoot process related issues through a structured DOE
• Support the development of new injection molds by participating in mold design reviews and mold factory acceptance trials.
• Support the production ramp-up phase for new products and train appropriate personnel as needed.
• Lead Factory Acceptance Testing (FAT) at domestic and European mold vendors.
• Track process performance metrics and manage ramp-up action plan to achieve operational performance targets.
• Manage multiple programs with continuous collaboration with the project teams.
• Investigate and benchmark new tooling, peripherals, and molding technologies.
• Contribute to the development of specifications for the procurement of new injection molding machines and auxiliaries.
• Perform the initial set-up and establish the standards for injection molding systems.
• Implement safety, productivity, and yield improvements
• Provide continuous development of manufacturing techniques that will improve in-house capabilities.
• Participate with root cause investigations and corrective action implementation.
• Support lean and continuous improvement initiatives.
• Follow all safety procedures including the use of Personal Protective Equipment as required.
• Maintain good housekeeping of both office and factory workspaces.
• Work in ISO7 and ISO8 controlled environments with cGMP gowning requirements.

Preferred/Required Education/Skills:

• Engineering, technical degree or equivalent preferred
• RJG Master Molder I Certification strongly preferred
• Process Engineering experience working in high-volume plastic injection molding
• Industrial manufacturing experience working in high-volume injection molding
• Experience in the qualification of complex, tight tolerance injection molds (2-shot + Cube mold technologies)
• Must have clear and well organized oral and written communication
• Knowledge of statistical methods & statistical software (6 Sigma, SPC, DoE, Minitab)
• Excellent problem solving skills using DMAIC methodology
• Experience working in a cGMP / ISO 13485 compliant manufacturing environment
• Occasional travel up to 15 percent based on assignments; domestic and international
• Ability to lift 55lbs

Qualifications

Preferred/Required Education/Skills:

• Engineering, technical degree or equivalent preferred
• RJG Master Molder I Certification strongly preferred
• Process Engineering experience working in high-volume plastic injection molding
• Industrial manufacturing experience working in high-volume injection molding
• Experience in the qualification of complex, tight tolerance injection molds (2-shot + Cube mold technologies)
• Must have clear and well organized oral and written communication
• Knowledge of statistical methods & statistical software (6 Sigma, SPC, DoE, Minitab)
• Excellent problem solving skills using DMAIC methodology
• Experience working in a cGMP / ISO 13485 compliant manufacturing environment
• Occasional travel up to 15 percent based on assignments; domestic and international
• Ability to lift 55lbs

Additional Information

Why Join Nemera?

At Nemera, we prioritize patients when creating drug delivery devices, understanding that accurate dosing and ergonomics are crucial for treatment adherence. Joining Nemera means becoming part of a team that enjoys working together and consistently delivers on its commitments. We take pride in our work because it improves patients’ lives.

We look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs job in an international group, if you want to discover more about Nemera, please look at our website www.nemera.net

Know someone at Nemera? We have a Referral Program so, be sure to have them submit you as a referral prior to applying for this position!

For US Benefits, CLICK HERE.

Nemera is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other protected class indication. This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.