Tooling Engineer I

CIVCO Medical Solutions is seeking a motivated and detail-oriented Tooling Engineer I to contribute to the design, development, and maintenance of tooling, equipment and fixtures used in the manufacturing of injection-molded and machined medical devices.

This position offers an exciting opportunity to learn and grow within a dynamic engineering team, directly impacting the production and quality of life-changing medical products.

The Tooling Engineer I will work closely with manufacturing engineers, quality assurance, and production teams to ensure efficient and reliable manufacturing processes.

Responsibilities:


* Assist in the design, development, and validation of new tooling, fixtures, and gauges for various manufacturing processes, including machining, molding, assembly, and packaging.


* Create and maintain detailed tooling drawings, specifications, and documentation using CAD software (e.g.

Creo).


* Collaborate with external vendors and suppliers in the fabrication and procurement of tooling components.


* Participate in the troubleshooting and resolution of tooling-related issues on the production floor to minimize downtime and ensure product quality.


* Support the implementation of tooling improvements and modifications to enhance efficiency, reduce costs, and improve safety.


* Assist in the development and execution of tooling validation protocols (IQ, OQ, PQ).


* Maintain accurate records of tooling inventory, maintenance schedules, and repair activities.


* Adhere to all company policies, procedures, and regulatory requirements, including those related to quality systems (e.g., ISO 13485, FDA regulations).


* Participate in cross-functional teams to support new product introductions and process improvements.


* Continuously seek opportunities to expand technical knowledge and skills related to tooling and manufacturing technologies.


* Perform other related duties as assigned.

Qualifications:


* Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a relevant discipline.

 


* 0-2 years of experience in a manufacturing environment, preferably within the medical device or a similarly regulated industry.


* Basic understanding of tooling design principles, materials, and manufacturing processes (e.g., machining, injection molding, inspection).


* Proficiency in CAD software (e.g., Creo) for creating and modifying drawings.


* Familiarity with GD&T (Geometric Dimensioning and Tolerancing) principles.


* Strong problem-solving and analytical skills with the ability to troubleshoot technical issues.


* Excellent communication, interpersonal, and teamwork skills.


* Ability to work independently and manage multiple tasks effectively.

 


* A strong commitment to quality and attention to detail.


* Knowledge of medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485) is a plus.


* Experience w...