Senior NPI Engineer

United States·CarmelRegular Full-Timesenior

OtherEngineer

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Quick Summary

Key Responsibilities

Leads efforts to support production needs by working closely with management, ensuring efficient and effective operations. Oversee and conduct time studies, process flow analyses,

Requirements Summary

Expertise in primary manufacturing processes, fixture design, and tooling development, with a strong track record of optimizing production processes.

Technical Tools

OtherEngineer

Responsibilities

~1 min read

→Expertise in primary manufacturing processes, fixture design, and tooling development, with a strong track record of optimizing production processes.
→Extensive experience in supporting and improving a production environment, with a deep understanding of the operational requirements.
→Advanced proficiency in SolidWorks CAD software for designing, modeling, and creating detailed technical drawings and simulations.
→Proficient in operating and troubleshooting 3D Printing equipment and software.
→Advanced proficiency with Microsoft Office applications.
→Advanced proficiency with industrial engineering practices, including time studies, lean manufacturing techniques, and continuous improvement methodologies (LEAN/Six Sigma).
→Strong ability to create, review, and update SWI’s, SOP’s, CC’s, and visual aids.
→Strong ability to perform Non-Conformance investigations and CAPA root cause analysis.
→Strong familiarity with FDA regulations, ISO 13485 standards, and other quality control practices relevant to medical device manufacturing.
→Expertise with ERP systems and job traveler execution.
→Strong analytical and problem-solving skills, with the ability to tackle complex engineering challenges.
→Proven leadership in establishing and maintaining effective working relationships across teams and departments.
→Demonstrated ability to work independently with a strong sense of urgency, and effectively under pressure.
→Excellent written and oral communication skills.
→Ability to stand for prolonged periods of time.
→Ability to lift a minimum of 40 lbs.

Nice to Have

~1 min read

High School Diploma, GED or equivalent required.
Bachelor’s degree in Manufacturing Engineering, Industrial Engineering, Mechanical Engineering, or related field required.
5 years of experience in manufacturing engineering role within the medical device industry preferred.