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NovintiX Inc.

TECHNICAL MANAGER/MECHANICAL ENGINEER

Pay: Not specified

Posted: 1 day ago

Location: Exton, PA (Onsite)

Last Updated: 6 hours ago

Hours: Full-Time

Expires: 10/16/2026

Job Description

TECHNICAL MANAGER/MECHANICAL ENGINEER

Exton, PA

04 Sep 2026

22908626

Summary

Exton, PA

In-Person

Competitive Salary

5 Years Experience

Bachelor's degree

No Commission

40.00 hours per week / Day Shift / Full-Time

Description

TECHNICAL MANAGER/MECHANICAL ENGINEER

(Exton, PA): With the use of mechanical engineering analysis and techniques, provide technical direction for EUDAMED implementation and maintenance; oversee UDI and mechanical data collection, validation, QMS retention, and database readiness; collaborate cross-functionally to ensure complete, traceable, and audit-ready submissions aligned with EU MDR, project timelines, regulatory expectations, and internal quality standards. Bachelors (or foreign equiv. deg.) in Mech Eng, Ind. Eng. or rel. + 5 yrs of prog. exp. in EU MDR Regulatory Compliance, EUDAMED Submissions, UDI/device/actor registrations, technical doc. req./SSCP Lifecycle, verification/validation, risk management, engineering change controls, ISO 13485, 14971, 15223 compliance, Windchill PLM for document control/chang management. Travel to various unanticipated domestic US client sites.

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NovintiX Inc. 801 Springdale Drive, Suite 100-X, Exton, PA 19341. Additional Details How To Identify Potential Job Scams