Mechanical Engineer – R&D Job

Mechanical Engineer – R&D is needed to perform the following duties:

· Support DHF remediation activities, including updates to Design Inputs, Design Outputs, Verification, Validation, and Risk Management documentation.

· Perform gap analyses to identify discrepancies in requirements, verification evidence, and risk documentation.

· Execute product design, fixture design, and engineering development activities for new product development, sustaining engineering, and design changes

· Conduct and support TMV, Gage R&R studies, DOE, and DFMEA activities

· Develop and execute Design Verification and Validation (V&V) plans, protocols, and reports.

· Apply statistical methodologies, including DOE and ANOVA, to support process optimization and validation

· Evaluate and approve change requests related to product design, manufacturing processes, validation, and verification

· Support CAPA, NCR, complaint investigations, and root cause analysis.

· Participate in design and phase reviews to ensure compliance with regulatory standards and QMS requirements.

· Collaborate with cross-functional teams (R&D, Quality, Regulatory, Manufacturing) to support DHF remediation and continuous improvement.

Bachelor's Degree is required in Mechanical Engineering.

Health/Dental Benefits, Relocation Assistance, Offers Sponsorship for U.S. Visa

https://ndgcs.com/