Mechanical Engineer – R&D

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.