Mechanical Engineer

Overview

This role is for a Mechanical Engineer working on product development in a regulated environment. The position follows a hybrid schedule with 3 days on-site and 2 days remote each week.

Work Arrangement

• Hybrid model: 3 days in the office and 2 days working remotely.

Required Qualifications

• A bachelor’s degree in Mechanical Engineering is mandatory.
• At least 3 years of hands-on mechanical engineering experience within a product development setting.
• Practical exposure to the full Product Development Lifecycle (PDLM).
• Experience conducting Design Failure Mode and Effects Analysis (DFMEA).
• Background supporting design verification and validation efforts.
• Strong capability in technical documentation and engineering change control.

Preferred Qualifications

• Experience in the medical device industry is highly desirable.
• Prior work in FDA-regulated or similarly controlled environments is a plus.
• Familiarity with Creo for mechanical design and documentation is preferred.
• Working knowledge of SAP, especially for engineering documents and document handling, is valued.
• Exposure to Windchill would be an added advantage.

Key Responsibilities

• Contribute to DSx product development work across the entire product lifecycle.
• Facilitate and take part in DFMEA sessions and broader risk management activities.
• Plan, carry out, and record verification and validation testing.
• Prepare and update technical documents in line with quality and regulatory standards.
• Work closely with engineering, quality, regulatory, and manufacturing stakeholders.
• Investigate technical problems and support root-cause analysis.
• Assist with design reviews and continuous improvement efforts.

Additional Information

This position is based in Queens County, NY. The role is full-time and remote/hybrid in nature. No salary figure, number of openings, or start date was provided.