Mechanical Engineer

Key Responsibilities:

• Lead end-to-end new product development (NPD) and manufacturing transfer for medical devices.
• Design LSO products and tooling hands-on using SolidWorks.
• Act as the main point of contact between internal teams and customers to align goals and timelines.
• Create and manage project plans, budgets, schedules, and risk assessments.
• Coordinate across R&D, Quality, Regulatory, Manufacturing, Marketing, and Supply Chain.
• Launch new production lines, including writing procedures, clearing lines, and training staff.
• Train and support teams on manufacturing and quality systems (FDA QSR, ISO 13485).
• Ensure accurate and compliant completion of work orders and production documents.
• Assist in validation efforts: IQ/OQ/PQ/PPQ, TMV, and process characterization.
• Promote process, quality, and documentation improvements.

Qualifications:

• Bachelor's in Mechanical, Biomedical, Materials Engineering, or similar field.
• 4+ years in regulated medical device development or manufacturing.
• Demonstrated experience managing complex projects or programs.
• Proficient in SolidWorks and related design tools.
• Strong skills in documentation, organization, and communication.
• Familiar with FDA regulations, ISO 13485, and GMP standards.