Senior Software Engineer

We are looking for an experienced Sr. Design Engineer- Medical Device. The Sr Design Engineer will be responsible for the design, development, verification, and validation of new and existing medical device portfolio. This role requires a strong technical background in mechanical engineering. The Sr. Design Engineer will play a pivotal role in driving innovation, ensuring product quality, and meeting regulatory requirements.

Responsibilities

• Leader of assigned product development projects.
• Cross-functional role including R&D, Quality Assurance, Manufacturing, and Regulatory Affairs to accomplish project goals and timelines.
• Execute detailed mechanical designs using SolidWorks and CAD models.
• Create detailed product drawings and component specifications.
• Manage design transfer activities from R&D to manufacturing.
• Manage and prioritize design upgrade, and improvements for existing products.
• Execute corrective actions and improvement proposals based on surgeon feedback.
• Ensure compliance with FDA regulations (e.g., 21 CFR Part 820) and ISO 13485 for medical devices.
• Support regulatory submissions.

Requirements:

• Minimum B.S. degree in Mechanical Engineering, Biomedical Engineering, or related field.
• Minimum 5 years of experience in engineering in the medical device industry.
• Deep background in medical device product development, including design, testing, and manufacturing processes.
• Experience in analytical processes (e.g., FEA, numerical modeling, Risk Analysis).
• Experience with implantable medical devices or surgical instrumentation.
• Familiarity with design for manufacturability (DFM) and design for assembly (DFA) principles.
• Excellent organizational and communication skills.
• Ability to prioritize tasks and manage multiple projects effectively.
• Hands-on, driven work ethic.

Pay: $75,000.00 - $90,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Work Location: In person