Senior Mechanical Engineer

Job Title: Senior Mechanical Engineer Job Type: Full Time (40 hours a week)

Department: Engineering Salary Rate: $100,000 - $150,000 annual

Duration: Permanent

The Senior Mechanical Engineer supports the design, development, verification, validation, and optimization of mechanical components and assemblies for medical devices throughout the product lifecycle. Responsibilities include creating and maintaining detailed CAD models and engineering drawings, performing engineering analyses, leading prototype builds, planning and executing characterization and verification testing for new and existing products.

The role involves collaborating with cross-functional teams including Quality, Regulatory, Manufacturing, Clinical, and Program Management.

• Apply mechanical engineering principles to the development, evaluation, and improvement of medical device components and assemblies.
• Proficiency in medical device design, including mechanisms, material selection, and tolerance analysis for complex assemblies.
• Hands-on experience with Solid Works for 3D modeling and detailed drawings.
• Background in Research and Development (R&D), including prototyping, testing, data analysis, and iterative design improvement.
• Experience with design for manufacturability (DFM), design for assembly (DFA) for molded polymer materials.
• Develop and maintain risk management files (FMEA, hazard analysis) per ISO 14971.
• Project Management skills to organize tasks, track milestones, and collaborate effectively with cross-functional teams.
• Background with medical device standards, quality systems, and regulatory requirements (e.g., ISO 13485, FDA).
• Strong analytical, problem-solving, and communication skills, with the ability to document work clearly and work independently and in teams.

• Bachelor's degree in mechanical engineering or a related technical field.
• 5+ years of medical device product development experience.
• Proficiency with Solid Works and mechanical design of complex assemblies.
• Experience with design verification, statistical methods, and test method development.
• Experience with risk management, technical documentation, and product testing.

• Experience with Class II or Class III medical devices.
• Strong knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and design controls.
• Experience supporting FDA 510(k), De Novo, or international regulatory submissions.
• Strong technical writing skills;
  Solid Works, MS Office, and statistical/analysis tools.
• Detail-oriented with strong organizational, communication, and time management skills.
• Collaborative and solutions-oriented; able to work cross-functionally and influence without authority.