Role Overview:

• We are seeking a Mechanical Engineer (E2 level) to design and develop hardware systems for innovative medical devices. The role involves component/system design using SolidWorks, creating design specifications, selecting appropriate materials/processes, and ensuring compliance with FDA and regulatory standards. You will collaborate with cross-functional teams, support testing/validation activities, and contribute to strategic initiatives for continuous improvement.

• Perform system and component design of capital equipment devices, including hardware and technology selection.
• Develop design specifications, bill of materials (BOM), and technical documentation.
• Support product definition team with feature selection and feasibility studies.
• Conduct design analyses using empirical and computational models to identify and mitigate risks.
• Collaborate with suppliers, vendors, and internal stakeholders to refine product requirements.
• Support bench testing, animal studies, clinical evaluations, and production activities.
• Contribute to design reviews and continuous improvement initiatives.
• Ensure compliance with FDA regulations, company policies, and quality standards.

• Bachelor’s degree in Mechanical Engineering or related field.
• 4+ years of relevant hardware design and development experience.
• Proficiency in 3D CAD (SolidWorks).
• Strong knowledge of metals (machining/forming) and plastics (molding/machining/forming).
• Excellent communication and collaboration skills.

• Familiarity with IEC 60601 standards.
• Experience in medical device design and development.
• Knowledge of electronics and system integration.
• Hands-on experience with fabrication tools (mills, lathes, etc.).
• Strong analytical, problem-solving, and statistical analysis skills.
• Ability to work in a cross-functional, fast-paced, and global environment.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)