Principal Mechanical Engineer

Our client is seeking a dynamic individual to drive the development of cutting-edge medical devices. This role involves leading projects from concept through to manufacturing, ensuring compliance with regulatory standards, and fostering an innovative engineering environment.

• Lead technical aspects of medical device systems, collaborating with cross-functional engineering teams.
• Manage project timelines and guide teams to ensure on-schedule delivery.
• Conduct feasibility studies and provide engineering analysis to support development projects.
• Innovate and test new concepts, aligning with clinical and business needs.
• Maintain comprehensive documentation throughout the design process.
• Develop and validate test methods, ensuring product design meets quality standards.
• Oversee prototype manufacturing, including BOM generation and process development.
• Operate and train others on critical lab equipment.

• Bachelor's Degree in ME, IE, EE, or related field.
• 10 years in medical device design and manufacturing.
• Proficient in Design Control, process verification, and validation.
• Solidworks or CAD expertise.
• Understanding of ISO Quality Systems and FDA regulations.
• Experience with manufacturing processes like injection molding and die casting.

• Six Sigma or SPC knowledge; Green or Black Belt certification.
• Familiarity with project management tools.

At Talent Wave Associates, we connect outstanding talent with exceptional opportunities. We're proud to be an Equal Opportunity Employer and are committed to fostering an inclusive, people-first recruiting experience. Ready to ride the wave of opportunity? Apply today!

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