Senior Mechanical Engineer

3 days ago

Raleigh, North Carolina, United States Merz North America Full time
Job Summary

Merz North America is seeking a highly skilled Principal Mechanical Engineer to join our Advanced Development team. As a key member of our team, you will be responsible for developing new products, redesigning existing products, and performing research and testing on product concepts related to medical devices.

Key Responsibilities
  • Technical Leadership: Provide technical leadership of system features and functions as applicable to a medical device, requiring collaboration and leading of other engineering groups.
  • Mechanical Engineering: Take leadership of projects in development, managing all team members assigned to projects to keep them moving forward on schedule. Provide engineering analysis, feasibility reports, and studies to assist advanced development projects.
  • Innovation: Develop, design, and test innovative concepts and solutions that align with the needs of the clinic, patient, and business. Collaborate with the engineering and marketing department on product feasibility.
  • Documentation: Maintain accurate documentation throughout the design process per GDP and GMP. Write product requirements and specifications to support feature development and the product roadmap.
  • Test Methods: Prove product design by developing test plans, adjusting design, running performance calculations, maintaining quality standards, and approving prototypes. Validate the test tool or setup is usually required.
  • Prototype Manufacturing: Lead engineering prototype builds, including generating BOMs, ordering parts and materials, and training lab technicians. Work closely with pilot manufacturing line and operations group to develop a device build process.
Requirements
  • Education: Bachelor's Degree in ME, IE, or EE or other relevant Engineering discipline.
  • Experience: 10+ years of related design and manufacturing experience in the medical device and/or component development industry.
  • Design Control: Experience in design and process verification and validation, including IQ, OQ, and PQ.
  • Manufacturing and Assembly: Knowledge of injection molding, die casting, metal stamping, and/or machining, including fixtures, gauges, and tooling experience.
Preferred Qualifications
  • Project Management: Familiarity with project management methods and tools.
  • Quality System: Understanding and application of ISO Quality System requirements and FDA regulations for medical device manufacturing.

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