Mechanical/Manufacturing Engineer

Growing commercial stage medical device manufacturer with sophisticated diagnostic instrumentation that detects preclinical manifestations of a progressive disease that impacts nearly 200 million people worldwide. The early detection it provides spares a lifetime of diminished capacity.

The skilled engineer in this challenging role will provide mechanical engineering expertise to support the design, transfer and manufacture of electro-mechanical medical devices. He or she will be a key member of the product development team transitioning the product for effective scale up using best practice engineering concepts.

Responsibilities:

  • Initiate mechanical engineering activities to effectively design complex electro-mechanical medical devices and support the production environment.
  • Create and interpret SolidWorks CAD models to define component, product and specification needs.
  • Support the company’s Quality Assurance activities and policies and proactively ensures regulatory compliance (ISO and FDA).
  • Identify critical component design requirements and inspection plans, assist in developing manufacturing and assembly plans and implementation strategies to ensure design requirements are consistently met.
  • Evaluate mechanical and electromechanical systems and products, diagnoses product failure modes and performs root cause nonconformance analysis.
  • Actively participate in project teams representing the engineering department, ensuring project schedules and objectives are met.
  • Create and maintain in-process work instructions and test plans. Develop and execute process and product verifications and validations.
  • Work with the Quality team to ensure that all components, design, and products meet or exceed customer expectations with a high level of reliability and consistency.
  • Proactively identify assembly and production related issues and implement timely solutions related to product design and manufacturing and implement engineering design changes.
  • Analyze product design and establishing effective test plans and methods to assure product reliability.
  • Identify tooling, equipment and fixturing needs to create or improve manufacturing processes to ensure best product performance.
  • Design manufacturing fixtures and process equipment required to test and assemble the product.

Qualifications:

  • BS Mechanical, Manufacturing/Industrial or Electromechanical Engineering.
  • 4+ years mechanical or electro-mechanical design and/or manufacturing engineering experience in medical device capital equipment or other exacting, regulated industry.
  • Proficient SolidWorks 3D CAD.
  • Experience with IPC-J-STD-001 and/or IPC-A-610 a plus.
  • Self-starter and with the ability to work well in a start-up environment.

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