R&D Engineer II

At Microline, we are on a mission to improve the quality of life for everyone. To do that, we seek the best talent to expand and improve our team of dedicated, innovative employees.

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SUMMARY: Develops and completes designs for minimally invasive surgical instruments. Initiates, Plans, Directs Execution and brings to conclusion projects in the R&D portfolio. Leads design reviews with engineering, operations, and other stakeholders to reconcile objectives. Analyzes complex problems independently and initiates appropriate corrective actions. This position requires a deep understanding of Microline's products being able to make decisions that will have direct impact on the quality of our products.

ESSENTIAL FUNCTIONS: The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.

  1. Research and analyze data such as customer requirements, standards and industry trends to determine feasibility of design or application. 
  2. Interface with health care professionals to define customer requirements.
  3. Provide alternative product designs and evaluate them using various analytical tools like tolerance analysis, design for manufacturability and assembly, etc.
  4. Follow Design Controls and GMP regulations.
  5. Create and maintain Design History File and traceability among its different elements like Requirements, Risk, V&V documents.
  6. Understand IEC, ISO standards that apply to Microline's products 
  7. Create drawings and layouts of new or improved designs for prototype fabrication. 
  8. Effectively communicate information to co-workers, customers and suppliers in order to facilitate project goals.
  9. Perform and report on evaluation testing, verification and validation in accordance with ISO, FDA and corporate guidelines.
  10. Serve as project team leader throughout the new product development process; identify critical technical challenges, define schedules, assign tasks and quantify progress against project goals.
  11. Accurately predict the time required for project tasks; help assure the scheduled time is met or improved to meet company objectives. Timely communicate risks or issues that may affect the project quality, cost or schedule.

NON-ESSENTIAL FUNCTIONS: In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job related duties requested by their supervisor.


Qualifications

  1. BS degree in engineering or equivalent experience.
  2. Mechanical Engineering background with working knowledge of electronics / software.
  3. Minimum of 5+ years of related experience in the medical device industry
  4. Strong written and verbal communication skills for the purpose of technical/mechanical comprehension. Must be able to effectively communicate with medical professionals, outside contractors, customers and vendors.
  5. Proficient in the use of Solidworks / PDM Vault
  6. Must have demonstrated ability to work as part of a team.
  7. Demonstrated complex problem-solving skills using structured problem solving methodologies.
  8. Must be able to work independently and be self-motivated.
  9. Strong Program/Project management skills needed.



REASONABLE ACCOMMODATION: Microline Surgical is committed to the spirit and letter of the Americans with Disabilities Act and, as required by law, will reasonably accommodate otherwise qualified individuals.

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