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R&D Engineer - Medical Device Industry

Connexion Systems & Engineering, Inc.
Beverly, MA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Job Title: R&D Engineer II
Location: Beverly, MA
Duration: Permanent
 

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 products being able to make decisions that will have direct impact on the quality of our products.

 

RESPONSIBILITIES:

  • Research and analyze data such as customer requirements, standards, and industry trends to determine feasibility of design or application. 
  • Interface with health care professionals to define customer requirements.
  • Provide alternative product designs and evaluate them using various analytical tools like tolerance analysis, design for manufacturability and assembly, etc.
  • Follow Design Controls and GMP regulations.
  • Create and maintain Design History File and traceability among its different elements like Requirements, Risk, V&V documents.
  • Understand IEC, ISO standards that apply to company products 
  • Create drawings and layouts of new or improved designs for prototype fabrication. 
  • Effectively communicate information to co-workers, customers, and suppliers to facilitate project goals.
  • Perform and report on evaluation testing, verification, and validation in accordance with ISO, FDA, and corporate guidelines.
  • 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.
  • 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.

 

QUALIFICATIONS:

  • BS degree in engineering or equivalent experience.
  • Mechanical Engineering background with working knowledge of electronics/software.
  • Minimum of 5+ years of related experience in the medical device industry
  • 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.
  • Proficient in the use of SolidWorks/PDM Vault
  • Must have demonstrated ability to work as part of a team.
  • Demonstrated complex problem-solving skills using structured problem-solving methodologies.
  • Must be able to work independently and be self-motivated.
  • Strong Program/Project management skills needed.

Connexion Systems & Engineering, Inc.

Address

Beverly, MA
USA