Sr. Engineer - R&D

AngioDynamics   •  

Marlborough, MA

Industry: Healthcare

  •  

8 - 10 years

Posted 37 days ago

Job Description

This position is responsible for leading the technical aspects of design and development of new medical device/equipment products from initial concept stage through to release and includes evaluating designs through modeling and testing.

  • Develops new technology, products, materials, processes, or equipment with minimal supervision. Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects.
  • Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.
  • Innovate, design, develop, optimize and implement processes, procedures, tooling and equipment for new products with specific emphasis on design for manufacturability.
  • Consistently generates innovative and unique solutions to market needs and submits idea disclosures. Work is expected to result in the development of new or refined products, processes or equipment.
  • Successfully completes complex engineering work in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
  • Use fundamental PD/DFM tools to reduce variation and achieve capable processes with high production yields where required.
  • Perform process optimization through DOEs, DCMs and process capability studies, as required
  • Selects techniques to solve complex problems and make sound design recommendations.
  • Summarizes, analyzes, and draws conclusions from complex test results.
  • Designs and prepares complex reports to communicate results to technical community.
  • Designs and coordinates complex engineering tests and experiments.
  • Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
  • Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.
  • Interfaces with Physicians/Cath Lab personnel to obtain feedback on concepts and performance of new devices.
  • Translates customer needs into product requirements and design specifications.
  • Responsible for engineering documentation
  • Works cooperatively with quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success and identify product performance requirements.
  • May train and/or provide work direction to technicians and entry-level engineers.
  • Demonstrates PDP/TPD system knowledge through delivery of high quality and high impact deliverables
  • Ensure adequate engineering studies, design verifications, and process validations are conducted such that well developed products are introduced into manufacturing.
  • Write, execute and review validation protocols and reports where appropriate.
  • Ensure documentation is completed to meet quality system requirements.
  • Conduct test method development as required by project teams.
  • Stay current with and ensure appropriate compliance with SOP's on all projects.
  • Provide timely responses to the Corrective Action/Preventive Action (CAPA) program as required.
  • Provide support as required to safety, ISO, FDA, corporate and internal audits.
  • May perform other duties as assigned

Regulatory Responsibilities

  • Manages in order to ensure compliance with all relevant regulatory/legal requirements

QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES

  • Individual Contributor - Build Quality into all aspects of their work by maintaining compliance to all quality requirements

Requisition Number

2544BR

Type of Position

Fulltime-Regular

Education & Experience

  • Bachelor's Level of Degree in the Engineering/Technical field of study
  • 8 years of demonstrated experience in Engineering or related field
  • 5 years of demonatrated experience with a Masters degree, or 3 years of experience with a PhD.
  • Experience in the medical device industry preferred

Skills/Knowledge

  • Prior experience with SolidWorks and Minitab software a plus
  • Proven statistical analysis on product and process capabilities
  • Proficient in the following computer software applications: MS Office - Outlook, Word, and Excel
  • Exceptional interpersonal skills.
  • Strong organizational skills.
  • Strong communication skills (written and verbal).
  • Ability to effectively communicate both internally and externally.
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence.