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Research and Development Engineer

Tewksbury, MA

Design, develop and update cardiac implants and delivery catheters for treatment of cardiac valve insufficiency. Position includes support of multiple development projects or primary management of a development project of moderate scope with guidance from management as needed. As a Project Leader, the engineer would also serve as the primary technical contributor through manufacturing onload.

Primary Responsibilities

  • Develop catheters, handles, implants and other medical devices within the EN 13485 compliant design control process
  • If assigned a device project, manage and maintain primary leadership of assigned project through the design control process from concept through manufacturing transfer to product commercialization
  • Create and manage timelines for projects through full range of assigned responsibility.
  • Proactively communicate program progress, risks and recommendations to management as appropriate
  • Develop and document thorough and accurate specifications for devices, components and materials
  • Develop test methods, create written procedures and as needed perform product testing
  • Develop robust manufacturing processes and create written procedures
  • Perform or oversee conceptualization, design, documentation and fabrication of fixturing for test and assembly
  • Develop, build and iterate product prototypes
  • Provide routine verbal updates to management and written reports of work
  • Develop engineering experiments with guidance as needed, execute, analyze and document to guide product and process development
  • Propose vendors or develop assigned vendors and serve as primary interface within all phases of product development including prototyping, development and initial production
  • Operate within Mitralign procedures and industry standards for product development and manufacture
  • Maintain laboratory notebooks to document work activities
  • Participate in clinical activities including observing medical procedures and interfacing with clinicians
  • Participate in animal studies related to development work
  • Participate in patent related activities related to development work
  • Participate in production build and QC inspections activities as needed
  • In addition to the essential functions listed above, other responsibilities and key result areas as assigned

Supervisory Responsibilities

Engineering technician or intern.

Education Requirements

BS degree in engineering (Biomedical, plastics, mechanical or similar)

Experience

  • Minimum of 3 years of hands-on experience in an engineering position, preferably in the medical device field
  • Experience with management of a project timeline
  • CAD experience recommended (preferably SolidWorks)

Knowledge

  • Good mechanical aptitude
  • Practical understanding of general materials properties, stress/strain, kinematics/dynamics
  • Understanding of polymeric materials and metals and their properties
  • Understanding of primary and secondary processes commonly used in catheter assembly, including injection molding, extrusion, melt and adhesive bonding and machining
  • Must have working knowledge of ISO 13485 and FDA Quality System Regulations

Skills

  • Team player possessing a high level of ethics and professional integrity
  • Ability to produce prototypes and test units in an engineering lab environment
  • Ability and personality to manage projects in a fast-paced small company environment
  • Ability to learn and work within regulatory requirements associated with medical technologies
  • Excellent verbal & written communication skills applied within the company and with vendors and consultants
  • Must be able to work independently and be self-motivated

Physical Demands and Conditions Requirements

  • General office and engineering lab environment.

Equipment Used

  • General office equipment.
  • Hand tools and machine tools

Job Type

Full Time

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Mitralign, Inc.

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