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Systems Engineer in Boston, MA at APEX Systems

Date Posted: 2/12/2018

Job Snapshot

  • Employee Type:
    Contractor
  • Location:
    Boston, MA
  • Job Type:
    Other
  • Experience:
    Up to 2 year(s)
  • Date Posted:
    2/12/2018

Job Description

Job #:  821914

Seeking an engineer with a background in medical devices. Preferred experience includes Systems Engineering and experience with product development. Other desirable skillsets including robotics, research and development, testing, test methods, verification and validation, clinical experience, etc. For immediate consideration, please send your updated resume to zburrell@apexlifesciences.com

 

Must Haves:

  • Organized
  • Knowledge of requirements-based product development
  • Clear verbal and written communication skills

 

POSITION SUMMARY:

  • The Requirements Engineer will be responsible for supporting the development of a minimally invasive surgical platform for the R&D organization by reviewing, documenting, and managing product requirements for a complex, robotic surgical system.
  • The candidate will be responsible for ensuring the overall consistency, testability, and accuracy of requirements content, and the adherence to internal Quality System processes and applicable regulations.
  • The candidate should have a good understanding of Design Control for medical devices and product requirements development.
  • The candidate shall have excellent written and oral communication skills, attention to detail, strong organizational skills, and should be able to work in a multi-site team environment.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The Requirements Engineer is responsible for:

  • Assisting the System Architecture team, subsystem R&D teams, and Marketing in their development, prioritization, and release of product Requirements
  • Maintaining requirements content and traceability in the requirements development database.
  • Ensuring that all changes to requirements documentation are documented and traceable in accordance with Quality System and Good Documentation Practice procedures.
  • Reviewing proposed Requirements for consistency, accuracy, ambiguity, testability and adherence to Good Documentation Practices (GDP).
  • Review test methods and engineering reports to ensure that verification and validation appropriately tests Requirement intents
  • Assisting System Architecture team with generation of documents that support specification derivation and sourcing of Subsystem requirements
  • Interfacing with cross-functional teams to resolve requirement conflicts or gaps.

 

JOB QUALIFICATIONS:

  • Understanding of basic Systems Engineering and/or requirements-driven product development principles
  • Knowledge of principles and applications of biomechanics, mechatronics, and electrical, mechanical or software development.
  • Communicates effectively with cross-functional and multi-site teams.
  • Highly organized and attentive to detail

 

Other Beneficial Skills/Qualifications:

  • Understanding of medical device industry, clinical anatomy, and competitor products. Knowledge of other related disciplines including cross functional fields and market competition.
  • Awareness of clinical and regulatory pathways, IP and internal processes.

 

EDUCATION:

  • Minimum of B.S. (or equivalent) degree in Engineering, Math, Computer Science, or related field.

 

EXPERIENCE:

  • 0 - 2+ years of experience in medical device development, preferably with electro-mechanical, robotic, or software applications/products.
  • 0 - 2+ years of direct involvement with product requirements development and verification.

 

WORKING ENVIRONMENT/PHYSICAL ACTIVITIES:

  • Work usually performed in an office setting, laboratory, and/or surgical laboratory with frequent sitting, walking, standing, kneeling, crouching, crawling, balancing, stooping, and occasional climbing.
  • Oral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone or over frequent web-based meetings.
  • Light physical effort required by handling objects up to 20 pounds occasionally
  • and/or up to 10 pounds frequently.