Project Engineer

Mansfield, Massachusetts
 

 

PRIMARY FUNCTIONS AND RESPONSIBILITIES:

  • Under very limited guidance, will perform highly complex engineering duties associated with the development of implant and instrument systems

  • Manages research & development programs that could involve multiple interfaces internal and external to the company

  • Takes a leadership role in orienting and mentoring R&D team members.

  • Oversees project assignments to team members within functional group and ensures technical soundness of work, compliance to company standards and best practices, and delivery of project tasks (of functional team members) within the agreed upon time frame.

  • Responds to R&D team members concerns and develops methods for continuously improving productivity and efficiency within the group.

  • Interfaces with surgeons to develop user requirements and evaluate designs

  • Interfaces with Manufacturing Engineering, Purchasing, and various vendors to manufacture prototypes and finished devices

  • Determines appropriate technical strategy and detailed plan needed to attain project objectives and communicates comprehensive plan to Program Lead.

  • Develops and Manages R&D functional group schedules, resources and budgets.

  • Reviews and critiques (as appropriate) task and resource duration estimates within functional group and works with Program Lead to establish the development of a sound project schedule.

  • Must be an excellent communicator, keeping Program Lead and R&D Director “in the know”, and be able to alert both of impending issues and their expected solutions.

  • Must be able to proactively identify R&D issues that may affect program delivery dates well in advance of any potential impact on the program and creatively work with Program Lead to figure out how to keep program on track no matter what (without sacrificing values).

  • Provides feedback to Program Lead on attainment of design inputs as soon as design feasibility assessed (meets target, meets limit, or does not meet input).

  • Provides written summary of specific technical activities that support verification that outputs meet inputs and that validation of finished good device meets user needs for inclusion in design review minutes and DHF. 

  • Acts as point person for any complaint analysis and / or evaluation of the merit of new products or product features.

  • Reviews and approve both implant and instrument designs and drawings

  • Provides R&D technical input for all Design Control processes for a given program including Project Planning, FMEA’s, Design Reviews, DHF content, etc.

  • Researches, analyzes and creates intellectual property

EXPERIENCE & SKILL REQUIREMENTS:  

  • Should have experience managing development and/or research programs

  • Should have experience managing people

  • Must have a working understanding of FDA QSR and ISO-13485 principles

  • Should be a creative thinker and a good problem solver

  • Should have significant medical device development experience

  • Should be a self motivated individual that is able to work with minimal supervision

  • Ability to conduct theoretical analysis or develop mechanical test protocols and manage testing

  • Working knowledge of 3D CAD systems (SolidWorks preferred)

  • Working knowledge of manufacturing processes and capabilities 

EDUCATIONAL REQUIREMENTS:  

  • B.S. Mechanical or Biomedical Engineering
  • and/or M.S. Mechanical or Biomedical Engineering

 


Interested Individuals Should contact:  

Meggan Hope
Xavier Associates
 

mhope@xavierassociates.com