Sr Mechanical Engineer

5 days ago


Woburn, United States TalentBurst, an Inc 5000 company Full time

Role: Sr Mechanical Engineer

Location: Woburn, MA 01801 (on site at least 4 days a week)

Contract: 6+ months


Summary:

* The Contractor Mechanical Engineer will assist in updating component level manufacturing documentation, work on Design for Manufacturing improvements, and improve overall manufacturing in support of ISO-13485 certification and IVDR Class A products.

* The individual should have at 5+ years of engineering design experience and manufacturing support related to machined, sheet metal, injection molded components and cable assemblies used within electro-mechanical sub-assemblies.


Essential Responsibilities:

* The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity.

* Review and update mechanical drawings and specifications

* Apply sound engineering judgement to complete risk assessments

* Determine where and how to apply Critical to Quality (CTQ) inspection criteria

* Measure/inspect electromechanical components for form, fit, and function

* Perform robust root cause analysis of production issues

* Process Change Orders within an eQMS

* Communicate effectively both verbally and in writing


Non-Essential Responsibilities:

* In addition to the essential responsibilities listed above, the employee may be required to perform other non-essential functions.

* Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.


Qualifications:

* Bachelor's Degree in Mechanical Engineering

* 5+ years of mechanical or manufacturing engineering experience in a regulated industry; medical device experience is helpful

* Experience utilizing SolidWorks and PDM for design

* Knowledge of QSR and ISO regulations is a plus

* Good written and oral communication skills, including ability to communicate effectively at all levels of the organization

* Works well in a team, proactive, thrives in fast moving environment



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