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
