Product Development Engineer (Medical Devices)
Location: Framingham, Massachusetts
Posted: December 19, 2016
Reference ID: 1566713392
We have an immediate need for a Product Development Engineer for a medical device company in Framingham, MA. Ideal candidates would be a hands Project Engineer with a strong background in end-to-end life cycle support. Both positions are long-term needs that have a high probability of going direct.
Please email your resume t Todd.Schecter@AdeccoNA.com for review
Responsible for product development projects associated with the electronic systems for ventricular assist devices.
These projects may include controller unit, rechargeable battery, external power sources, and monitoring equipment and communication systems.
Essential Job Functions
Work as part of a project engineering team, led by Product Development Principal Engineer(s), with Hardware Engineering, OEM Vendor(s), and Quality Assurance Engineering, through the design, development and verification phases for electronic systems for ventricular assist device projects.
Develop project documentation within the scope of Design Controls; maintain Design History File and design traceability documentation. Create models and 2-D drawing packages under direction of Senior or Principal Engineers, using SolidWorks.
Perform GD&T and tolerance stack analyses.
Assist Senior and Principal Engineers with generation of design input requirements, design specifications, design outputs and verification documentation.
Participate in Project and Technical Design Reviews.
Work with technical staff, Quality Assurance, and Clinical Affairs in the development of Risk Management process.
Liaison to suppliers in procurement of components, sub-assemblies and contract services.
Actively participate in the generation of IP.
BS degree in Mechanical Engineering or Biomedical Engineering.
3+ years in product development experience with medical devices
Must have demonstrated completion of development projects
Highly proficient in SolidWorks
Create mechanical drawings to ANSI Y14.5 Standard
Determine critical dimensions from Risk Management documentation.
Dimension drawings to critical dimensions and align with vendor capability and inspection requirements.
Good understanding of GD&T (Geometric Dimensioning and Tolerancing).
Knowledge of mechanical fabrication processes including Plastic Injection Molding and metal machining.
Tolerance Stack analysis.
Ability to meet program deliverables and timing, and thrive in fast-paced environment.
High organizational and multitasking abilities.
Understanding of electronics packaging.
SolidWorks and/or Pro Engineer, MS Project