Electrical Engineer

Primary Talent Partners has a 12 - month contract opening for an Electrical Engineer with a large medical device client of ours in Billerica, MA.
JOB DESCRIPTION
Top 3 skills required:

• Lead the design, development, and implementation of manufacturing line transfers.
  
• Debug complex electrical systems within a manufacturing environment leveraging manufacturing tools, processes, or systems as necessary.
  
• Supports the lead engineer with the overall short-term and long-term design strategy.
  

Responsibilities:
Areas of responsibilities will include electrical system design, design requirements, test requirements, test procedures, and manufacturing.
Candidates must be able to understand design inputs and concepts, interpret detailed electrical specifications, generate, and review design documentation, test specifications and test reports in compliance with design control procedures used within the medical device industry.
Candidates must also be willing to work in a fast-paced, multi-tasking, team environment.
The candidate must have the ability to work well with a variety of individuals ranging from the various engineering disciplines (mechanical, electrical, and software) to marketing, clinical, reliability, regulatory and operations.
Other duties may be assigned:

• Lead the design, development, and implementation of manufacturing line transfers.
  
• Proven ability to debug complex electrical systems within a manufacturing environment leveraging manufacturing tools, processes, or systems as necessary.
  
• Supports the lead engineer with the overall short-term and long-term design strategy.
  
• Accountable for supporting day-to-day requests from operations.
  
• Leads and conducts root cause investigations for manufacturing failures with cross-functional teams.
  
• Provide technical assistance to other functional departments such as Quality, Reliability, and Manufacturing
  
• Work with other engineers and technicians to execute experimental designs and analysis.
  
• Initiate and execute change management to implement design changes or resolve part obsolescence
  
• Ensure execution of detailed engineering analyses & documentation to support design development and support process transfer.
  
• Assume responsibility as subject matter expert to represent organization as primary contact for specific projects and initiatives.
  
• Apply and interpret characterization DOE models to establish optimal material and process input set points.
  
• Communicate effectively with cross-functional teams across multiple sites to ensure alignment of bigger picture.
  
• Manage multiple high priority design requests.
  
• Utilize technical skills associated with Six Sigma, Lean, DRM/DFSS and other appropriate continuous improvement techniques.
  
• Work independently, in consultation with Engineering Management
  

Education/Minimum Requirements:

• Bachelor’s degree required – Electrical Engineering
  
• Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
  
• Strong knowledge of schematic design and layout using CAD tools for PCB design such as OrCAD
  
• Strong knowledge of formal PCBA documentation (schematics, PCB fabrication drawing, PCB assembly)
  
• Strong experience in technical specification, process and report writing
  
• Must be able to review the work of other engineers
  
• Mastery of basic laboratory instruments and tools (e.g., DMM, oscilloscope, logic analyzer, spectrum analyzer)
  

Nice to Have:

• Medical Device Industry experience
  
• Capital Equipment design experience
  
• Experience in application of DRM methodology for product design
  
• Experience with statistical analysis of data (Ex. Minitab, JMP, MATLAB, etc.)
  
• Experience with technical documentation (Ex. laboratory notebooks, publications, engineering reports, specifications,
• IQ/OQ/PQ’s, Standard Operating Procedures, test protocols, etc.)
  
• Direct experience in characterization, design of experiments and data analysis methodologies (T-test, ANOVA and significance testing at a minimum)
  
• Knowledge of medical device product development cycle
  
• Knowledge of regulatory submissions and guidance for medical devices
  
• Related experience providing supporting data to governing bodies (FDA, cFDA, PMDA, LNE GMED, etc.)
  
• Demonstrated ability to manage multiple tasks and projects
  
• Ability to influence key stakeholders for alignment and drive decision-making
  
• Self-driven, ambitious, accountable, and detail-oriented
  
• Demonstrated ability to work independently and within a team-based environment
  
• Experience with SolidWorks is a plus
  

• 5 or more years in one or more of the following: RF ablation generator design, medical device design, embedded microcontroller/microprocessor system design
  
• Strong knowledge of analog and digital design
  
• Specific knowledge of Domestic and International standards for Ablation Generators
  
• Knowledge of engineering and manufacturing test equipment design and LabView is a plus
  
• Experience working with vendors and contract manufacturers for PCB fabrication and assembly is a plus
  
• Experience writing embedded firmware in assembly and/or C/C++ is a plus
  
• Knowledge and experience with electromagnetic compatibility testing
  
• Knowledge and experience with electrical safety testing in accordance with IEC 60601
  
• Knowledge and experience with hi-pot testing

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
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