Urgent Hiring for the Role : Electrical Engineer

Hello, this is Kiran from Intellect Inc. One of our Medical clients is hiring for the Electrical Engineer I. If you are interested then please share me your Updated Resume to my mail kiran.o@intellectt.com or you can reach me at (732)-398-6563.

Role: Electrical Engineer I

Location: Alameda, CA - 94502

Duration: 12 Months on W2 (Possible extension)

Shift Timings: 8 am to 5 pm

100% Onsite role.

Open to National Search (Relocation at open expense).

Summary

Works independently (or in a lead role) on qualifying alternate electronic and mechanical components for medical products. Exercises independent judgment in reviewing technical specification sheets for alternate parts recommended by Corporate or TPMs, creating change impact documentation with technical assessment to provide reason and justification to support change, working closely with R&D to ensure technical assessment are comprehensive and accurate, and leading reviews of the documentation with cross-functional team consists of Regulatory, Quality Assurance, R&D, Operations, and Global Sourcing, Develops networks involving cross functional/cross departmental groups as well as communication to senior management.

Skills Looking For

• Component Engineer; senior level role.
• Lead role that works independently in qualifying alternate electronic and mechanical components for medical products.
• Will use independent judgment to review technical specification sheets based on recommendations and qualify alternate electronic and mechanical components based on recommendations.
• Prepare a change document in the system providing a technical assessment of why alternate products could be used with justifications supporting the change.
• Leading the review of the document they prepared with cross-functional teams such as Quality Assurance, Regulatory, R&D, and Operations.
• Good knowledge of general Engineering principles
• Experience and knowledge of cGMP, FDA and ISO13485.
• Medical Device regulatory experience required. No other regulatory experience will be considered.
• Med device exp required.
• Excellent written and verbal communication skills
• Extensive understanding of processes used in the design and manufacturing of medical devices, particularly handheld devices
• Day to Day: Looking for alternate components, reviewing specification sheets, preparing documentation explaining why this component needs to be replaced and how the new product is more feasible and the best choice.
  
  

DUTIES

• Review technical specification sheets based on recommendation and qualify alternate electronic and mechanical components based on recommendations.
• Coordinate and lead the utilization internal/external resources to achieve project goals.
• Understand the business needs of the company and have a thorough understanding of customer
• Understand the business needs of the company and have a thorough understanding of customer and clinical needs as they relate to projects.
• Lead and/or participate on cross-functional teams to support organizational goals.
• Serve as subject matter expert (SME) or independent technical expert (ITE) on a project's technical matters; may interface with senior management, external firms or agencies; may coordinate technical matters between organizations.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Other tasks and duties as assigned.
• Understand and comply with applicable EHS policies, procedures, rules and regulations.
• Responsible for compliance with applicable Corporate and divisional policies, GMP and performing duties as assigned by management
  
  

Education And Experience

• Bachelor's degree in either Electrical or Mechanical Engineering ~ Manager not interested in other degrees
• 5+ minimum years of real work experience. Internships, Co-ops, school projects will not be considered.
  
  

Top Skills

• Electrical engineering degree
• 5 years of experience.
• Med device exp ; FDA and ISO13485.
  
  

Interview Process

• Phone Screen or video with Brian then 2nd round will be In-person meeting for local candidates and video meeting for candidates willing to relocate at own expense.
• Question ~ Will be testing components or off the shelf? A = electrical mainly off shelf with 25% customized.
• Question ~ How often going past date sheet? A = 75% will be reviewed off data sheet but 25% are own docs so will be hands on with tools like oscilloscope.
• Question ~ Will be working with external resources or internal? A = Mostly internal resources
• Question ~ Are you ok with titles other than Component Engineer as that is very specific? A = Yes because this is more about the "Tasks" the candidate has been doing than the title.
  
  

Thanks & Regards

Kiran Kumar | Senior Recruiter

Email: kiran.o@intellectt.com

Desk Number: 732-412-6999 Ext 259

Direct Number: 732-398-6563

Website: www.intellectt.com

Address: 517 Route 1 South, Suite 1115 Iselin, NJ 08830

In my absence, you may contact Kowshik | Lead |

732-627-1210 | kowshik@intellectt.com