Sr. Engineer

MW Partners - Thousand Oaks, CA3.9

ContractEstimated: $91,000 - $130,000 a year
EducationSkills

Job Title: Sr. Engineer

Location: Thousand Oaks, CA

Duration: 12+ Months

Possible Extension: Yes

Description:

The engineer will support technical investigations of combination product complaints associated with product design, manufacturing, and/or usability issues, and support trend and consolidated investigations using data analytics. S/he performs root cause analysis to identify the failure mode for mechanical and/or electromechanical medical devices and associated product components such as packaging, returned due to product complaint using root cause analysis tools and processes. S/he supports trend investigations through the review of manufacturing batch records, evaluation of the returned product, product reserve sample inspections, and review of complaint histories and trends. Upon completion of these activities, s/he will support authoring final reports in accordance with established procedures. This person will own CAPA’s in support of identifying design solutions based on the root cause and will also support cross-functional ideation of design solutions. The engineer maintains close interaction with the device engineering and quality functions to contribute to product improvement.

Responsibilities:

o Understand customer/patient use of Amgen’s packaged and/or distributed mechanical and/or electromechanical products

o Understand manufacturing processes for Amgen’s packaged and/or distributed products

o Support technical trend and consolidated investigations, including statistical assessment of data to identify trends, as well as the generation of monthly reports

o Support cross-functional ideation of design solutions based on the output of root cause analysis

o Support the development and performance of relational data analytics in support of investigations

o Support failure analysis of mechanical and/or electromechanical product to identify root cause using tools such as tolerance analysis, fishbone diagrams, “5 Whys”, and risk assessments such as FMEA’s or Fault Tree Analysis

o CAPA ownership in support of ideation phase

o Provide input to management for trend and failure investigation process improvement

o Support functional management initiatives and objectives

Qualifications:

o Support functional management initiatives and objectives

o Bachelor’s or Master’s Degree in Engineering, preferred Mechanical, Electrical, or BioMed

o 5 or more years of progressive experience as an engineer within the appropriate field of study

o 2 or more years of experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and/or Class III

o Demonstrated experience with mechanical and/or electromechanical medical devices; preferably needle-based injection system – syringe, autoinjector, infuser

o Demonstrated applied 6 Sigma competency, specifically for root cause analysis methodology

o Knowledge of Quality System Regulation – 21CFR820, ISO-11608, and risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA, and other Risk Management tools)

o Experience with protocol and report writing, process and test development and execution

o Strong technical writing and interpersonal skills

If you are qualified, available, interested, planning to make a change, or know of a friend who might have the required qualifications and interest, please call me ASAP at (213)-337-8668even if we have spoken recently about a different position. If you do respond via e-mail please include a daytime phone number so I can reach you.

Also, please take a few minutes to answer some of the questions below as they will help me qualify your candidature

Full Legal Name as in Driving License/ Passport:

Preferred email ID:

Day/ Evening phone numbers:

Current Location:

Work Authorization:

Earliest availability for Phone/ On-Site interview:

Hourly Rate:

Earliest possible start date:

Hoping to connect with you soon.

Thanks & Regards

Vikas Choudhary| SR.*Staffing Specialist
M*W Partners | IT Professionals - Services & Consulting |a Disabled Veteran Business Enterprise
www.mwpartners.net

Office Direct: 213-337-8668

Job Type: Contract

Experience:

  • complaints: 2 years (Required)
  • Medical devices: 1 year (Required)
  • Quality Management: 1 year (Preferred)
  • Engineering: 1 year (Required)

Education:

  • Bachelor's (Preferred)

License:

  • Six Sigma Certification (Preferred)