Senior Engineer / Biotech Medical Device (JP8473):
3 Key Consulting, Inc.

1201052090
3 Key Consulting, Inc.
Thousand Oaks California
Pharmaceutical
Apply
Description

Job Title: Senior Engineer - Biotech Medical Device (JP8473)

Location: Thousand Oaks, CA. (Remote pending lifting of COVID restrictions)

Employment Type: Contract

Business Unit: Complaints Trending Group

Duration: 1+ years (with likely extensions)

Posting Date: 4/15/21

3 Key Consulting is hiring an Engineer Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

The Sr. Engineer conducts technical investigations of Level 2 and 3 complaints associated with product design and/ or usability issues and conducts trend and consolidated investigations using data analytics. This role understands customer/ patient use of client's packaged and/or distributed mechanical and/or electromechanical product as well as manufacturing processes for these products. The Sr. Engineer owns CAPA's to support identifying design solutions based on root cause and will also participate in multi-functional ideation of design solutions. Also maintains close interaction with the engineering and quality functions to contribute to product improvement. Responsibilities include:

  • Helping with investigation lab infrastructure, equipment setup, personnel training and method development and validation.
  • Lead 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.
  • Perform technical trend and consolidated investigations, including statistical assessment of data to identify trends, as well as generation of monthly reports.
  • Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.

Why is the Position Open?

Supplement additional workload on team.

  • Top Must-Have Skill Sets:Lead 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
  • Perform technical trend and consolidated investigations, including statistical assessment of data to identify trends, as well as generation of monthly reports
  • Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.

  • Day to Day Responsibilities:Perform technical trend and consolidated investigations, including statistical assessment of data to identify trends, as well as generation of monthly reports
  • Lead evaluation of returned product, batch records and review of complaint histories and trends
  • Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.
  • Lead 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.
  • Perform failure analysis using tools and processes 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. (Additional equipment such as CT scanners, FTIR material analysis, Instron tensile test machines and SEM may be used).
  • Lead cross functional ideation of design solutions to reduce complaints based on output of root cause analysis, determine feasibility of options through testing and analysis, develop business plans for implementation.
  • Perform technical trend and consolidated investigations, including statistical assessment of data to identify trends, as well as generation of monthly reports.
  • Lead evaluation of returned product, product reserve sample inspections, batch records and review of complaint histories and trends.
  • Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data.
  • Develop and perform relational data analytics in support of investigations.
  • Advise management for trend and failure investigation process improvement.
  • Provide input to engineering for product improvements
  • Coach and mentor junior engineers.
  • Support functional management initiatives and objectives.
  • Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.

Employee Value Proposition:

Dynamic team, experience in working with a highly talented team.

  • Red Flags:Changing companies within very short (less than 1 year) duration.
  • Resume lacking professionalism.
  • Long duration of unemployment in-between jobs.

Interview process:

Video Skype Panel Interview.

We invite qualified candidates to send your resume to . If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.