Apply to Engineer, Product Complaints and Investigations (JP11646) - Hybrid

Job Title: Engineer, Product Complaints and Investigations (JP11646)
Location: Thousand Oaks, CA. 91320 - Hybrid
Business Unit: Complaints Trending
Employment Type: Contract
Duration: 1+ years with possible extensions or conversion to FTE
Rate: $37 - $42/hour W2
Posting Date: 07/31/2023
Notes: Only qualified candidates need apply. Must be local to be onsite a few days a week.

3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our client is currently seeking an engineer in our Complaints Trending and Investigation group. This position will report to our Sr. Manager of Complaints Trending and Investigation. The engineer will conduct technical investigations of Level 2 and 3 complaints associated with product design and/or usability issues, as well as conduct trend and consolidated investigations using data analytics. S/he will be responsible for the validity and integrity of the investigations and reports, including the data and its statistical analysis. S/he will also participate and/or lead in cross functional ideation of design solutions. The engineer maintains close interaction with the device engineering and quality management functions to contribute to product improvement and management reporting. Additionally, s/he will support the implementation and validation of the equipment in the investigation lab. Responsibilities include:

Lead root cause analysis of mechanical and/or electromechanical products 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
Perform technical trend and consolidated investigations, including statistical assessment of data to identify trends, as well as generation of monthly reports
Develop and perform relational data analytics in support of investigations
Deliver reports and investigations on time per client and regulatory requirements
Understand customer / patient use of client’s packaged and/or distributed mechanical and/or electromechanical products
Understand manufacturing processes for client’s packaged and/or distributed products
Support the implementation and management of the lab infrastructure, including all equipment used for investigations
Provide requirements for lab and investigational equipment to device development teams in support of new device platforms

Top Must Have Skill Sets:

Technical writing skill is a MUST**
Root cause analysis in an engineering setting** (should be able to truly perform root cause analysis not just have experience in logging complaints)
Strong ability to analyze data generated from a variety of analytical techniques and system is preferred
Previous lab experience is helpful but not required

Day to Day Responsibilities:
Assist senior engineers with the following:

Designing the study and drafting protocols.
Compiling historical data from different analytical systems.
Analyzing the data and presenting the results
Writing summery reports.
Executing of the protocols includes testing in the lab using vacuum decay leak tester, Instron force tester, balance, microscope, pressure chamber, analytical measurement equipment’s like caliper, optical comparator, bore gauges, automated stoppering unit, pipits, and de-crimpers.

Basic Qualifications:

Master’s degree and 3 years of related medical/biopharma development or Operations experience; OR
Bachelor’s degree and 5 years of related medical/biopharma development or Operations experience; OR
Associate’s degree and 8 years of related medical/biopharma development or Operations experience

Preferred Qualifications:

Bachelor’s, Master’s or PhD in Engineering, Science or Biomedical
2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
Experience with statistics and statistical analysis
Demonstrated competency in root cause analysis methodology
Experience with protocol and report writing, process and test development and execution, and writing standard operating procedures (SOP)
Strong technical writing and interpersonal skills
Results-driven and detail-oriented team leader

Why is the Position Open?
Supplement additional workload on team

Red Flags:

Candidate with a schedule that is not flexible, possible OVT
Bachelors degree not in Bioscience or engineering degree

Interview Process:
Phone screen followed by video interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. 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 www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.