Engineer, Medical Device Test Design and Execution (JP12062)
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Overview
Schedule
Alternate-schedule
Career level
Senior-level
Remote
On-site
Compensation
$37-$41/hour
Job Description
Job Title: Engineer, Medical Device Test Design and Execution (JP12062)Location: Thousand Oaks, CA. 91320Business Unit: Systems EngineeringEmployment Type: ContractDuration: 1+ years (with possible extensions)Rate: $37 - $41/hour W2Posting Date: 12/05/2023Notes: Only qualified candidates need apply. Onsite in Thousand Oaks Mon through Fri with need to 6:00 AM calls to support Demark time zone twice a week. Time on campus will be lab work will be working with lab equipment. There is hybrid opportunity once candidate is seen to be self-sufficient.3 Key Consulting is recruiting an Engineer, Medical Device Test Design and Execution for a consulting engagement with our direct client, a leading global biotechnology company.Job Description:The Mechanical Engineer on the Combination Product Test Team will interact with global and cross-functional members from systems engineering, process engineering, device development, packaging, primary containers, device quality, and other groups. Responsibilities of this position include development, testing, transfer, and life cycle management of multiple autoinjector device commercialization efforts. Test activities will include Engineering, characterization and GMP verification testing and will require a strong proficiency in developing test protocols, statistical analysis, executing hands on testing, and reporting of results to senior leadership.This position will work side by side with experienced Device Test Engineers authoring test protocols, executing test plans, performing data analysis, and finalizing test reports. The successful candidate will employ engineering skills and practices to gather user requirements and translate them into technical documentation for test execution and analysis. The position involves support of senior staff in the initiation, design, and delivery of projects milestones to support verification testing activities.The chosen candidate will frequently spend time in a lab environment working with various types of testing equipment from manual measuring equipment through fully automated testing systems. The devices that will be tested include various iterations of handheld autoinjector drug delivery systems.This role will include numerous collaboration sessions with the test team and global team to trade best practices, discuss issues and resolutions, and create a testing strategy. The chosen candidate may also take part in design and fabrication of test fixtures and processes.Our ideal candidate will have familiarity with medical device engineering and applicable standards, preferably ISO 11608-1, and their application.Top Must Have Skill Sets:
- Strong writing and technical authorship including experience in writing test protocols, statistical data analysis, data verification, and test reports for a technical audience including regulatory agencies.
- Experience working independently to execute test procedures and operate lab equipment (such as analytical balance, tensile tester, and other automated test equipment) while documenting results according to good documentation practices.
- Familiarity with medical device engineering and applicable standards, preferably ISO 11608-1, and their application.
- (50%) Technical authorship of test protocols and reports to support characterization and verification activities. Technical documentation (Test Plans/Protocols/Reports, Engineering Assessments, Design outputs, test-lab equipment/process/control)
- (30%) Hands on execution of test protocols in a lab environment, operating test equipment to collect data and record data according to good documentation practices. Testing of autoinjector devices, including the safe operation of test equipment
- (20%) Statistical data analysis of test results to be included in technical reports.
- Master’s degree OR
- Bachelor’s degree and 2 years of experience OR
- Associate’s degree and 6 years of experience OR
- High school diploma / GED and 8 years of experience
- Candidates with Software or Electrical engineering these are NOT desired for the role.
- No lab experience
- Different industry
- No mechanical or medical device experience.
- Spelling and grammatical errors in resume. Frequent short job durations and job hopping.
- Three to four one-on-one, 30 minute, remote interviews with various team members.
- Able to start interviewing immediately.
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FAQs About Engineer, Medical Device Test Design and Execution (JP12062) Jobs at 3 Key Consulting
What is the work location for this position at 3 Key Consulting?
This job at 3 Key Consulting is located in Thousand Oaks, California, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at 3 Key Consulting?
Candidates can expect a pay range of $37–$41 per hour for this role.
What employment applies to this position at 3 Key Consulting?
3 Key Consulting lists this role as a Alternate-schedule position.
What experience level is required for this role at 3 Key Consulting?
3 Key Consulting is looking for a candidate with "Senior-level" experience level.
What is the process to apply for this position at 3 Key Consulting?
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