Engineer, Combination Product Medical Devices3 Key Consulting • Thousand Oaks, CA, United States
Engineer, Combination Product Medical Devices
3 Key Consulting • Thousand Oaks, CA, United States
30+ days ago
Job type
- Permanent
Job descriptionPlan and author technical documentation, including test plans / protocols / reports and a variety of engineering assessments. Perform hands on testing of autoinjector devices, including the safe operation of test equipment and devices containing sharps (syringes). Analyze and report data, along with any recommendations, to a variety of stakeholders. Provide technical input for mechanical problems to programs as needed. Plan and execute tolerance and robustness analysis of complex mechanical designs. Use project planning to monitor and track project deliverables to ensure accurate completion. Collaborate with cross-functional teams to ensure adequate sustainment and improvement of products throughout their lifecycle. As part of the team working on device platforms, ensure alignment of documentation to support variants and combination products. Strong written and oral communication skills Able to execute lab test, which includes safe and proper operation of lab equipment Experience in drug / device combination product design, and development Planning and executing testing, Coordinate material hand-offs, Authoring, reviewing and approving documents, attending and participating in the team meetings (as needed) Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience B.S. in Engineering or Scientific Discipline Effective Communicator (Oral / Written) Technical Writing (Protocols, Reports, Technical Assessments, Presentations) Broad set of knowledge and expertise in contributing to complex, multi-disciplinary and cross-functional product development efforts Experience in drug / device combination product design, and development Background in development, commercialization, and lifecycle management of medical devices Physical test method development, qualification, and validation Experience executing lab tests, including safe and proper operation of lab equipment (Instron tensile tester, Keyence inspection equipment, manual and automated autoinjector testing, CT scanner etc.) Experience conceptualizing, designing, and building test fixtures Technical understanding of drawings including tolerance stacks and robustness analysis Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type / position Familiarity with the following standards : US Good Manufacturing Practices (21CFR820), Quality Management (ISO 13485), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93 / 42 / EEC), Needle Based Injection Systems (EN ISO 11608-1), and Medical Electrical Equipment (EN 60601) Knowledge of dFMEA / pFMEA Capable of working on multiple projects in a deadline driven environment Strong oral and written communication skills, decision making, presentation, and organization skills Ability to collaborate with other disclines within the technical team such as, systems engineering, design engineering, human factors, MSAT, packaging engineering and other functions e.g., drug product, drug substance and product quality. Demonstrate ability to navigate ambiguity and provide a structured problem-solving approach Track record of building or participating as a member of successful teams Working knowledge of MS Office tools, Solidworks, Minitab or JMP and Smartsheet Gaining combination product development experience and a better sense of device performance. Will gain auto injector experience
Job Title : Engineer, Combination Devices Medical Device (JP14307)
Location : Thousand Oaks, CA. 91320
Employment Type : Contract
Business Unit : Final Product Technologies / Development Product Engineering
Duration : 1+ years (with likely extensions and / or conversion to permanent)
Posting Date : 07 / 15 / 25
Pay Rate : $36 - $41 / hour W2
Notes : Only qualified candidates need apply.
- Recent college graduates welcome
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description :
This position reports into the Combination Product Operations Development and Lifecyle Management group in Thousand Oaks, CA. The candidate will support senior staff in device development, characterization, and verification of combination products. This position requires the application of engineering principles to perform the job functions and the ability to coordinate and communicate effectively across different functions to successfully complete projects.
In this role, the candidate will be required to :
Why is the Position Open?
Additional hands for project
Top Must Have Skills :
Day to Day Responsibilities :
Basic Qualifications :
Preferred Qualifications :
Employee Value Proposition :
Interview process : Phone interview(s).
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.
Regards,
3KC Talent Acquisition Team
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Engineer Medical Device • Thousand Oaks, CA, United States
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