Overview
On Site
Full Time
Skills
Management
Test Plans
Test Equipment
Reporting
Mechanical Engineering
Project Planning
Documentation
Technical Writing
Product Development
Product Design
Lifecycle Management
Test Methods
SAFE
Laboratory Equipment
Inspection
Testing
Stacks Blockchain
Manufacturing
Quality Management
ISO 13485
Risk Management
Medical Devices
ISO 9000
Electrical Engineering
FMEA
Communication
Decision-making
Presentations
Collaboration
Systems Engineering
Human Factors And Ergonomics
Packaging Engineering
Conflict Resolution
Problem Solving
SolidWorks
Minitab
JMP
Job Details
***Onsite***
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.
This role will be required to:
Plan 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.
Basic Qualifications
B.S. in Engineering or Scientific Discipline
Effective Communicator (Oral/Written)
Technical Writing (Protocols, Reports, Technical Assessments, Presentations)
Preferred/Demonstrated Competencies
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
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.
This role will be required to:
Plan 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.
Basic Qualifications
B.S. in Engineering or Scientific Discipline
Effective Communicator (Oral/Written)
Technical Writing (Protocols, Reports, Technical Assessments, Presentations)
Preferred/Demonstrated Competencies
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
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.