Overview
On Site
$33.5 - $36.67 hr
Contract - Independent
Contract - W2
Contract - 12+ mo(s)
Skills
DRUG DELIVERY
COMBINATION PRODUCT
AUTO INJECTOR
SYRINGES
SURGICAL
AUTOINJECTOR
MEDICAL DEVICE
MEDICAL DEVICES
ENGINEER
DOCUMENTATION
TEST
CHARACTERIZATION
VERIFICATION
DEVICE DEVELOPMENT
INSTRON
KEYENCE
TENSILE
CT SCANNER
PROTOCOLS
DESIGN
LAB
LABORATORY
Job Details
Payrate: $33.50 - $36.67/hr.
Summary:
This position is reported into the Combination Product Operations Development and Lifecyle Management group. 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.
Responsibilities:
Requirements:
Top 3 Must Have Skill:
Basic Qualifications:
Pay Transparency: The typical base pay for this role across the U.S. is: $33.50 - $36.67/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ().
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
#25-20900
Summary:
This position is reported into the Combination Product Operations Development and Lifecyle Management group. 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.
Responsibilities:
- 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 sharp (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 robust 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.
Requirements:
- 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
- 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 disciplines within the technical team such as, systems engineering, design engineering, human factors, MSAT, packaging engineering and other functions e.g., drug product, drug substances 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
Top 3 Must Have Skill:
- 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
- Effective Communicator (Oral/Written)
- Technical Writing (Protocols, Reports, Technical Assessments, Presentations)
Basic Qualifications:
- B.S. in Engineering or Scientific Discipline
Pay Transparency: The typical base pay for this role across the U.S. is: $33.50 - $36.67/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ().
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
#25-20900
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.