Overview
On Site
$33.33 - $36.67 hr
Contract - Independent
Contract - W2
Contract - 12+ mo(s)
Skills
ENGINEER
DESIGN CONTROL
DRUG DELIVERY
COMBINATION PRODUCT
COMBINATION PRODUCTS
PREFILLED
SYRINGES
MEDICAL DEVICES
MEDICAL DEVICE
DRUG PRODUCT
DESIGN
DESIGN HISTORY
DHF
GLP
LAB
LABORATORY
STATISTICAL
Job Details
Payrate: $33.33 - $36.67/hr.
Summary:
The Device Engineer will participate in the design, development, and lifecycle management of design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.
Scope includes mechanical delivery devices, such as Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, defend inspection and ensure the follow through of commitments.
Responsibilities:
Preferred Qualifications:
Top 3 Must Have Skill Sets:
Pay Transparency: The typical base pay for this role across the U.S. is: $33.33 - $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 to this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
#25-22037
Summary:
The Device Engineer will participate in the design, development, and lifecycle management of design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.
Scope includes mechanical delivery devices, such as Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, defend inspection and ensure the follow through of commitments.
Responsibilities:
- Adheres to strict documentation practices in a GMP regulated environment
- Engineering competency in all conventional aspects of the subject matter, functional area, and assignments
- Plans and performs work, independently evaluating, selecting, and adapting standard methods, and creating new solutions to engineering problems.
- Authors and reviews technical documentation including protocols, reports, and technical assessments
- Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
- Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
- Maintains device and combination product design history files for assigned products
- Ensure test methods and test protocols are developed in a sound and robust framework with high focus on eliminating test errors
- Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
- Provide general laboratory support including inventory management, sample shipments, and cleanup.
- Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications
Preferred Qualifications:
- Bachelor s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
- Understanding of Mechanical Design Engineering Concepts
- Experience with Final Drug Product and/or Drug Product, medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
- Experience with design controls; including (but not limited to) design verification and transfer
- Understanding of risk assessments including hazard and probability analysis
- Experience with investigations and quality records
- Laboratory and electronic lab notebook experience
- Statistical Analysis software (Minitab or JMP)
- Experience with Instron force testers using BlueHill Universal
- Test method development, GR&R, and text fixture design
- Ability to work independently and dynamically across functional teams
- Strong technical writing and verbal communication skills including technical presentations (i.e., PowerPoint)
- Ability to support complex workstreams under demanding timeline
Top 3 Must Have Skill Sets:
- Hands on Laboratory Experience in a GLP Setting (Science or Engineering Lab)
- Good Communication and Technical Writing Skills
- Statistical Analysis
Pay Transparency: The typical base pay for this role across the U.S. is: $33.33 - $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 to this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
#25-22037
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.