The candidate will need to have availability to go onsite any day of the week, M-F. Hybrid schedule will be 3-4 days per week for the first 2 quarters and then determined depending on business needs.
The Device Engineer will play a critical role in the design, development, and lifecycle management of drug delivery devices, including prefilled syringes, with a focus on testing and analysis within a laboratory environment. This position requires strong experimental, analytical, and statistical skills to support technical operations and ensure the success of combination product portfolio.
Key responsibilities include:
Conducting hands-on experimental testing to support failure investigations and root cause analysis.
Developing, executing, and refining test procedures to evaluate device performance and functionality.
Analyzing test data and applying statistical methods to derive actionable insights and recommendations.
Supporting design changes by leading testing efforts to assess and validate proposed modifications.
Participating in the scale-up, global launch, and continuous improvement of drug delivery devices.
Collaborating with contract manufacturers and suppliers to ensure device quality and performance standards are met.
Maintaining robust design history files for mechanical and electro-mechanical delivery devices.
Enhancing and expanding delivery device platform as needed to meet evolving product and regulatory requirements.
The ideal candidate will:
Have strong laboratory testing experience, particularly with combination products and medical devices.
Possess a solid foundation in experimental methods and data analysis.
Be proficient in statistical tools and methodologies.
Demonstrate experience in failure analysis and implementing design solutions.
Have a proven ability to collaborate effectively within cross-functional teams.
Exhibit strong organizational skills and attention to detail, especially in maintaining design history files.
Show familiarity with regulatory and quality requirements for combination products and medical devices.
This role offers the opportunity to make a meaningful impact by leveraging technical expertise in a dynamic and innovative environment focused on advancing portfolio of drug delivery devices.
Basic Qualifications
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
Top 3 Must Have Skill Sets:
A. Problem solving (engineering skillset)
B. Organization (self-starter and project level management)
C. Communication (experience communicating at different levels and to different groups)
Day to Day Responsibilities: • Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments. • Plans and conducts work requiring judgment in the independent evaluation, selection, and adaptation and modification of standard techniques/procedures/criteria, and devises new approaches to encountered challenges. • Generates and maintains design specifications, protocol and report writing, prototyping, design of experiments/statistical process control product optimization, design verification & validation, FMEA, etc. • System level root cause investigation • Coordinate and implement design improvements with development partners. • Collaborate with scientists and engineers internally and externally to assess and develop appropriate design and manufacturing specifications. • Accountability of maintaining technical records within product design history files. • Individual contributor with leadership attributes to effectively represent device engineering within a large network/matrix organization. • Working proficiency and familiarity with governing standards and regulations, including Quality System Regulation (21CFR820) and Risk Management (ISO 14971).