Device Engineer

Device Engineer

Hybrid Position: 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 our combination product portfolio.

• 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 our delivery device platform as needed to meet evolving product and regulatory requirements.
• 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 (21
  
  CFR
  820) and Risk Management (ISO 14971).

• Master's degree
• Bachelor's degree and 2 years of experience
• Associate degree and 6 years of experience
• High school diploma / GED and 8 years of experience

• Strong laboratory testing experience, particularly with combination products and medical devices.
• Solid foundation in experimental methods and data analysis.
• Proficiency in statistical tools and methodologies.
• Experience in failure analysis and implementing design solutions.
• Proven ability to collaborate effectively within cross‑functional teams.
• Strong organizational skills and attention to detail, especially in maintaining design history files.
• Familiarity with regulatory and quality requirements for combination products and medical devices.

Pay range is $34 - $39 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job‑related knowledge, skills, and experience.