Engineer, Drug Device Combination Product – Prefilled Syringes / Hybrid (JP13580)

• 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 company’s 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 the company’s portfolio of drug delivery devices.

• Problem solving (engineering skillset)
• Organization (self-starter and project level management)
• Communication (experience communicating at different levels and to different groups)

• 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).

Salary : $36 - $41