Device Development & Testing Engineer – Drug Delivery​/Combination Products; Lab, Failure Analysis, Design Controls

Device Development & Testing Engineer – Drug Delivery / Combination Products

3 Key Consulting is hiring a Device Development & Testing Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Our 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 our client's portfolio of drug delivery devices.

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 client's 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 Amgen's delivery device platform as needed to meet evolving product and regulatory requirements.

Planned Project

• Problem solving (engineering skillset)
• Organization (self-starter and project level management)
• Communication (experience communicating at different levels and to different groups)
• Nice to have: 1-2 years of experience

• 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 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

Missing two or more of the following four items:

• Degree in the field of Mechanical or Biomedical.
• Medical device industry and/or regulated work environment experience.
• Excellent written and verbal communication skill.
• Understanding and experience in:
• Development/commercialization of medical devices and knowledge of manufacturing processes
• Initiating and bringing complex projects to conclusion
• Ability to work independently and dynamic cross functional teams
• Design controls
• Failure investigation
• Applied statistics
• Inability to be present on site/support ATO-site based activities. This is a hybrid role, NOT fully remote.

Screening interview with myself, followed by a panel interview. Following the panel interviews, if a tie-breaker is needed, there may be a 3rd final round to go in depth on specifics the team felt needed further discussion.

We invite qualified candidates to send your resume to