Senior Combination Product Test Engineer – Drug Delivery Systems & Product Characterization (JP15956)

3 Key Consulting•Cambridge, MA

7d•Onsite

About The Position

This lab-based contract position reports to the Systems Engineering group in Cambridge, Massachusetts. The role independently plans and performs laboratory testing to characterize combination products and drug delivery systems, analyzes results, and communicates findings and recommendations to support engineering decisions. The successful candidate will also help maintain a well-organized, compliant laboratory, including equipment preventive maintenance and calibration. The role applies engineering or scientific principles to practical testing challenges and coordinates effectively across functions. It requires sound judgment, careful documentation, and the ability to manage multiple work activities with appropriate guidance from senior technical staff. This position is 100% on-site.

Requirements

Bachelor’s degree in engineering or a scientific discipline.
At least 4-5 years of relevant professional experience performing laboratory testing, product characterization, or experimental engineering work.
Demonstrated experience planning or executing tests, analyzing data, and documenting technical work.
Strong hands-on skills and interest in working daily in a laboratory environment.
Effective written and verbal communication skills, including the ability to prepare protocols, reports, technical assessments, or presentations.
High attention to detail and a methodical approach to experimental work, data integrity, and material traceability.
Ability to manage multiple priorities and work independently while coordinating with a broader technical team.
Experience with combination products, medical devices, or pharmaceuticals would be especially relevant.
Data analysis and engineering problem-solving
Ability to analyze test results, apply basic statistics, investigate unexpected outcomes, and turn findings into clear conclusions and practical recommendations.
Regulated documentation and technical communication
Working knowledge of GLP and GDP, with the ability to maintain traceable ELN records and independently author or execute protocols and technical reports.
The person should also be able to explain findings clearly to cross-functional partners.

Nice To Haves

Experience in the pharmaceutical, medical device, combination product, or other regulated industry.
Experience with wet-lab methods and product or device testing.
Working knowledge of GLP and GDP.
Experience with statistical analysis tools such as JMP or Minitab.
Experience with 3D modeling or CAD.
Basic programming experience, such as C or Python.
Strong problem-solving, troubleshooting, and root-cause analysis skills.
Organized, collaborative, and adaptable, with the ability to learn new methods and respond to changing project priorities.

Responsibilities

Independently plan and perform hands-on engineering tests and experiments to characterize drug delivery systems and combination products in a controlled laboratory setting, following applicable Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
Operate and troubleshoot laboratory equipment such as 3D printers, tensile testers, viscosity testers, environmental chambers, arbor presses, and basic wet-lab equipment, including transfer pipettes, micropipettes, and balances.
Develop or refine test methods and workflows, identify practical improvements, and recommend changes that improve testing quality, efficiency, or product performance.
Prepare and execute test protocols, document deviations or unexpected results, and author technical reports that clearly summarize methods, results, limitations, and conclusions.
Maintain complete and traceable records of experimental design, materials, methods, techniques, results, and samples in an Electronic Lab Notebook (ELN).
Analyze test data using appropriate statistical methods, draw evidence-based conclusions, and communicate findings and recommendations to technical staff and cross-functional partners.
Investigate test failures, unexpected results, and equipment or process issues; apply structured problem-solving and root-cause analysis to recommend next steps.
Support laboratory readiness by coordinating preventive maintenance and calibration activities, maintaining equipment records, and promoting safe, organized work practices.
Coordinate testing activities and timelines across concurrent projects, proactively communicate risks or changes, and deliver work with limited day-to-day direction.
Share technical knowledge and effective laboratory practices with colleagues and contribute to a collaborative, adaptable team environment.