Senior Combination Product Test Engineer – Drug Delivery Systems & Product Characterization (JP15956)
وصف الوظيفة
Skills
Hands-on laboratory testing and experimental execution- Experience independently planning and running product characterization or engineering tests, operating lab equipment, troubleshooting issues, and working carefully with samples and materials. 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.
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.
Basic Qualifications
- 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.
Preferred Qualifications
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.Red Flags:- Does not meet the minimum qualifications of at least 4-5 years of relevant experience.
- Has limited recent, hands-on laboratory testing or product-characterization experience; background is primarily theoretical, design-only, or administrative.
- Cannot describe how they maintain accurate, traceable records or follow GLP/GDP practices when documenting test work.
- Has limited experience analyzing test data, troubleshooting unexpected results, or communicating evidence-based conclusions.
- Examples suggest they need close day-to-day direction to plan and complete assigned testing work.
- Cannot meet the role’s 100% on-site requirement in Cambridge, Massachusetts.
Phone screen with manager, then 2-3 interviews with peers. Video-call.
We invite qualified candidates to send your resume to [email protected]. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website [external link] You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.المهارات المذكورة

In 2008, two gainfully employed information technology managers with an entrepreneurial spirit created 3 Key Consulting, a company born from a vision to offer consulting services with an unparalleled dedication to meeting client needs, no matter how difficult the challenge. What started as a determined effort to bridge the gap between talent and opportunity has grown into a robust organization that prides itself on exceeding expectations. The founders' commitment to excellence resulted in an impressive 655% top-line growth by the end of their third year of operations, a testament to the effectiveness of their client-centric approach. The company's evolution is deeply rooted in the concept of a 'professional neighborhood,' a business model built on handshakes, relationships, and long-term trust. By leveraging a significantly large professional network, 3 Key Consulting began recruiting industry leaders and subject matter experts who brought the depth of knowledge and reach of major consulting firms without the layers of overhead. This unique approach allowed them to provide referrals and consultation support that expanded and enhanced the founders' own experience and expertise. Today, 3 Key Consulting has grown its strategic partnerships throughout the U.S. and Asia, supporting over 20 active clients and MSPs. The firm continues to thrive by adhering to its core mission of creating a better work experience for customers, partners, and employees through exceptional dedication and performance. With a focus on people, process, and technology, 3 Key Consulting remains a trusted partner for Fortune 500 companies seeking to navigate the complexities of the modern business landscape.
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