Device Combination Products

Merck•Rahway, NJ

1d•Onsite

About The Position

Are you passionate and motivated about developing tailored testing strategy for unique combination products? Join our Company’s Device Development & Technology team as Senior Engineer/Scientist and be at the forefront of innovation, leading the charge in designing and implementing specialized testing methodologies for each combination product we develop. We are seeking individuals with expertise in test method development/validation and design verification for the development and commercialization of combination products, including prefilled syringes, auto-injectors, on-body infusers/injectors, inhalers, and more. As a subject matter expert in medical device and combination product design verification, the candidate will lead the strategy and execution of design verification activities from concept to commercialization. As part of our dynamic and diverse team of experts, the candidate will spearhead the technical and scientific feasibility evaluation of the combination product and its components. The candidate will be responsible for establishing design input requirements and essential drug delivery outputs (EDDOs) and developing the respective design verification testing strategy and execution plan. The candidate’s expertise in testing methodologies development and validation strategies will be crucial in ensuring the reliability and accuracy of our results. Furthermore, the candidate will play a pivotal role in driving seamless technology transfers and conducting investigations as needed for our cutting-edge combination products. Join us and be part of a fulfilling and exciting journey in revolutionizing healthcare through the development of life-changing combination products where your expertise and drive will be valued and celebrated.

Requirements

B.S. in Mechanical Engineering (or an equivalent field) + 6 years relevant industry experience; M.S. in Mechanical Engineering (or an equivalent field) + 3 years of experience in the medical device and/or combination product industry; or a Ph.D. in Mechanical Engineering (or an equivalent field).
Ability to assess program needs, formulate, develop, and execute strategy, proactively identify and mitigate risks, engage, collaborate, mentor, and inspire team members.
Strong working knowledge of ISO standards such as 11608, 11040 performance tests and studies including break loose and extrusion force (BLEF), breakage and burst resistance, dose accuracy, and container closure integrity.
New mechanical test method development, qualification, and validation.
Working knowledge of analytical test method tech transfer processes and procedures (internal and external).
Working knowledge of design controls and risk management processes for medical devices and combination products, including establishment of design inputs, design outputs, design verification, and risk management integration.
Expertise in testing, characterization, and troubleshooting of: Combination product drug delivery device components – plastic, metal, glass, elastomeric materials, etc. – fracture, stress-strain response, friction, hardness, surface roughness, surface energy quantification.
Expertise in testing, characterization, and troubleshooting of: Combination product sub-assemblies (including electro-mechanical) – system tear down analysis, gear ratio optimization, weakest link component identification and optimization, etc.
Expertise in testing, characterization, and troubleshooting of: Material characterization and failure mode analysis and integration with combination product risk management.
Stress-strain testing of different materials under different environmental conditions, i.e., temperature, humidity.
Conduct aging studies (e.g., accelerated and real time) and root cause investigations of drug delivery systems, e.g., inhalers, auto injectors, pen injectors, on-body infusers/injectors, etc…
Experience with analytical or numerical simulation.
Excellent collaboration and ideation skills.
Skilled in laboratory good documentation practices and electronic documentation systems.
Excellent communication skills, written and oral.
Combination Products
Commercialization
Cross-Functional Teamwork
Data Analysis
Design Controls
Design Failure Mode and Effect Analysis (DFMEA)
Design Verification
Device Development
Drug Delivery Technology
Innovative Thinking
Interpersonal Relationships
ISO Standard
Mechanical Testing
Medical Devices
Process Optimization
Project Leadership
Quality Management Systems (QMS)
Tensile Strength Testing
Test Method Validation
Troubleshooting

Nice To Haves

Experience in the development and commercialization of drug delivery combination products from design verification standpoint.
Strong familiarity with regulatory landscape associated with drug delivery combination product design verification requirements.
Strong familiarity with compression/tensile testing (Instron, Zwick, Texture Analyzer), rheology (TA Instrument), metrology/non-destructive inspection (XRCT [Zeiss], Optical microscopy [Keyence], CMM, high speed imaging)
Experience in 3D CAD (Solidworks) and rapid manufacturing techniques (machining, 3D printing) for fixture development and device redesign efforts.
Fluency with industry-related guidance & standards: 21 CFR Part 4, 21 CFR 820, 21 CFR 211, USP <1>, USP <697>, FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics, ISO 13485, ISO 14971, ISO 11608, ISO 11040, ISO 10993, ISO 23908, ISTA 3A/B, ASTM F1886, ASTM D4169, ASTM F1980.

Responsibilities

Lead the strategy and execution of design verification activities from concept to commercialization.
Spearhead the technical and scientific feasibility evaluation of the combination product and its components.
Establish design input requirements and essential drug delivery outputs (EDDOs).
Develop the respective design verification testing strategy and execution plan.
Drive seamless technology transfers.
Conduct investigations as needed for combination products.
Identify lab capability gaps, drive procurement of new equipment, and quickly upskill (also train others) on operation.
Facilitate brainstorming sessions, develop proof of concepts, and generate feasibility data.
Promote and leverage diversity to achieve best outcomes.