Sr. Scientist, Device Design Engineer

Job Description

Job Description

As a Senior Scientist in Device Design and Process Development group, you will be part of our R&D team that develops drug delivery systems and combination products.

Key Responsibilities:

• Collaborate with systems engineering team to develop robust set of design input requirements based on user needs and target product profile.

• Gain deep understanding of drug delivery systems from a first principles perspective becoming a subject matter expert on the form, fit and function of the device constituent part of the combination product.

• Apply DFM/DFA principles to interrogate sourced device components or design bespoke device components.

• Develop test plans to understand design space and to ensure device technology is adequately suited for the combination product.

• Conduct or analyze tolerance stack ups utilizing worst-case and statistical methods such as RSS or Monte-Carlo simulation.

• Identify critical to function/safety and critical to process dimensions and ensure adequate controls exist to maintain device performance within acceptable range.

• Conduct testing using tensile tester and or other laboratory equipment and analyze data to inform design development activities.

• Interface with key stakeholders in cross-functional development teams and provide technical insight and leadership on the device design aspects of the development program.

• Travel to OEMs/Suppliers to review product design, functional data, manufacturing processes and conduct due diligence on robustness of their product and process.

• Author design/ process FMEA to capture design related risks and identify appropriate risk controls to ensure robust and efficient device functionality.

• Author protocols, reports, create drawings and specifications to ensure proper documentation of development activities in accordance with relevant SOPs.

• Stay current with new device technologies, relevant worldwide regulations, standards, and effectively share this knowledge with others.

• Understand Process validation activities like IQ, OQ, PPQ etc. Review and approve Process validation documentation.

Education qualifications:

• Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, or related fields with 5 years of design and mechanical testing experience Or

• Master’s Degree in Mechanical Engineering, Biomedical Engineering, or related fields with 3 years of design and mechanical testing experience.

Required:

• Proficient in creating solid models, assemblies etc. using computer-aided design (CAD) and computer-aided engineering (CAE) software such as SolidWorks, AutoCAD, ArtiosCAD etc.

• Proficient in creating and reviewing detailed engineering drawings, applying basic GD&T principles for dimensioning and tolerancing.

• Strong problem-solving, analytical, technical writing and presentation skills with high level of proficiency in utilizing MS Office Suite

• Ability to analyze data using statistical software such as Minitab.

• Hands on experience in developing test methods and fixtures for tensile tester, conducting method feasibility, Gauge R&R evaluation, and method validation.

• Excellent collaborative and communication skills, with a proven ability to work effectively with cross-functional teams and external partners to achieve strategic business goals.

• Ability to perform modeling and structural design of secondary packaging with output for prototyping in multiple materials including paper.

• Knowledge of standards (ASTM/ISTA) for evaluation and qualification of packaging systems.

Preferred:

• Working knowledge of regulatory requirements and standards (21 CFR Part 4, 21 CFR Part 820, ISO 13485, ISO 14971 etc.) and industry standards related to medical device manufacturing is a plus.

• Experience in the design and development of drug delivery systems such as prefilled syringes and autoinjectors.

• Experience in machining, prototyping and 3D printing.

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US and Puerto Rico Residents Only:

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