Description:

The Device Engineer II will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics.

The candidate has technical expertise in the development and commercialization of drug-device combination medical products, and provides technical leadership to support engineering, scientific and manufacturing activities within device development programs, including manual injection systems, automated injection systems, and interfaces with pre-filled syringes and cartridges.

The Device Engineer II will be assigned responsibilities to perform tasks and will assist Senior Device Engineers in identifying and defining critical project steps, and develop practical and thorough solutions to problems.

The candidate will work with general direction and may also supervise staff members. The work is reviewed upon completion.

Job Responsibilities

The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization. This objective will be accomplished by executing activities in the areas of:

Device Engineering:

• Provide guidance and input regarding product development. This includes creation of technical requirements, test methods/fixtures, Verifying requirements through Design Verification and use of engineering analysis tools

• Create drawings (2D, 3D), perform toleance stackup analysis, use statistics and Design of Experiments to evaluate design performance, perform Root Cause Analysis

• Develop and commercialize devices including interfaces with the primary container.

• Regularly interact with external development partners and components suppliers

• Plan and execute test-method validation projects, including developing, performing, and documenting test-method validation activities in accordance with cGMP requirements.

• Write and execute protocols and reports, including integrating the use of appropriate statistical tools in validation protocols, and applying training materials for test methods.

Design Control:

• Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.

• Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.

• Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.

Qualifications

Education and Industry Experience:

• B.S, M.S, Ph.D or advanced degree in Engineering, with preference for Mechanical Engineering, Biomedical Engineering or the equivalent.

• At least 5 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.

• Experience in the Pharmaceutical, Biotech or Medical Device industry is preferred, with previous work on development of injection devices.

Technical Knowledge:

Application of relevant modeling and design tools, design controls and/or statistical analysis.

For example:

• Engineering: Electromechanical system design, System engineering.

• Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.

• Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatibility, Design for Manufacturability, Molding.

• Full data and statistical analysis (JMP, Minitab) and Design of Experiments.

• Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc..

• Six Sigma (Green/Black Belt): DMAIC and DFSS.

Interpersonal Skills:

• Proven track record of working effectively in a matrix organization with a highly cross-functional (e.g., device development, regulatory, clinical, quality, and program management) and collaborative environment is very desirable.

• Excellent oral and written communication skills are required

• Ability to work with external partners is also highly desirable.

• Highly organized and detail oriented