5131 Device Engineer II
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 the Company’s 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 developing practical and thorough solutions to problems.
Provide guidance and input regarding product development.
Develop and commercialize devices including interfaces with the primary container.
Regularly interface with staff and leaders in Commercial Marketing, Clinical Sciences, Contract Manufacturing, Product Core Teams, Pharmaceutical development, Packaging Development, Quality, and Regulatory Affairs.
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 invalidation protocols, and applying training materials for test methods.
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.
Participate in hazards analyses and design assessments and reviews.
Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.
B.S, M.S, Ph.D or advanced degree in Engineering, with a preference for Mechanical Engineering, Biomedical Engineering or similar.
At least 5 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelor’s degree.
Experience in the Pharmaceutical, Biotech, or Medical Device industry is preferred, with previous work on the development of injection devices required.
Engineering: Electromechanical system design, System Engineering, Process/Industrial Engineering, Injection molding.
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.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.