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:
Develop and commercialize devices including interfaces with the primary container.
Provide guidance and input regarding product development.
Provide Process Engineering support for development and commercial products.
Quality Systems Compliance:
Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
Use (and create and implement, if necessary) local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices.
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.
Familiarity with relevant modeling and design tools, design controls and/or statistical analysis.
- Engineering: Electromechanical system design, System engineering, Process/Industrial Engineering, Injection molding and Mold-Flow analyses.
- Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
- Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatability, 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.
- Human Factors Evaluations: Usability engineering and associated risk analyses
B.S, M.S, or advanced degree in Engineering, with preference for Mechanical Engineering, Materials Science Engineering Electrical Engineering, Chemical Engineering, or the equivalent.
At least 2 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 expected, with previous work on development of injection devices required. Must have prior experience working on primary containers, needle safety systems, injection devices with automated features, and container-device compatibility and interactions.