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Redwood City, California ALLStem
AllSTEM Connections is looking for a Senior Engineer for a Direct Hire position. This role will be developing and commercializing drug-device combination products and providing life cycle manufacturing support. Essential Duties and Job Functions bull Drug-device combination product development and commercialization bull Work with device development organizations to ensure device development activities including design development, verification, validation, risk management, process validation, and human factors studies are executed per device regulations and industry standards bull Work closely with drug product process development teams to ensure that filling and stoppering process capabilities are taken into consideration in device design and prefilled syringes are consistently manufactured to meet device design requirements bull Lead device assembly equipment selection, qualification and process validation bull Support drug-device combination product regulatory submissions bull Act as a subject matter expert during regulatory agency interactions and partner audits bull Oversee CMOs to ensure successful clinical and commercial GMP production of drug-device combination products bull Provide technical support to resolve manufacturing deviations, conduct complaint investigations, implement corrective actions, review ongoing process monitoring and process improvements bull Support quality in device stability planning bull Manage projects from inception to commercialization bull Travel as required to suppliers and manufacturing sites located around the world bull Coordinate and attend kick-off meetings with CMOs and device organizations bull Provide on-site support for trouble shooting and investigations Knowledge, Experience and Skills bull Requires a BSMS degree in engineering or a related scientific field bull 5-8 years of relevant industry experience in delivery device design development and clinicalcommercial manufacturing bull Must have experience developing drug-device combination products bull Prior experience and deep knowledge of a cGMP related industry is required, within the Biopharmaceutical or Pharmaceutical industry bull Must have knowledge of applicable Quality and Regulatory guidelines bull Must have experience with guiding GMP investigations at contract vendors bull Must work well in cross-functional teams and be able to communicate effectively with external partners, peers, and senior management bull Prior experience managing third party relationships bull Must have strong negotiating and interpersonal skills, and the ability to clearly present recommendations bull Excellent decision-making, leadership, interpersonal, written and verbal communication skills bull Must have strong computer skills, including all MS Office applications bull Must have experience with industry standard design and development tools (CAD, math modeling, tolerance analysis, and statistical software)