Katalyst Healthcares & Life Sciences Looking for Quality engineer at San Francisco, CA Full Time

• Excellent employment opportunity for a Sr. Medical Device Engineer in the South San Francisco, CA area.
• The parenteral device development group is responsible for design and development of combination products and medical devices to bring our life changing medicines to patients.
• In this role, you will lead or make strong technical contributions within cross functional combination product development teams and/or to complex technical development and problem-solving projects based on a robust understanding of engineering fundamentals, the product requirements, and business needs.
• Responsible for successful completion of design, development and commercialization deliverables and ensuring that device design, primary container design, component selection, manufacturability and testing specifications and methods meet product needs.
• Effectively collaborate with staff and leaders in Device Development, Quality, Regulatory Affairs, Drug Development, Process Engineering and across other areas of Biologics Product Development and Company.
• Strong communication skills are required including succinct and effective presentation of technical and non-technical materials during meetings with company Senior Management / Leaders, health authorities, audits and other internal and external stakeholders.
• Drug-device combination product and drug delivery device design and development experience
• Lead or be a strong technical contributor to a cross functional team in the selection, development, scale up and/or commercialization of primary containers and/or drug delivery devices for the Company pipeline
• Leads or participates in technically demanding projects within specific area or field of Subject Matter expert.
• Applies engineering principles for the design and development of robust devices/methods/processes that meet patient, molecule and business needs.
• Strong technical capability in solving complex problems using tools such as: mechanistic and statistical modelling and simulation tools, design and prototyping tools, statistical analysis, benchtop experiments and analysis, usability engineering tools, design for manufacturability/assembly techniques and design for six sigma.
• Contribute to departmental combination product and primary container development capability by applying and maintaining a high level of knowledge and expertise
• Establish a close working relationship with and provide effective oversight of suppliers and manage technical aspects of external collaborations.
• Drive a Quality approach and ensure that work is performed in accordance with appropriate quality requirements and compliance to standards.
• Contribute to regulatory filings and health authority responses.
• Develop and implement best practices / business processes

Experience:

• Education: BS and 10 plus or MS and 8 plus or PhD and 0 years of experience.
• 8-12 years of experience in technical roles within combination product and/or primary container development, depending on the highest level of education completed and the level of applicable expertise.
• Strong knowledge of regulations and standards such as design controls, risk management, human factors and industry standards specific to an individual’s subject area (e.g., risk management, Design Controls, FDA QSR, ISO13485, ISO standards etc.)
• Ability to lead a cross functional team and ensure success of the project.
• Experience in working with external development and commercialization partners and suppliers is highly desirable.
• A track record of working effectively within a matrix organization with a highly cross-functional and collaborative environment is required.
• Excellent communication skills are required.
• Familiarity with industry standards and practices applicable to primary container, device and/or combination product development is required.
• Substantial post graduate experience in combination product and device/process development
• Drug-device combination product and drug delivery device design and development experience is essential for this position