Job Description

Job Description

The Systems Engineer will work with a cross-functional team to develop and sustain technologies and corresponding systems. The Systems Engineer will drive technical aspects of projects focusing on connected systems and solutions. The candidate will function within a group that acts as the hub of product development within the R&D organization defining the direction of performance requirements, interfaces, subsystem trade-offs and traceability of design control requirements. This role involves utilizing technical knowledge and engineering tools and methodologies to define and connect pieces across different functional elements (Software, Mechanical, Electrical, etc) within a regulated environment. You will ensure the product requirements are defined/maintained and the lower-level functional design teams deliver those requirements.

Responsibilities

Primary Responsibilities

• Define and drive system-level requirements and architectural decisions
• Communicate with users, scientists, and customer-facing associates like marketing and field service associates to finesse the customer experience.
• Develop system and subsystem requirements. Play an essential role in Risk Analysis and Risk Management
• Develop and execute formal and informal test protocols. Use finding to drive decision-making and iterate on the design.
• Utilize modelling tools to simulate and analyze systems, subsystems, and data.
• Communicate requirements and results with the cross-functional teams.
• Provide technical expertise to the Product Development Team and cross-functional project teams to support development objectives.

Knowledge/ Experience

• Bachelor's degree in Systems Engineering, Software Engineering, Mechanical Engineering, Electrical Engineering, Chemical Engineering or related field.
• Experience with computerized control systems.
• Experience with requirements management solutions.
• Experience in developing software and hardware design specifications.
• Experience in requirements traceability.
• Experience performing use case analysis.
• Experience creating and executing test protocols.
• Minimum of 5 years of experience.

Skills/ Abilities Pertinent to This Position

• Ability to work with ALM/PLM Software
• Ability to analyze data.
• Ability to perform requirements analysis.
• Ability to author engineering plans and reports
• Ability to perform trade-off analysis.

Company Description

PBS Biotech improves the lives of patients by providing scalable single-use manufacturing solutions to the cell therapy industry that enable broader access to novel regenerative medicines. The Vertical-Wheel bioreactor provides our customers with a truly scalable platform that is optimized for cell therapy manufacturing requirements, which streamlines their process development and accelerates their time to market.

Company Description

PBS Biotech improves the lives of patients by providing scalable single-use manufacturing solutions to the cell therapy industry that enable broader access to novel regenerative medicines. The Vertical-Wheel bioreactor provides our customers with a truly scalable platform that is optimized for cell therapy manufacturing requirements, which streamlines their process development and accelerates their time to market.