Engineer 3 - Pump Systems

Engineer 3 – Pump Systems

JOB SUMMARY

Systems engineer translates the user needs and business needs into the specifications that drive design, implementation, testing of products that are used for collection of blood and blood components, with a special focus on pump systems. Systems engineer will practice design controls in compliance with the quality management systems to deliver products that are effective, safe and compliant. System engineer will coordinate pump system design activities in collaboration with various stakeholders including mechanical, electrical, software, disposables, quality, manufacturing and commercial Teams. Systems engineer will independently conduct design change impact assessment, coordinate technical reviews of the changes, conduct failure analysis and potential risk impact assessment as part of a cross-functional Team.

ESSENTIAL DUTIES

• Translate user and business requirements into detailed product requirement specifications and design specifications for pump systems.
• Use systems thinking to troubleshoot and design complex platforms integrating equipment, software, and disposables, achieving functional and reliability specifications.
• Characterize, design, analyze, and optimize complete pump systems, considering all aspects such as pump selection, tubing layout, software requirements, controls, energy efficiency, and system reliability, to ensure optimal and accurate fluid transfer.
• Define integration and verification plans, defining adequate resources and time for execution of the plans.
• Generate and evaluate alternative solution concepts and document subsystem architectures for pump systems.
• Define and manage project scope to optimize resources and avoid scope creep.
• Independently conduct technical reviews with stakeholders to meet project design objectives.
• Highlight risks and understand how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
• Develop and approve test protocols to perform functional testing and maximize reuse for multiple configurations.
• Lead design changes to implement and enhance features for pump systems in blood collection platforms, ensuring quality and regulatory compliance.
• Support design transfer to enable successful commercialization of complex products.
• Create, maintain and release artifacts in Design History File (DHF), Device History Record (DHR), Device Master Record (DMR).
• Lead defect management meetings to achieve actionable outcomes and maintain good documentation practices.
• Perform failure analyses to prioritize testing and ensure design completeness and product quality.
• Follow technical specification requirements and provide feedback on pump system technical processes and procedures.

OTHER DUTIES AND RESPONSIBILITIES

• Work direction responsibility may include technicians and junior engineers.
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering, preferred.

Experience

• Minimum 4 years experience.
• Two years of GMP manufacturing experience required.
• Minimum 2 years experience with pump systems, testing, and requirements definition

Skills

• Requires demonstrated skills in technical innovation and technical leadership in pump system functionality and fluid dynamics.
• Experience in conducting risk analysis for defects to demonstrate the safety and efficacy of medical devices with pump systems
• Knowledgeable in evaluating designs for serviceability and manufacturability.
• Strong skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, project management, coordination with cross-functional team member, team behavior, and support for junior engineers, technicians, and management.
• Strong technical problem solving skills.
• Mechanical and electronic ability aptitude to assist with equipment troubleshooting.
• Understanding of and adherence to GMP practices and regulations, such as ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 for medical device development.
• Knowledge and ability to implement FDA or regulatory requirements as necessary.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge and use of relevant PC software applications and skills to use them effectively.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Additional Physical Requirements

Requires travel based on business needs.