Successful candidate will participate in the development of delivery device systems. Scope will include wide range of devices including needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will work on establishing requirements for designing and developing delivery systems with high volume consumable components. The Principle Systems Engineer will work closely with members of the Product Development organization to translate high level product requirements into detailed engineering specifications, and system interface specifications which in turn support the design, development, validation, regulatory submission of these devices. The role of the Principle Systems Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.
• Generate and manage interface control/design documents, device specifications, and system specifications.
• Develop and maintain device requirement traceability among related device and system requirements and specifications.
• Direct system function design and architecture to meet internal and external customer needs.
• Coordinate between various groups to ensure the device meets all requirements.
• Coordinate multi-product system level engineering testing.
• Develop and maintain system engineering processes and procedures to the latest industry standards.
• Monitor all system and subsystem hardware and software integration and acceptance testing.
• Generate, maintain, and track system and sub-system program schedules.
• Identify, evaluate, and track system and sub-system program risks and risk mitigations including technology, development, design interface, sub-system connectivity, and schedule.
• Direct internal cross-functional teams and contract manufactures or design firms to ensure system design, architecture, and verification/validation meets design input.
• Doctorate degree & 2 years of experience directly related to the job OR
• Master’s degree & 6 years of experience directly related to the job OR
• Bachelor’s degree & 8 years of experience directly related to the job OR Associate’s degree & 10 years of experience directly related to the job OR
• High school diploma / GED & 12 years of experience directly related to the job
• BSCS and previous experience in a medical device industry
• 10 years current experience with system engineering processes and procedures.
• Led projects from development through the 510k and PMA approval process.
Broad understanding of software engineering methodologies including software verification and validation strategies.
• Familiarity with lean manufacturing and six-sigma methodology.
• Experience with DOORS, Requisite Pro, or other similar requirements management software.
• Familiar with the following standards:
o US Good Manufacturing Practices – 21CFR820
o Quality Management – ISO 13485
o Risk Management – ISO 14971
o EU Medical Device requirements – Council Directive 93/42/EEC
o Medical Electrical Equipment – EN 60601
• Small scale device assembly experience.
• Experience in model-based design and UML.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Strong problem solving, risk assessment, and risk management skills.
• Ability to converse technically with mechanical, electronic, software, and quality engineers.
• Must be capable of working on multiple projects in a deadline driven environment.
• Must have strong oral and written communication skills, decision making, presentation and organization skills.