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Sr Staff Engineer, Systems

Apply Now Job ID R-322543 Date posted 11/02/2018

Job Description Summary

The Senior Staff Systems engineer will be the Systems Engineering lead on complex product development programs. He/she will be responsible for leading the development of robust and efficient system architectures, ensuring detailed and well tested design of highly integrated, safe and accurate devices and leading the development of test methodologies and procedures for system integration, verification, and validation. This includes managing requirements and risks, as well as establishing and ensuring appropriate processes, best practices and documentation to support development activities. The Systems engineer will be a member of a cross-functional team that develops requirements and test plans, generates systems and component concepts, performs experiments, analyzes data, identifies opportunities and best practices and implements the solutions in hardware and software.

Job Description

RESPONSIBILITIES:

As a leader on the R&D Team:

  • Support the development of a Systems Engineering organization in collaboration with internal and external partners.
  • Leads technical reviews at key project intervals.
  • Ensures quality completion and accuracy of project deliverables including design control elements and applicable regulations from definition of requirements and technical inputs, design elements and technical outputs, and verification and validation that design meets requirements
  • Provide necessary supporting data for regulatory submissions for product approval
  • Manage R&D projects including schedule creation, management, budgets, and communication to core team and upper managements
  • Communicate and implement strategic technical direction for programs
  • Develop technical solutions to complex problems
  • Identify issues with projects or associates, communicate issues, and take appropriate action

Specifically for Systems Engineering Team :

  • Working with Technical Leads, develop the system architecture (which will include electronic, mechanical and software subsystems) for new products
  • Working with Technical Leads, design, document and implement integrated systems that meet system design requirements
  • Create and maintain system-level and sub-system-level requirements, use cases and related usage, human factors, hazards, risk management, and traceability documents
  • Design and manage system interfaces, including configuration management
  • Works with upstream and downstream stakeholders to create designs that meet customer expectations and high-volume manufacturing requirements
  • Contributes to the analysis of marketing and human factors data to identify key design inputs drivers and develop requirements and concepts
  • Actively supports quality engineers and R&D during risk management activities to develop robust designs and mitigate events or conditions that could degrade system performance
  • Support the development of a process infrastructure for integrated hardware / embedded software medical device system development
  • Lead the analysis of internal customer needs in the development of test systems and test system platforms
  • Support the deployment and evaluation of integrated systems in pre-clinical and clinical studies
  • Creates, documents, and tests designs as an individual contributor as needed
  • Support design transfer to manufacturing
  • Support the commercial launch of the final system to the market and support sustaining engineering and marketing during post-launch surveillance.
  • .

EXPERIENCE & EDUCATION:

  • B.S. in Systems Engineering, Biomedical Engineering, Physics, Mechanical Engineering, Electrical Engineering, or equivalent, MS is preferred. 
  • Minimum of 10 years relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Knowledge of international standards applicable to medical devices, including 21CFR Part 820, ISO13485, ISO14971, and IEC60601.
  • Experience with in vitro development, and with medical devices preferred; experience in FDA-regulated environments is essential. Other regulated environments may be considered.
  • Experience as leader of a cross-functional project team.
  • Experience over the full product life cycle is desired.
  • Familiarity with DOORS, Simulink, SysML, Rational Quality Manager, and Rational Team Concert is preferred. Minitab is a plus.
  • Experience with product reliability tools
  • Experience writing product requirements, specifications, test protocols, and test reports.  
  • Expertise with requirement and specification management for regulated products is essential.
  • Experience in industrial design and human factors desirable.

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Primary Work Location

USA MA - Andover

Additional Locations

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