Senior Systems Engineer

M Force

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Senior Systems Engineer

Position Summary

Our client is searching for an experienced and creative Senior Systems Engineer who will effectively work in cross-functional engineering teams. This position will play a key role in the design, development, testing, and documentation of a complex system with both hardware and software components. Experience/skills to assist with software, hardware and systems integration teams to address complex analytical/hardware issues is required. Additionally, this position will lead Design History File documentation, as well as supporting the capture and tracking of technical risk parameters, design risks, and track to risk management strategies.

Position Responsibilities
 

  • Coordinate, develop, and implement design controls for new product and software development projects from concept to product launch
  • Provide technical leadership role in a cross-functional product development environment.
  • Compile technical data for Design History Files per FDA requirements.
  • Lead cross-functional teams efforts relating to system requirements definition, system functional decomposition and requirements allocation, system architecture definition, system modeling, and requirements traceability and compliance including verification plans and reports.
  • Perform Risk Analyses, including Fault Tree Analysis (FTA), and Failure Mode, DFMA and PFMEA activities.
  • Draft work instructions (WI), SOPs, engineering reports, drawings and necessary documentation in order to release design changes.
  • Designs, defines, implements and / or tests complex system requirements; develops integrated solutions in consideration of scientific, engineering, manufacturing and service disciplines.
  • Proactively identify, communicate, and refer problems or coordination needs to project technical lead. Exercise sound judgment of what to share, refer, and when to seek assistance. Provide timely, accurate, and detailed background data to minimize risks or support problem-resolution or goal achievement
  • Assist R&D team in design transfer to manufacturing engineering and/or suppliers
  • Support global regulatory submissions
  • Work with cross functional team to define and refine user needs & design specifications
  • Ability to prioritize tasks and manage a varied workload, exhibit strong written and verbal communication skills, and interface effectively with peers, cross functional project teams, management, sales, and surgeons
  • Ability to explain sophisticated technical issues to project core team, quality engineers, marketers, and technical writers
  • Lead tasks related to usability verification and human factor validation.

 

Qualifications
 

  • Bachelor’s Degree in related engineering or scientific discipline required; Advanced Degree desirable
  • 4-8+ years’ experience working as a Systems Engineer in Medical Device Industry.
  • Experience with medical device design and development processes that conform to standards including ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
  • Experience with medical devices and specifically software as a medical device, including documenting and managing customer requirements (user needs), system requirements (inputs) and system requirement specifications (outputs).
  • Experience with risk management, human factors analysis, project leadership.
  • Comfort in a start-up environment (fast-paced, fluid responsibilities, changing priorities).
  • INCOSE (international council on system engineering) membership is preferred
  • Experience executing design control activities and design history file implementation per FDA regulations for medical devices/equipment is required
  • Experience in identifying & translating user needs (VOC) into design inputs
  • Ability to verify and validate designs, and understand/mitigate design failure modes
  • Experience with defining test acceptance criteria, and creating test protocols/reports
  • Must have knowledge of FDA class 2 devices – 510k submissions, be someone that drives risk documentation/risk control measures, understanding of those measures and performs validation process with the measures.
  • Strong understanding of system design, electronics, mechanical and software integration.
  • Knowledge of design of experiments.
  • Technical understanding of and experience with best-practice product development methodologies.

M Force Staffing is an equal opportunity employer. All qualified applicants, including individuals with disabilities and protected veterans, are encouraged to apply. In addition to federal law requirements, M Force Staffing complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. M Force Staffing is an E-Verify Employer

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