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.
- 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.
- 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.
- 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