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Responsibilities:

• Creating design specifications and requirements definition.
• Developing test protocols/procedures, collecting and analyzing data, and creating detailed reports.
• Optimize systems engineering capabilities using knowledge from standard industry practices and regulatory standards
• Support the engineers during risk assessments and root cause investigations to meet the company metrics for timely handling of complaints and CAPA activities
• Lead and provide technical expertise for the creation of risk management documents (AFMEA, FTA, FMECA).
• Coordinate with program management to establish project scopes, resources needs, priorities and schedules.
• Develop expert knowledge of regulatory standards applicable to medical device and software development life cycle: 21 CFR part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601
• Provide mentorship to the engineers with regards to regulatory standards and application of Stryker's quality procedures.
• Oversee system level verification and validation activities including definition of test strategies, development and validation of test methods, execution of protocols, data collection and documentation
• Manage technical feature risk retirement activities including analyses, prototyping and feasibility activities
• Develop a strong understanding of the clinical application of Stryker's robotic solutions and product line
• Solicit and incorporate the input from surgeons, engineering, sales, marketing, quality assurance and operations to Stryker's product lines

Requirements:

• Bachelor's Degree in Mechanical, Electrical, Computer, Robotics, Aerospace or Biomedical Engineering)
• 5+ years of product design experience in Systems Engineering focused on either Robotics, Orthopaedics or Medical device industry equivalent
• Experienced using MATLAB
• Passion for human anatomy and working within medical device industry
• Experienced in systems engineering principles as it applies to medical device development from concept phase to final design and commercial release.
• Use of risk management practices applied to medical device development.
• Experienced in the use of engineering software for design such as CAD (SolidWorks or PRO-E) and reverse engineering tools (Geomagic & FARO Measurement)
• Experienced in programming image processing and registration algorithms
• Experience with implant development
• Hands on experience with programming Embedded Hardware
• Working in a regulated industry with knowledge of standards and practices
• Experience with tools with DOORS, Jammer, NKS Integrity