Sr Engineer, Released Product - 29447BR - EN in Tempe, AZ at Stryker Corporation

Date Posted: 4/9/2018

Job Snapshot

Job Description

Essential Duties and ResponsibilitiesThe Sr. Released Product Engineer is responsible for a wide variety of engineering work in support of medical devices including design changes, process/quality improvements and compliance issues. The Sr. Released Product Engineer coordinates and conducts technical studies which will lead to improved products & processes under specific business constraints for existing products while adhering to regulatory requirements and quality standards.
  • Project facilitation and/or team member engagement; oversee design control, risk management and regulatory requirements related to sustainment of new or existing products and services, including (but not limited to) line extensions, design changes and process/product/quality improvements.
  • Troubleshoot product and packaging related issues, determine root cause failure, and implement corrective actions.
  • Support Advanced Quality Assurance with customer complaints related to product and packaging failures.
  • Represent R&D on Continuous Process Improvement Teams.
  • Uses team management skills to influence the design group during product development through product launch.
  • Plan and conduct engineering research, design, development and validation activities.
  • Contribute to department metrics related to quality, customer experience, innovation, people development, and financial performance.
  • Ability to effectively interact within a team environment and with other departments such as Quality, Operations, Regulatory Affairs, Mfg. Engineering, Customer Service, Marketing, Sales, as well as external customers and suppliers.
  • Advanced understanding of statistical analysis principles as they relate to data analysis and testing reports.

Job Requirements

Qualifications (Education, Certifications and/or Experience)
  • BS in Mechanical Engineering, Biomedical Engineering, or related Engineering field
  • 3+ years’ experience
  • Medical device industry preferred
  • Advanced understanding of Statistical Methods and Project Management Principles (formal training preferred).
  • Ability to direct development of an action plan and estimate requirements for resources, (management, tasks, budgets, labor, materials, and time required to complete projects).
  • In-depth knowledge of medical terminology/concepts related to medical devices.
  • Advanced knowledge of FDA requirements associated with the development of medical devices including Design Control and the technical support required for regulatory submissions.
Work Environment
  • Office
  • While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects; reach with hands and arms; balance; stoop, kneel, or crouch; talk or hear.
  • The employee must occasionally lift and/or move up to 25 pounds.
  • The noise level in the work environment is usually moderate.
  • May be exposed to hazardous materials. Employees need to consult MSDS in their work area.
  • Required to wear Personal Protective Equipment to protect against exposure to Bloodbourne Pathogens and chemicals.

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