Medtronic, Louisville, CO. Senior Software Reliability Engineer
Position Description
Provide reliability engineering support of image guided systems through the product life cycle. Position may be focused on Pre-Market, Design Assurance activities for new product development; including participation in the reliability assurance of design, manufacturing, and testing of systems and components with an emphasis on software and system engineering. Position may also be focused on the Post-Market Reliability aspects of the product life cycle, including analyzing field data for product improvement opportunities, post-market monitoring activities, etc.
Responsibilities Pre-Market Product Development
- Lead cross-functional design teams in the preparation of Reliability Plans and Software Reliability implementation for software applications and Systems Engineering integration.
- Participate on cross-functional design teams to lead efforts related to DRM activities, especially Design for Reliability activities.
- Provide reliability predictions for systems, subsystems, and software applications.
- Participate in establishing and reviewing specifications/requirements for software applications and related system level requirements. Review changes to designs and processes and assess impact to assure reliability requirements are met. And to assure software reliability requirements are documented at system and subsystem levels.
- Prepare, review and approve verification and qualification of system and subsystem reliability test “cases”/protocols and reports for assigned projects. Provide well-written reports and supporting documentation.
Responsibilities Post Market
- Evaluate field performance of assigned products and software applications by analyzing field data. Investigate and evaluate product field problems, nonconforming products, and software anomalies. Work with Software Quality Engineers and Software Engineers to resolve product performance issues or failures.
- Improve data collection tools, methods and processes for generating failure rates, defect tracking, anomalies, and other product performance data. May include hardware, software, and/or systems.
- Participate in activities to establish and maintain the Risk Management process, including application of ISO 14971. Contribute to hazard assessments and FMEAs.
- Responsible for conducting detailed statistical analysis to tie documented risk levels to observed field results; as well as tying to previous field CAPAs.
- Lead efforts on risk based trending to drive prioritization of event handling.
- Responsible for leading standard potential CAPA triggers based on risk for groups of related or similar events and tying these triggers to the formal risk assessment for a logical continuum of risk levels from field data through identified CAPAs.
- Accountable for streamlining and standardizing post-market risk assessment processes and aligning risk categories across pre and post-market.
- May also include Failure Analysis activities, including software trend analysis, root cause analysis, safety risk management activities, coordinating failure investigation activities with cross-functional groups.
Responsibilities General Activities
- Prioritize and manage multiple priorities effectively with minimal direction.
- Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
- Follow all Quality System Practices as defined by Medtronic Navigation’s practices, policies and Standard Operating Procedures to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.
Basic Qualifications
- B.S./B.A. in Engineering, Software Programming, or similar related field
- 5+ years of previous experience in a reliability engineer position with B.S./B.A.
Specialized Knowledge Required
- Well developed oral and written communication skills.
- Experience working with cross-functional design/development teams.
- Previous experience in managing multiple projects having multiple tasks.
- Facilitate standardized process for trending, risk assessment, and statistical analysis.
Desired/Preferred Qualifications
- Working knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, IEC 62366, IEC 62304.
- Knowledge of statistical techniques and reliability tools. Proficient with data analysis.
- Formal training in Six Sigma methods combined with project deployment experience at the green belt or greater level is highly desirable.
- Highly developed skill set in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes.
- Excellent downward, lateral, and upward communication skills.
- Good balance of high level strategic and detailed tactical thought processes.
- Demonstrated track record of successfully leading projects to completion.
For more information and to apply contact hiring manager Michelle Hackmann with email subject “Req 84646, Sr Software Reliability Engineer”
Or at Medtronic Carrers based on the following summary:
Job Details: Sr Software Reliability Engineer
Requisition: 84646
Category: Regulatory Affairs and QA
Date Posted: October 12, 2012
Open: Yes
Referral Bonus: 1000 USD
HR Contact: Lisa Karas
Business: Surgical Technologies
Division: RTG ST-Surgical Navigation
Department: 173381-SNTBU Qual a Reliab Eng
Location: USA-CO-Louisville
Pay Band: 096
Relocation: No relocation assistance
Job Type: Full Time – Regular
Exempt/Non-Exempt: Exempt
Shift: First
Travel: Percentage 10 – 20%
Experience: Required 5 years
Education: Required Bachelors Degree
