SUMMARY OF POSITION:
This position is for a Software Quality Manager with hands on experience and proven success supporting software development and maintenance activities. Candidate should demonstrate proficient experience with quality engineering concepts, including but not limited to design control, risk management, supplier quality, continuous improvement and software life cycle management.
This position offers opportunity to lead initiatives and provides exposure to multiple projects. The candidate will lead and support new product development and sustaining projects to ensure desired software performance and reliability levels are met in compliance with all applicable regulatory requirements and Medtronic Policies and Procedures.
- Support the development and manufacturing of medical devices in conformance with the Quality System Regulation, ISO 13485, Medical Device Directive, ISO 14971, IEC 62304 and other regulatory standards.
- Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control
- Contribute to the streamlining and continuous improvement of the software development and maintenance process to ensure robust and efficient development and launch of new and innovative healthcare products
- Provide guidance for the application of internal development procedures, including Design Control, to the product development teams, within the framework of regulatory requirements
- Provide guidance and interpretation for industry related regulations within the framework of Medtronic product and sustaining development processes
- Interact and form constructive working relationships with all levels of leadership within Quality, Procurement, Marketing, R&D, and Operations
- Utilize coaching and facilitating skills with program shareholders and software quality team members to ensure proper project management, expectation setting, and best practices are utilized.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Act as a project resource providing leadership in developing/identifying/performing:
- Risk Management Plans and Reports
- Risk Assessments including Software Hazard Analyses and Risk Analyses
- Fault Tree Analysis/FMEA's (Software, Design, Application, and Process)
- Design Verification and Validation strategies and acceptance criteria
- Test method development and validation
- Software Reliability Analyses
- Post Market Surveillance Reports
- Cybersecurity Assessment and Evaluation
- Ensure completeness of project documentation (e.g., DHF)
- Provide engineering expertise and support in supplier and internal auditing, external software supplier qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination
- Initiate, lead and follow through with Health Hazard Evaluations and 806 determinations
- Collaborate with plant QA and/or lead Quality Engineering initiatives for the Medtronic manufacturing facilities associated with NPD projects, ensuring quality deliverables have been met
- Coordinate and lead software quality related product complaints investigations
- Ensure all tasks are conducted in accordance with applicable regulatory standards and standard operating procedures
Must Have: Minimum Requirements
- Bachelor's Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality
- OR Advanced Degree in Engineering, Science or technical field with 3+ years of work experience in Engineering and/or Quality.
Nice to Have
- 10 years medical devices experience in Quality, Testing or R&D Engineering position.
- Preferred minimum 2 years experience in managing a team
- ISTQB Certification Advanced Level
- Certified Quality Engineer (CQE)
- Certified Quality Auditor (CQA)
- Knowledge of scripting languages and test automation.
- Managing, coaching and mentoring skills.
- Proven ability to directly lead and/or co-lead multiple tasks and projects.
- Strong understanding of industry expectations in the areas such as voice of customer, software development, requirements analysis, risk management, software testing levels, software reliability, etc.
- Experience with Requirements Management tools, configuration management tools, and defect tracking tools.
- Working knowledge of quality engineering principles, supplier management, and manufacturing operations within a regulated industry (preferably medical devices).
- Proficient with utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.).
- Ability to work with distributed and international teams.
- Strong collaboration, negotiating, and conflict resolution skills.
- Fluid verbal and written communication skills.