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Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.
The Senior Software Quality Engineering position on the team supports new product development for the Powered Stapling Platform. In this role, the Senior Software Quality Engineer works as part of the quality team supporting the cross functional software development activities. Candidate possesses an understanding of electro-mechanical design and software development process development. An understanding of design for reliability/six sigma is preferred. As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.
POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED:
· 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.
· Support the application of internal development procedures, including Design Control, to the product development teams, within the framework of regulatory requirements.
· Support in the interpretation for industry related regulations within the framework of company 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 facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.
· Represent the quality engineering function as part of a cross functional team in new product and process development,
· Collaborates with cross-functional project team members as well as members of the QA extended team.
· Tracks timelines and facilitating the required Quality Engineering deliverables.
· Assisting with projects and assuring proper and consistent implementation of the quality engineering tools.
· 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.
· Act as a project resource providing leadership in developing/identifying/performing:
o Software Risk Management Plans and Reports
o Risk Assessments including Software Hazard Analyses
o Software Fault Tree Analysis/FMEA’s
o Software Verification and Validation strategies and acceptance criteria
o Software test method development and validation
o Software Reliability Analyses
o Post Market Surveillance Reports
o Cybersecurity Assessment and Evaluation
· Ensure completeness of project software documentation (e.g., DHF).
· Provide engineering expertise and support in internal auditing, external software supplier qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.
· Initiate, lead and follow through with Software update initiatives
· Coordinate and lead software quality related product complaints investigations.
· Ensure all tasks are conducted in accordance with applicable regulatory standards and standard operating procedures
· Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills.
· Demonstrate ability to document test data, analyze test results utilizing statistics, write clear and concise lab reports, and make recommendations to evaluate product.
· B.S. degree in Computer Science, Electrical Engineering, or equivalent field
Preferred: M.S. degree in Computer Science, Electrical Engineering, or equivalent field
· Minimum Experience: 5 years of experience in regulated industry within the Quality, Testing or R&D Engineering function. (2 years of experience can be substituted for an Advanced degree in a related discipline)
• Proven ability to directly lead and/or co-lead multiple tasks and projects.
• Base 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 within a regulated industry (preferably medical devices).
• Working knowledge of the 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.
• Fundamental understanding of mechanical/electrical designs and manufacturing processes to support designing, troubleshooting, refining and qualifying the new product to ensure the sustainable manufacturing of medical devices both internal and external.
NICE TO HAVE
· ASQ Certified Quality Engineering (CQE)
• Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements
· Knowledge of scripting languages and test automation.