Responsibility and Authority:

• The Senior Software Quality Engineer has the authority and responsibility for:

• Ensuring that software developed for new product development projects and changes to existing products achieves desired product quality levels and is in compliance with all applicable regulatory requirements.

• Ensuring successful transfer of software from development into production use.

• Providing leadership in software risk management throughout entire product lifecycle.

• Assuring internal Design Control policies and procedures comply with regulations and external standards, including risk management and change control.

Scope of Duties / Job Description:

• Promote a structured software development process. Assure that a state of control is maintained for in-house and outsourced software development.

• Participate in analysis, design, and change review meetings for product and non-product software.

• Author departmental procedures related to software development.

• Control software release to manufacturing, as well internal distribution.

• Administer problem-tracking database and oversee defect process resolution.

• Provide guidance for the application of internal development procedures, including Design Control, to the product development teams, within the framework of regulatory requirements.

• Author risk management plans and reports. Lead cross-functional teams in system risk analysis and risk control implementation.

• Generate metrics for assessing software quality and evaluate results.

• Create software verification and validation test plans and reports. Manage technicians in test execution.

• Provide engineering expertise and support in supplier auditing of external software vendors.

• Provide training on software development, software validation, and software-related regulations.

• Review Design History Files and Technical Files for conformance to applicable requirements.

Working Conditions:

• No medical conditions preventing access to a controlled environment room.

Education / Training:

• B.S. in Electrical Engineering, Computer Science, Computer Engineering, or equivalent experience.

• 5+ years of experience in the Software Quality Engineering capacity in the medical device industry.

Other Requirements:

• Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.

• Experience applying ISO 14971, IEC 62304, and related standards for software design and development for embedded medical device systems.

• Skilled in applying current Software Quality techniques and industry standards (e.g. IEEE, CMMI) throughout the software development lifecycle.

• Skilled in requirements management and tracing, defect tracking, configuration management techniques, and static and dynamic code analysis.

• Functional knowledge of VHDL or Verilog.

• Understanding of Object Oriented programming techniques.

• Working knowledge of C and C++.

• Experience establishing and implementing software quality metrics for product development.

• Strong collaboration, negotiation, and conflict resolution skills.

• Excellent verbal and written communication skills.

• ASQ CSQE (Certified Software Quality Engineer) preferred.

• Up to 15% travel.

• Other duties as assigned.