Job Summary:

The Manager Design Assurance and Regulatory will be responsible for leading the design assurance team that navigates the medical device regulatory environment to develop and launch life impacting medical devices. They will also be the leading voice inside the company and to customers on medical device regulatory perspectives and strategies.
The Manager reports to the VP Engineering and Quality and along with the Operations Quality Manager and the QMS Manager will be a part of the Minnetronix Quality Leadership team.
The Manager will help drive functional excellence in alignment with Minnetronix Key Technology Segment needs by providing leadership, management, and career development for team members within the group. They will be part of the Development Engineering team and will have responsibility for the business performance, meeting financial objectives, and ensuring customer and employee satisfaction. This role is a player-coach position that will also be responsible for Design Assurance team deliverables and direct customer project work.

Job Duties and Responsibilities: 

• Team Leadership
• Lead and manage design assurance engineers who work on cross-functional teams to develop, verify, document and transfer to manufacturing our customer’s medical devices.
• Lead and support customers and teams with input on applicable medical device regulations, agencies, and strategies.
• Provide career development and coaching, define individual and team goals, and maintain performance-based goals 
• Develop workforce & resource assessments for annual operating plan and forward-looking strategic plans to ensure that the DQE group is structured, resourced, trained and staffed to meet needs.
• Collaborates within product development to effectively staff teams.
•  Stakeholder Maintenance 
• Assists Business Development by meeting with potential new customers and providing input and support on proposals as requested
• Communicates regulatory and design assurance information to non-technical stakeholders and customers while evaluating ongoing customer needs and expectations. 
• Effective Delivery
• Ensure project deliverables are met with timeliness, budget adherence, and quality. 
• Helps to create and oversee project estimates and engages in cost management strategies.
• Design Assurance Engineering
• Responsible for creating Design Verification Plan, Risk Management Plan and report, and Compliance Reports
• Audit Test Execution Management, Device Testing, Dry Run Status, Stage Build Process Compliance, and Safety/EMC Test Reports
• May assist in the execution of verification test procedures.
• Ensuring verification configurations tested are production equivalent.
• Review/Approve regression analysis, Trace Matrix, ECOs, DBRs, DV Tool Qualifications, Test Procedures
• Participates/Approves in development of requirements, technical Reviews, test report development, design transfer coordination/support and FMEA, DFMEA development.
• Participates in project/customer meetings and Phase Reviews (Phase 1, 2, and 3)
• Monitor project activities to ensure following Minnetronix Standard Operating Procedures and Best Practices.

Qualifications:

• Bachelor of Science or similar required. Master of Science preferred.
• Minimum 10 years of relevant experience with at least 5 years of leadership experience in medical device development required.
• Demonstrated leadership behaviors including effective communication, critical thinking and decision making, and promoting a sense of urgency for reaching goals. 
• Experience working in regulated environments such as FDA QSR’s, ISO 13485, and/or ISO 9001
• Experience with IEC 60601 and 60529 for the development and associated compliance testing of medical electrical equipment preferred
• Experience with all phases of new product development, from concept through commercialization preferred 

Working Conditions and Requirements:

• Must be authorized to work in the United States