Position reporting to the Principal Engineer System V & V.
The overall job of the Senior Engineer System V & V is one of creation and innovation, which leads to the development and introduction into production of new products/processes.
The Senior Engineer System V & V would be responsible for:
Planning, management, and oversight of system-level verification activities for complex medical devices (hardware and software)
Safety risk management per ISO 14971 and related risk-based standards
Verification of compliance to relevant standards (e.g. IEC 60601-1:2005 and collateral standards)
Planning and oversight relating to compliance of new and legacy products with international directives and standards (e.g. RoHS), functioning as a member of cross functional teams by providing technical expertise for projects or subprojects
Preparing time and cost estimates for projects
Providing strong technical contributions to product/process development projects.
- Administers the safety risk management process for new product development.
- Administers the system verification program for new product development.
- Serve as a skill leader and facilitator for FMEAs and Fault Tree Analyses
- Development of system-level verification plans and test procedures / protocols
- Maintain traceability from requirements and design elements to corresponding verification activities
- Coordinate system verification activities across functional areas
- Works with functional management to determine strategies and development opportunities for department.
- Develop requirements and specifications to support Design for Testability and Design for Reliability criteria
- Participate in process improvement activities relating to product quality and new product development
- Develop requirements and specifications for test systems required to support systems verification
- Participate in cross-functional design reviews
- Present verification strategies and test plans for cross-functional review
- Provides technical leadership to teams of engineers and technicians in the pursuit of new technology.
- Provides leadership, consulting and troubleshooting on technical problems that arise in product and process development.
- Provides mentoring and developmental leadership to direct reports and team members in technical areas as well as DFSS and/or DMAIC Six Sigma tools.
- Maintains appropriate communication channels with direct reports and team members.
- Communicates resource or product performance issues to functional management in a timely manner.
- Develops creative and innovative approaches to new processes and products.
- Performs engineering measurements and analysis.
- Records work in design history files.
- Provides written reports, protocols, and personnel assessments as necessary.
- Provides cost and activity accounting period reports as necessary.
- Executes tactical implementation of strategic plans.
- Assures compliance with company Standard Operating Procedures and policies.
- Participates in team decision making.
- Develops team problem solving and communication skills
- Demonstrates skill in the use and care of all tools and equipment.
- Demonstrates knowledge and understanding of Good Manufacturing Practices and all other applicable standards.
- Stays informed about applicable new rules, regulations, and standards.
- Writes engineering test protocols for testing of component parts and integrated systems.
- Prepares progress reports on projects as required.
- Prepares oral presentations for various company meetings.
- Develops and writes specifications for components/systems, product, processes, and packaging/labeling.
- Maintains a clean, safe, and orderly work area.
- Follows all safety procedures.
- Bachelor's degree in Electrical/ Electronics & Mechanical Engineering or related field.
- Master's degree in a relevant engineering discipline, or related field.
- Green or Black belt Six Sigma Certification (DFSS or DMAIC)
- Systems Engineering Certification (e.g. INCOSE ASEP/CSEP)
- ASQ Certification CRE
- Required: Six (6) years experience in engineering practice.
- Minimum Three (3) years experience with systems testing & verification in a medical device development environment (FDA 820 CFR, ISO 13485) or other regulated industry.
- Participation in relevant technical societies