What will you do
Responsible for all Test Engineering functions and activities for complex Patient Monitoring Systems. Manages a team of Test Engineers and Technicians and oversees the design, development, build, validation, release and support of production tools and test systems. Manages all test related technical aspects of product lifecycle management in Production and at selected contract manufacturers, as well as, test related new product introduction efforts. Key responsibilities also include updating and maintaining existing test strategies, as well as, developing new test technologies. Lead interdepartmental planning between various groups within the company IT security, PS, R&D and Quality to ensure manufacturing operational needs and infrastructure receive appropriate visibility and support to maintain smooth and continuous manufacturing capabilities.
Manages Test Engineering function and a team of approximately 6 Test Engineers and Technicians for the Patient Monitoring Business Unit to include work assignments / role accountabilities, talent acquisition (recruitment), and performance assessment / management. Ensures that all test tools and test systems are thoroughly documented, verified and validated to legal and internal requirements, and operating at the highest possible efficiency.
Manages all test related aspects of lifecycle management and new product introduction in Production and at selected Contract Manufacturers, including development, building, validation and implementation of new and updated production test systems, tools, equipment, and related IT-tools, in compliance with all external regulations and internal procedures.
In addition to management responsibilities, designs, develops, implements and improves manufacturing test systems, tools, & equipment, including custom test hardware and software, and all related design/process documentation. Attention to the serviceability and long-term maintenance of production test equipment should be a fundamental goal.
Works closely with R&D to define Design for Test requirements and testability modes that positively impact manufacturing test effectiveness, efficiency and reliability.
Manages test related projects and drives Continuous Improvement and Operations Excellence initiatives, including LEAN, Six Sigma, Draeger Excellence (DEX), etc. Supports and helps enable an organizational culture focused on Operational Excellence.
Supports Draeger Process Landscape implementation via local roll-out of processes and tools, measurement systems, metrics and key performance indicators.
Responsible for cost center and project budgets; talent acquisition, development and retention through mentoring, coaching, and performance measurement.
Support development of updated and new work processes with automated tools and test capabilities in manufacturing for improving quality & efficiency.
Performs other duties as needed and assigned.
Internal code #LI-MC1 *mon*Who you are
Bachelor's Degree in Electrical, Computer Engineering, or related field; Masters degree preferred
- 15 to 20 years of Test Engineering development experience in manufacturing operations environments, including 7+ years of mixed small signal experience and 8+ years in a management/leadership role required.
- 7+ years in the Medical Device or other regulated industry required, including strong knowledge of FDA GMP/QSR regulations, and ISO standards
- Strong technical skills and commensurate leadership in Test Engineering; familiar with standard industry concepts, good practices, and procedures in Test Engineering
- Proven background in automated test system design architecture and development for manufacturing; experience in coordinating with external test system development partners desired
Strong knowledge of Lean, Continuous Improvement and Operational Excellence methodologies required; multi-plant, multi-site experience involving regional & global partnerships strongly preferred.
- Prior track record of managing regional & multi-site projects around organizational development and change management preferred
- 10+ years of National Instruments LabView/ Test Stand programming experience required.
- Proficiency with Minitab or other statistical software required
- Solid familiarity with SQL interface programing and report generation.
- Solid programming experience/background in C / C++ / Visual Basic
- MS Office proficiency required, MS Access & MS Project preferred
Knowledge of current product development & engineering principles, methods & practices; stays current with new and emerging operations technologies and trends
Ability and experience to perform on both operational and strategic levels, relying on experience and judgment to plan resources and schedules to accomplish goals
Passionate about continuous improvement, LEAN, Six Sigma with demonstrated success in prior projects
Ability to effectively communicate and present information to senior management; excellent problem-solving, interpersonal and administrative skills
Ability to balance and manage competing high-priority work demands