Quantify and document (using functional flow diagrams, p-diagrams, etc) the characteristics/relationships of critical parameters within new and existing instruments, sub-systems, and components.
Drive requirements flow-down, from user needs and system level performance requirements down to module, subsystem, subassembly, component and manufacturing process requirements.
Design and execute DOE’s to understand issues and interactions at various levels of the system architecture, and across various aspects including hardware, software and consumables.
Implement new tools, measurement systems, test fixtures and processes to improve quality, reduce cost, or improve capacity.
Lead the operations team in collaboration with development to set spec levels for new products and challenge existing specs.
Lead cost/benefit analysis efforts for potential projects and take a lead role in project selection.
Collaborate with and lead cross-functional teams (mechanical, electrical, software, optical, fluidic, thermal, etc.) to meet system level performance specs.
Guide a small team of engineers on similar system engineering projects while providing feedback, mentorship, and training.
Support the transfer of instrument subsystems from development to production with an emphasis on a balanced approach to instrument and process capability.
Support development and improvement of incoming, in-line, and end-of-line tests to ensure system level performance meets expectations for new and existing products.
Manage world-wide CM/ODM partners throughout the new product transfer and early production phases to ensure product stability and performance robustness.
BSc/MS in engineering or other technical field along with 5+ years of experience is required; Advanced degreepreferred.
Strong background in Critical Parameter Management; demonstrated effective use of DOE and root cause analysis are required.
Deep understanding and demonstrated experience in requirements decomposition and flow-down for complex systems required.
Strong data analytics background is required; experience with JMP, SQL, and JAMA a plus.
Demonstrated technical leadership within the NPI environment, including multiple concurrent projects is preferred.
Comfortable with complexity and ambiguity, with an ability to see the big picture. Ability to collect, prepare, and present relevant information to influence decision-making within the organization is critical.
Requires strong analytical, written and verbal communication skills as well as the ability to interface with all departments.
Experience in medical device product development and design controls is preferred.
Knowledge and skills in process and product validation of a variety of equipment and processes used to build medical products, particularly ISO 13485 and FDA QSR experiencepreferred.
Exposure to LEAN/Six Sigma/Design For Six Sigma methodologies a plus.
Familiarity with sequencing, optical imaging, thermal systems, chemistry/biology are preferred.
Experience with Measurement Systems Analysis is required.
Demonstrated use and understanding of Product Data Management Systems, Change Control processes and New Product Introduction required; knowledge of SAP PLM a plus.
International and domestic travel of up to 20% required.
Experience interacting with CM/ODM partners a plus.