- 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.