Sr Engineer, System Characterization & CPM

5 - 7 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/21/17
San Diego, CA
5 - 7 years experience
Salary depends on experience
Posted on 09/21/17


  • 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.


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