The Senior Principal Biomedical System Engineer (Sr. Pr. BMSE) will work as a member of the research and development team in the design, development, testing and integration of electro-mechanical, thermal, and optical sub-systems into new, innovative diagnostic products. The Sr. Pr. BMSE will apply best practice development strategy and advanced technical concepts to solve complex problems, distilling them down to effective product offerings which strike the balance of functionality and usability. The Sr. Pr. BMSE will be guided by a thorough stage gate development process and be expected to resolve complex technical challenges that arise during product development. The Sr. Pr. BMSE will work with a global team within the Veterinary Medicine Research and Development (VMRD) organization, in close collaboration with cross functional teams, including Design and Product Engineers, suppliers, assay scientists, and veterinary medical experts under the direction of VMRD leadership. The person in this position will often coordinate/influence the design efforts of other engineers and developers during a project, although no specific supervisory responsibilities are attached to the job.
A Sr. Pr. BMSE owns primary design responsibility from concept to the completion of the launch phase. The Sr. Pr. BMSE will assist the Engineering and assay development teams ensuring product user requirement specification and performance is met while scaling the product for launch. This will ensure that the operations team is successful in manufacturing readiness, managing supplier readiness for supplied parts, initial install/implementation oversight in customer facilities, and product support (issue resolution) after launch.
The Senior Principal Biomedical System Engineer (Sr. Pr. BMSE) has a wide- and far-reaching variety of responsibilities, including:
• Responsible for the system level conceptual design & development process through completion of the functional prototype phase milestone of the stage gate process. Also participates in ensuring that designs can be implemented into a producible/viable product, in a support role, starting at the final development phase.
• Develop complex diagnostic algorithms (heat, absorbance, phometry, spectroscopy, etc.) with an understanding of the system interactions (electronics, electro-mechanics, thermo-dynamics, and interface to assays)
• Grow and maintain technical knowledge with advancing technology related to technology and product development of in-vitro diagnostic devices.
• Design components, including system level absorbance, immune spectroscopy, etc. solutions and system level requirements. The intent being that the optics/system design will achieve, precision, dynamic range, accuracy, etc. needed to be world class.
• This role would have primary responsibility of the hardware team's interface to the assay team; requiring coordination of system performance as it relates to instrument and consumable architecture, design discussions, and oversight/coordination of integration for complete functionality of the system.
• Design and development of all electro-mechanical and thermodynamic control sequences required by product requirements, while understanding the interface to electrical control systems and underlying biological process needs.
• Prepare documentation for stage gate development activities and efforts.
• Develop and implement mechanical, electrical, and system concept design, perform sensitivity analysis, timing analysis, or other design analysis.
• Assessment of system level risks, and proposing, evaluating and implementing mitigations.
• Ensure designs meet and exceed product specifications, regulatory requirements, and international standards.
• Proficient in communicating complex technical situations in an understandable way.
• Work cross functionally in a global organization, deploy engineering best practices in the context of a stage-gate development process, and navigate satisfying product technical specifications as prescribed by customer and market requirements.
• This position would be responsible/co-own the hardware/software/assay integration and bring-up activities.
• Participate in system engineering for complex electromechanical/thermodynamic/optical systems to define product specifications and controls interactions of each system.
• Coordinate problem solving of design issues.
• Extensive interaction with suppliers in design, analysis and other technical liaison requirements.
• As required, produce detailed drawings, BOM's and release documents for the above design activities.
• Seek opportunities to build new product offerings across the portfolio, consistent with the Zoetis strategy to drive a continuum of care (predict, prevent, detect, and treat) in addressing unmet customer needs.
• Assist in propagating best practices throughout a global engineering team, with emphasis on talent and skill development through influence.
EDUCATION AND EXPERIENCE
• PhD in Biomedical Engineering (PE preferred). Minimum of 20 years demonstrated product engineering experience in a complex engineered product environment. Quality Management System understanding a must.
• 20 years' experience working with Design and Implementation teams, Operations (Manu., Qual., Metrology) and suppliers from an engineering, technical perspective.
TECHNICAL SKILLS REQUIREMENTS
• Familiar with spectrometers, scanners, wide spectrum light sources, optical filtering, etc.
• Familiarity with schematic capture and PCB layout tools for circuit board designs (Allegro, OrCAD, PSpice, CIS, Altium, etc.)
• Familiarity with high density, mixed signal, and high-speed PCB Designs and Layouts (IPC CID or CID+ a plus).
• Microfluidics experience in use for assays, immunoassays, biochemical, and molecular assays
• Proven experience in system design, development, and integration of absorbance, qPCR multi-plex, hematology measurements with in-vitro diagnostics
• Demonstrated understanding of hardware/software partitioning for optimal system solutions, requiring experience in understanding hardware/firmware/system software relationships. .
• Prior experience with the use of mathematical modeling for algorithm development for in-vitro diagnostic assay performance measurements, thermo-dynamics, etc.
• Prior experience with control loop systems for the control of heating and cooling circuits.
• Demonstrated experience with drawing storage/control EDM, EPDM, PLM, SAP, etc. and engineering change management process within PLM environment.
• Proficiency in system level modeling, wire routing, BOM management, and top-level assembly structures.
• Demonstrated proficiency in creating engineering specifications and technical requirements.
• Demonstrated experience in critical thinking and problem-solving skills, planning and organizing, decision-making
• Root cause analysis techniques and documentation.
• Excellent communication skills, influencing and leading, facilitation and teamwork capabilities.
• Prior experience in a regulated industry such as healthcare, laboratory diagnostics, medical devices, or pharmaceutical companies desirable
• Prior experience of taking a project from concept to production coordinating and overseeing mechanical, electrical, and software activities
PHYSICAL POSITION REQUIREMENTS
The Pr. BMSE will work mostly at the Durham, NC site either in an office environment or a development lab environment. Some domestic and international travel is required.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at firstname.lastname@example.org to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.