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Principal Mechanical Product Engineer, Diagnostics R&D
Union City (California)
The Principal Product Engineer (Pr. PE) 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 Pr. PE 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 Pr. PE will be guided by a thorough stage gate development process, and be expected to resolve complex technical challenges that arise during product development. The Pr. PE will work with a global team within the Veterinary Medicine Research and Development (VMRD) organization, in close collaboration with cross functional teams, including Design Engineers, Quality Representatives, Manufacturing, Purchasing, and Suppliers, under the direction of VMRD leadership. The person in this position will often coordinate/influence the design and launch efforts of other engineers and designers during the course of a project, although no specific supervisory responsibilities are attached to the job.
The Pr. PE owns primary design responsibility once functional prototypes have successfully met product design requirements. During the early design phases the Pr. PE assists the design team, influencing the design for producibility. The Pr PE is responsible for ensuring product performance is met while scaling the product for launch, successfully guiding the operations team for manufacturing readiness, managing supplier readiness for supplied parts, initial install/implementation oversight in customer facilities, and subject matter expert product support (issue resolution) after launch
The Pr Product Engineer (Pr PE) has a wide and far reaching variety of responsibilities, including:
- has a guiding role in the conceptual development process, to ensure that designs can be implemented into a producible/viable product.
- has a technical leadership role in releasing a design into the supply base, manufacturing process, and customer environments.
- Will resolve design issues discovered in functional prototype testing and finalize design for manufacturability (internal and supply base) without compromising product performance.
- will resolve all technical issues arising from First Article submittals, Verification and Validation testing of parts released from production ready tools, and any technical issues which arise in the commercial environment.
- Specific experience in mechanical design, FEA, 3D modeling, CAD Practices, GD&T, etc.
- Collaborate to develop electro-mechanical, fluidic, and thermal management systems while understanding the interface to electrical control systems and underlying biological process needs.
- Participate in developing product specifications, DFMEA, PFMEA, validation test plans, and risk assessments for reporting of product development status/metrics, and updating at subsequent phases.
- Oversee drawing development, participate in drawing change process, drawing dimensioning and review skills to ensure documentation accuracy for proper part release and control.
- Coordinate problem solving and technical support - including managing root cause analysis, interpretation of test results, associated design updates/changes, and oversight of technical issues with the supply base (analysis lead, technical liaison).
- Employ root cause analysis techniques, such as 8 Discipline, 5 whys, and fish bone diagraming of issues.
- Collaborate with manufacturing to ensure technical process development and related documentation align with design and product requirements.
- Oversee build of first article products/critical components to ensure product meets specifications, timelines and budget.
- Actively engages in technical redesign for cost reduction.
- Initiates justification and implementation of new components and technology, when obsolescence occurs.
- As required, produce detailed drawings, BOM’s and release documents for the above design activities
- B.S. in Mechanical Engineering (MSME desired) and a minimum of 15 years demonstrated product engineering experience in a complex engineered product environment. Quality Management System understanding a must.
- 15 years’ experience working with Design and Implementation teams, Operations (Manu., Qual., Metrology) and suppliers from an engineering, technical perspective
- Mechanical engineering understanding of 3D Modeling, FEA, Structural/Stress Analysis, Drawing Management
- Root cause analysis techniques and documentation.
- Demonstrated proficiency in engineering specifications and design for automated equipment.
- Knowledge of materials and manufacturing/construction principles. excellent communication skills
- Demonstrated experience with Solid Works, CAD, drawing storage/control, SAP, and other .
- Demonstrated proficiency with modern engineering tools, such as 3d printing, rapid prototyping, etc.
- Demonstrated experience in critical thinking and problem solving skills, planning and organizing, decision