Key Responsibilities
Own and manage the engineering standard parts library, including mechanical, electrical, and purchased components
Partner with design engineers during concept and detailed design phases to ensure use of approved standard parts
Review and approve new part creation requests to prevent duplication and promote reuse
Define, document, and maintain engineering standards, specifications, and best practices for standard components
Maintain accurate part attributes, NX CAD models, drawings, and metadata within PDM/PLM systems
Collaborate with Manufacturing Engineering and Supply Chain to ensure standards align with sourcing and production capabilities
Support cost, weight, and part-count reduction initiatives through standardization
Analyze part usage data to identify opportunities for consolidation and simplification
Produce detailed drawings utilizing GD&T and CAD Infrastructure engineering best practices.
Produce accurate GD&T tolerance studies.
Participates in the preparation of semi-complex sketches, design layouts, and other specifications.
Support detailed engineering analysis of new and existing designs to verify robustness and design intent.
Design for Excellence (DFX): Apply strict Design for Manufacturability, Assembly, and Serviceability (DFMA) principles to ensure modules minimize laboratory downtime and require minimal manual maintenance.
Cross-Functional Collaboration: Partner closely with Assay R&D, Systems Engineering, Software, and Manufacturing teams to bridge the gap between biochemistry protocols and hardware execution.
V&V and Regulatory Compliance: Author hardware requirements, risk assessments (FMEAs), and execute comprehensive Verification and Validation (V&V) protocols in alignment with ISO 13485 and FDA QSR.
Required Qualifications
Bachelor s degree in mechanical engineering, Manufacturing Engineering, or related discipline
Minimum 5-10 years Industry experience.
Proficiency with NX CAD and PDM/PLM tools
Industry experience in product design, development, and manufacturing with technical background in mechanical assemblies that are related to motion control and structures.
GD&T skills and the ability to perform tolerance stack-ups on complex assemblies.
Familiar with BCT aClass and classification a plus
Familiar with Check Mate, IMM and DFMPro
Strong understanding of design for manufacturability and component selection
Excellent organizational, communication, and cross-functional collaboration skills
Familiarity with industry standards (ISO, ANSI, DIN, ASME, IEC)
Experience working with fasteners, machined parts, electrical components, or COTS hardware
Core Competencies
Engineering judgment and technical rigor
Standardization and reuse mindset
Data governance and accuracy
Influence without authority
Continuous improvement
careers@tekfortune.com
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