Mechanical Product Design & Development Engineer – HVCC Systems

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

Bachelors 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