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Product & Process Engineering

Overview

Product & Process Engineering at Fusion focuses on converting concepts into manufacturable products and on establishing robust, repeatable processes that deliver quality, yield, and cost targets. We couple design-for-manufacturability (DFM) principles with process characterization, control strategy development, and documentation to ensure a smooth transition from R&D to production. Our engineering work is practical, compliance-aware, and geared toward reducing time-to-market and minimizing rework during scale-up.

What we deliver

Fusion’s product and process engineering engagements produce tangible technical outputs intended for direct handoff to operations or manufacturers:

Design for Manufacturability (DFM) reviews Design for Manufacturability (DFM) reviews and recommended redesigns to improve tolerance stacks, assembly flow, and testability.
Engineering drawings, BOMs, and CAD models annotated for production, inspection, and supplier fabrication.
Process flow diagrams (PFDs), process maps, and SOPs that document each manufacturing step and handover points.
Process qualification packages (process parameters, acceptance criteria, sampling plans) ready for IQ/OQ/PQ execution.
Control plans and inspection criteria tied to quality objectives and regulatory requirements.
Failure Mode & Effects Analysis (FMEA) outputs and corrective/preventive controls.
Pilot run reports and production readiness reviews that quantify yield, cycle time, and resource needs.

Typical scope & use cases

Common engagements include: new product introductions (NPI) where Fusion supports DFMA and line design; process troubleshooting to address yield loss or variability; scale-up from pilot to full production; and transfer of design to contract manufacturers or internal plants. We also lead process simplification and cost-down exercises for mature product lines.

Methods & approach

Our engineering approach balances speed with rigor:

1. Discovery & Constraints Capture — rapid site or lab assessment to document product requirements, regulatory constraints, supplier capabilities, and current manufacturing architecture.
2. Design Validation & DFM Workshop — cross-functional workshop (design, manufacturing, quality) to identify design changes that reduce assembly complexity and test time.
3. Process Definition & Documentation — produce step-by-step process instructions, tooling lists, control plans, and inspection requirements.
4. Pilot Execution & Optimization — run pilot builds, collect process data, optimize parameters, and update documentation.
5. Production Readiness & Handover — finalize training materials, transfer SOPs, and support the first production runs with onsite technical coaching.
6. Post-Launch Support — monitor early production metrics, recommend process stability improvements, and transition to continuous improvement programs.

Tools & techniques we use

We employ industry-standard and practical engineering tools to accelerate decision-making and documentation: 3D CAD (SolidWorks / Creo / CATIA), tolerance analysis tools, lifecycle PLM basics, process simulation tools, root cause analysis (8D), statistical process control (SPC), and DOE (design of experiments) for process optimization. Our teams are comfortable operating within client toolchains and can adapt to proprietary PLM or MES contexts.

Roles we deploy

Typical team composition for a Product & Process engagement includes: Manufacturing/Process Engineers, Product Design Engineers, CAD/Design Specialists, Quality/Validation Engineers, Test/Fixture Engineers, and Technical Project Coordinators. For scale-ups we add commissioning technicians and line leads to support physical execution.

Compliance & regulated-environment considerations

For regulated sectors (medical device, pharmaceutical equipment), our engineering deliverables are created to satisfy audit and regulatory expectations: traceable design history files, validated process parameter records, documented verification & validation protocols, and risk management outputs (per ISO 14971 or client-specific frameworks). We coordinate closely with quality and regulatory teams to ensure process artifacts map to required submissions and inspection readiness.

Client outcomes (what success looks like)

Clients engaging Fusion for Product & Process Engineering typically realize: shortened design-to-manufacture timelines, reduced assembly complexity, lower scrap and rework rates, predictable yield improvements, and clearer documentation that simplifies supplier onboarding and audit response. Our focus is practical engineering that converts technical work into measurable production benefit.

We do not just provide talent

We provide capability, problem-solving, and services — with speed and cost-efficiency at the core

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