Process & line performance
Process development and time study, cycle time reduction, line balancing, and SOP development under ISO 13485 so training, audits, and the floor stayed aligned.
Operations · Cross-functional
Cross-Functional Ownership
In this chapter of my career, my responsibilities extended beyond mechanical engineering into production leadership, supply chain execution, and quality and regulatory support. This page summarizes the operational ownership I took to scale output, stabilize execution, and support compliant growth in a regulated hardware program.
Mechanical engineering and project work are covered on Projects.
Scope
Program
FDA-cleared medical device
Context
Startup scaling from pilot to production
Areas
Production · Supply Chain · Quality & Regulatory
01
Production Leadership
I owned the path from baseline process understanding to repeatable output: measured work, reduced cycle time, balanced the line, and wrote controlled work instructions. I hired and trained operators, ran day-to-day team leadership with cross-training, and tied forecasting to a practical inventory model the business could run without a full ERP.
Team & capability
Hiring and onboarding operators, team leadership, and cross-training to reduce single points of failure on critical steps.
Forecasting & materials discipline
Forecasting and inventory planning with a Google Sheets-based inventory and reorder system tied to build plans and consumption so commitments matched what we could buy and build.
500 → 1500
units / week
6 to 10
operators hired
95%
line efficiency
<3 weeks
ramp to productivity
02
Supply Chain Execution
I ran sourcing and qualification across a US and Asia supplier base, built second-source options where risk was highest, and managed commercial execution from negotiation through POs, lead time planning, and international logistics. Scorecards kept performance visible as volumes grew.
Sourcing & risk
Supplier sourcing and qualification, a US and Asia supplier base, and a second-source strategy where continuity and cost both mattered.
Commercial & schedule
Cost negotiation, PO management, and lead time planning so engineering milestones and production pulls stayed in sync.
Logistics & performance
International logistics coordination and supplier scorecards to track delivery and quality signals as the network scaled.
15+
suppliers managed
17%
cost reduction
US + Asia
supplier footprint
Second-source
risk mitigation
03
Quality & Regulatory Support
I supported the design history file, change control, and submission-oriented work alongside document control. CAPAs, root cause analysis, and FMEA discipline tied engineering intent to controlled production. Internal audits and MDSAP support stayed focused on evidence, traceability, and closure.
Design history & change
DHF support, design changes and change notices, letters to file, and document control across the release lifecycle.
CAPA & risk
CAPA management and root cause analysis to connect issues to controlled preventive action.
Audits & regulatory alignment
Internal audits and MDSAP support with emphasis on records, objective evidence, and sustainable corrective action.
15+
CAPAs managed
8 audits
0 major findings
regulatory audits
dFMEA + pFMEA
risk management
Full DHF
lifecycle support
Disclosure: Summarized for a portfolio audience. Specific program metrics, supplier details, and commercial figures have been generalised or omitted in line with confidentiality obligations. All outcomes stated are directionally accurate.