Program Manager · Regulated Environments

Fran Domínguez

Method built where a product failure is an accident and regulation allows no shortcuts. Transferable to medtech, pharma and aerospace.

I lead complex programs from RFQ to SOP where timing, compliance, quality and industrial reality must converge.

Redondela, Galicia · Spain

Fran Domínguez, Program Manager in regulated environments

Method
matters
more than
industry

Senior Program Manager. Two decades leading product programs from RFQ to SOP in automotive passive safety — one of the world's most demanding industrial environments, where a product failure means an accident and regulation allows no shortcuts. Before managing programs, I developed the product from the inside: I hold a registered patent in passive safety (EP 1 980 454 B1 · 2007). That also calibrates judgment.

I coordinate engineering, quality, logistics and finance — across teams in multiple countries — to deliver complex products from RFQ to SOP. On time. On budget.

That training calibrates judgment permanently: technical decisions defensible to the customer, sharp instinct for what can go wrong, and reflexes to spot risk before it escalates. I am now exploring how to bring that method to sectors with a comparable regulatory profile — medtech, pharma, aerospace. The program management fundamentals carry over; the sector-specific regulatory frame is learned in the first few months, as I once learned moving from design to program management.

End-to-end

From concept to customer. No silos.

Zero error

Trained where a product failure means an accident. That calibrates risk permanently.

Cross-functional alignment

I build commitment across engineering, quality, purchasing and customer under regulatory pressure. Clarity aligns more than hierarchy.

Transferable method

APQP, PPAP, DFMEA. Industry-agnostic. Works wherever regulation and complexity meet.

Track
Record

ZF Lifetec
Program Manager
Current

Leading the development and industrialization of airbag systems for JLR/L460, FORD/V710, Renault and Polestar. Simultaneous management of multiple projects with teams distributed across Portugal, China, Spain, Poland, France, United Kingdom and Germany. Primary customer interface for timing, engineering changes, quality and cost.

Land RoverFordRenaultPolestar
11/2018 — Present
Vigo, Spain
TRW Automotive
Application Engineer

Product development of steering wheels and driver airbag modules for major OEMs. Design, validation and series production launch using CAD/CAE, DFMEA and APQP methodologies.

CitroënRenaultDaciaHyundaiOpel
09/2004 — 11/2018
Vigo, Spain
Fico Mirrors
Operations Engineer

Internship for the Master's in Production Organization and Engineering (UPC), carried out in parallel with the engineering position at ThyssenKrupp Drauz. Implementation of PULLSYSTEM (KANBAN) methodology in a plastic injection plant, applying Just-in-Time principles with documented efficiency improvement on the pilot line.

KANBANLeanJIT
05/2004 — 08/2004
Barcelona, Spain
UPC Master Internship
ThyssenKrupp Drauz
Automotive Design Engineer

CAD engineering on SEAT projects. Development and improvement of vehicle components under OEM quality standards.

SEAT
08/2003 — 07/2004
Barcelona, Spain
Edag
Automotive Design Engineer

CAD design and component adaptation for global OEMs. First experience coordinating multidisciplinary technical teams in international environments — Spain and China.

VolkswagenDalphi-Metal / ZF TRW
06/1999 — 08/2003
Martorell, Spain

Real
numbers

0
recalls in over 20 years in passive safety — as Application Engineer and as Program Manager. Zero field incidents on programs where I held direct technical responsibility.
100%
of programs closed without cost overruns passed on to the customer. Internal variances, when they occurred, were managed before reaching the customer.
~400k€
average development budget per program (RFQ → SOP), coordinating teams distributed across up to 7 countries and multi-vendor supply chains.
7
programs closed within the SOP committed to the customer after approved gates — sustained cadence of one launch per year.
6
parallel projects with structured tracking of scope, schedule and risk.
5
countries coordinated across multi-site programs with no direct hierarchical authority.
EP 1 980 454 B1
European patent registered in passive safety (2007). I engineered the product before managing it — an engineering perspective that permanently calibrates technical judgment as PM.

Cases

No industrial secrets here. Just the kind of situations that define whether a PM has real judgment or only manages spreadsheets.

Cost · Safety · Timing

When the customer asks for less and the product cannot deliver it

Tension

Critical component change to cut cost. Purchasing in favor. Tight SOP. Real safety risk on the table.

Decision

I translated technical risk into business language: homologation, liability, recall cost. The customer decided with eyes wide open.

Outcome

The customer dropped the change and prioritized safety. The savings came later through a different route: component redesign without touching the risk profile. No subsequent recall. No warranty claims.

The PM is not the one who says no. The PM is the one who makes the real cost of saying yes visible.
01
Validation · Risk · SOP

A validation failure three weeks before SOP

Tension

Sole-source supplier. Fixed SOP. Renegotiating means contractual cost and reputational damage with the OEM.

Decision

Root cause and supply contingency in parallel from hour zero. Within 72h, an alternative plan and proactive communication to the customer.

Outcome

SOP launched on time. Contingency cost was a fraction of a subsequent recall — and far below the reputational impact with the OEM had the program slipped.

Under pressure, speed of response matters more than the perfect response.
02
Leadership · Global · Influence

Four countries. None of them on your org chart.

Tension

Engineering in Spain. Production in Romania. Quality in Poland. Sales in Germany. Program 2021–2023. No formal authority over any of them.

Decision

I built commitments, not tasks. Clear RACI, working cadence, the impact of every local delay made visible to the global program.

Outcome

SOP on time, no incidents. ~400 k€ development budget closed with ~20% final savings vs. baseline. Zero escalations to leadership to unblock cross-country issues.

Formal authority is the last tool. If you need it constantly, you haven't built enough trust.
03

Building a program where regulation, quality and timing must converge? If you think my profile fits — or just want to exchange views — let's talk.

Let's talk

Where
this
experience
fits

Zero failure tolerance, full traceability, rigorous validation, regulatory audits. The architecture of demand is comparable across sectors; the specific regulatory frame is not.

Where my profile fits best by structure is medtech: design control, risk management and validation have a logic analogous to the passive safety discipline I have internalized. Pharma, aerospace and high-reliability industries share a similar demand profile. Program discipline carries over; the specific regulatory vocabulary of each sector is what comes next.

Download full CV
GMP · GxP · GDP

Pharma · Operations

Industrialization and scale-up under GMP. Traceability, deviation management and validation lifecycles share structure with passive safety programs. The GxP-specific frame — CSV, IQ/OQ/PQ, data integrity — I will learn on the ground.

AS9100 · FAI · APQP

Aerospace · Suppliers

Supply chain with AS9100 requirements and First Article Inspection (FAI). Comparable documentation rigor, similar failure tolerances. The specific frames — Part 21, DO-178C/254 — are learned through sector exposure.

IEC 61508 · IATF · RAMS

High-reliability manufacturing

Power electronics, defense, energy, rail. Where variability is real risk and audits are part of daily operations.

Expertise

Program Management

  • RFQ → SOP program management
  • APQP / PPAP
  • Structured Risk Management
  • Timing and cost control
  • SOP launch / Ramp-up
  • Gate & Design Reviews
  • Engineering Change Management

Engineering & Quality

  • Product Development
  • DFMEA / PFMEA
  • CAD / CAE
  • Validation and testing
  • Industrialization
  • Quality Assurance
  • Internal and external audits

Leadership & Industries

  • Cross-cultural coordination
  • Leadership without direct authority
  • Direct OEM / customer interface
  • Airbag systems · Passive safety
  • Transferability to pharma / medtech
  • Lean Manufacturing / KANBAN
  • Root Cause Analysis
Spanish Native

Mother tongue

English C1

Professional use

Education

2017 — 2018
Master's in Mechatronics, Electronic Engineering, Robotics and Mechatronics
University of Vigo · Vigo
2003 — 2004
Master's in Production Organization & Engineering and Industrial Plant Management
Universitat Politècnica de Catalunya (UPC) · Barcelona
1991 — 1999
Industrial Engineer, Mechanical specialty
Universitat Politècnica de Catalunya (UPC) · Barcelona

otcatnoc
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I usually respond within 24 hours on business days. No agenda, no pressure — discretion assumed.