Director, Product Industrialization

Ensera manufacturing site in either Poland or Florida; hybrid eligible based on role needs

The Director, Product Industrialization leads the seamless transition of new products from design and development into stable, compliant, and cost‑effective volume manufacturing. You will ensure designs are scalable from the earliest stage (DFM/DFA/DFX), define the manufacturing strategy, oversee process validation (IQ/OQ/PQ), and uphold quality (ISO 13485) and regulatory requirements (FDA QMSR / EU MDR) while achieving safety, cost, yield, and throughput targets.

You are a commercially aware, customer‑focused leader who brings broad engineering depth and can translate ambiguity into manufacturable, compliant product solutions.

Key responsibilities and knowledge:

• Design Transfer Leadership: Own and continuously improve the Design Transfer process, ensuring a transparent, phase‑gated handover from Design and Development to Manufacturing.
• DFM/DFA/DFC/DFX Strategy: Champion Design for Manufacturability (DFM), Design for Automation (DFA), Design for Cost (DFC) and Design for Excellence early in the product lifecycle to reduce unit costs, manufacturing risks and ensure a successful outcome. Define manufacturing strategy and factory readiness (process flow, line design, staffing, training, tooling/fixtures, MES/traceability, maintenance).
• Process Development and Validation
  :
  Oversee the development of stable manufacturing processes, including the execution of Installation, Operational, and Performance Qualifications (IQ/OQ/PQ).
• Injection molding, Equipment and Automation
  :
  Drive the strategy for sourcing, installing, and validating new production machinery, injection molding tools and automated assembly lines.
• Supply Chain Integration
  :
  Partner with Supply Chain to find, select and qualify key suppliers for components, ensuring raw material scalability.
• Risk Management
  :
  Lead risk assessments (PFMEA) to identify and mitigate potential failure modes in the design and production processes.
• Safety First (Safety, Health & Environment SHE):
  Model a “safety first” culture aligned to ISO 45001 principles. Integrate SHE risk assessment into design transfer and process development. Ensure compliance with site SHE procedures, incident learning, and continuous improvement of leading/lagging indicators.
• QA/RA: Has a depth of understanding of quality and regulatorily needs in an ISO 13485 environment, to navigate a product with key stakeholders from concept to commercialization. Champion quality systems and device regulations (ISO 13485; FDA QMSR aligned with ISO 13485; EU MDR), partnering with QA/RA to embed compliance in processes and documentation.
• Program Management: Own program delivery metrics (safety, quality, OTD, cost, cash/capex, readiness) and can communicate program status to senior stakeholders and customers.

Leadership Competencies (aligned to Ensera Values):

Find a Way: Resourcefulness and learning agility—experiments, learns fast, and scales what works. Innovates under constraints; simplifies complex problems and removes waste. Bias for action with good judgment; escalates early when risks threaten safety, quality, or delivery.

Care: Champions safety, wellbeing, and safety; ensures every voice is heard. Acts with integrity and customer focus in decisions and trade‑offs. Develops people through coaching, feedback, and opportunities; builds diverse and inclusive teams.

Pull Together: Builds trust across Design, Manufacturing, Quality, and Supply Chain; manages conflict constructively. Influences without authority; creates clarity on roles, accountabilities, and decision rights. Communicates clearly and transparently with internal teams and external customers.

• 10+ years in medical devices, pharma, diagnostics, or related regulated manufacturing; equivalent experience considered.
• Proven leadership or experience within Product Design, New Product Introduction / Industrialization and Design Transfer in an ISO 13485 / FDA inspected environment.
• Knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR.
• Degree in Mechanical, Manufacturing, Biomedical, or related Engineering (advanced degree or MBA a plus).
• D…