Ensera is growing, and we’re looking for a Director, Product Industrialisation to help bridge Design & Development with Manufacturing—ensuring new products move smoothly, safely, and compliantly from concept to commercial scale.
In this role, you will lead Design Transfer, drive DFM/DFA/DFX from the earliest stages, and build robust, validated manufacturing processes (IQ/OQ/PQ). You’ll shape factory readiness, partner closely with Supply Chain and QA/RA, and support safe, high‑quality, cost‑effective production in line with ISO 13485, FDA QMSR and EU MDR. We are open to hybrid, working from different countries based on the role needs.
We’re seeking a collaborative leader who can translate complex technical challenges into scalable manufacturing solutions, while fostering a culture built on safety, inclusion, and our values: Find a Way, Care, and Pull Together.
What You’ll Do
- Lead Design Transfer and New Product Introduction across cross‑functional teams and support design and product development in providing manufacturable product solutions.
- Apply DFM/DFA/DFX principles to ensure scalable, compliant manufacturing.
- Oversee process development and validation (IQ/OQ/PQ).
- Drive equipment, automation, and tooling strategies, including injection molding and advanced assembly.
- Lead risk management activities (PFMEA) and champion quality and SHE standards.
- Build strong partnerships across Operations, R&D, Supply Chain, QA/RA, and customer teams.
What You Bring
- Significant experience (typically 10+ years) in regulated medical device, pharma, diagnostics, or related manufacturing environments.
- Proven leadership in NPI, Industrialisation, and Design Transfer.
- Strong knowledge of ISO 13485, FDA regulations (21 CFR 820 / QMSR), and EU MDR.
- Expertise in process validation, risk management, and advanced manufacturing technologies.
- Inclusive leadership style with the ability to influence and collaborate across functions.
Why Ensera
- Opportunity to shape an Industrialisation Centre of Excellence.
- Inclusive, safety‑first culture where every voice is valued.
- Professional development pathways and competitive rewards.
- Salary range will be shared in line with EU Pay Transparency requirements.
How to Apply
Interested? Please send your CV and a short note on a recent NPI or Design Transfer project you’ve led to g.leonard@ensera.com
Ensera is an equal opportunity employer. We welcome applicants from all backgrounds and provide reasonable accommodations at every stage of the recruitment process.
