Manchester, Greater Manchester - England, United Kingdom
-
Full Time
Start Date
Immediate
Expiry Date
26 Jan, 27
Salary
55000.0
Posted On
28 Oct, 26
Experience
20 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Industry
Manufacturing
Description
Key Responsibilities:Manufacturing Strategy & Scale-Up: Lead the transition from development/low-volume into full commercial-scale production, driving world-class manufacturing readiness.
Supplier & CMO Management: Manage relationships with specialist contract manufacturing organisations (CMOs), precision machining, sterile packaging, and finishing partners to ensure OTIF delivery and tight yield control.
Quality & Regulatory Adherence: Champion operational compliance with ISO 13485, EU MDR, and FDA 21 CFR Part 820 standards, ensuring flawless audit readiness and design transfer rigour.
Process Engineering & NPI: Collaborate closely with R&D, Quality, and Regulatory teams to drive Design for Manufacturability (DFM), process validation (IQ/OQ/PQ), and lean continuous improvement initiatives.
Team Leadership & Culture: Build, mentor, and inspire a multidisciplinary manufacturing and operations team focused on safety, precision, and operational excellence.
About You:Industry Background: Significant manufacturing leadership experience within Medical Devices.
Regulatory Mastery: Deep working knowledge of ISO 13485 and medical device manufacturing controls (FDA / EU MDR).
NPI & Transfer: Proven track record taking complex mechanical/biomaterial products through industrialisation, process validation, and commercial launch.
Commercial & Operational Mindset: Comfortable balancing hands-on problem solving on the shop floor with high-level supply chain strategy and budget management.
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