A global contract manufacturing organization serving the medical technology and life sciences sectors is seeking an experienced Engineering Director/ Senior Engineering Director to join its leadership team. Operating within a highly regulated environment, the company partners with leading healthcare innovators to deliver advanced manufacturing solutions through engineering excellence, automation, and operational effectiveness. In this role, you will provide strategic and operational leadership across Manufacturing Engineering, NPI, Test Engineering, Process Engineering, Automation, Industrial Engineering, Product Development, Information Systems, driving engineering performance, innovation, and continuous improvement. You will lead cross-functional teams, support business growth, optimize manufacturing capabilities, and ensure compliance with quality and regulatory standards while delivering exceptional customer satisfaction within a high-mix, low-volume medical device manufacturing environment.
Key Responsibilities
- Lead and develop multidisciplinary engineering teams across manufacturing, testing, automation, product development, and industrial engineering.
- Drive New Product Introduction (NPI) and product transfer activities from concept through commercialization.
- Oversee SMT, PCBA, Box Build, and manufacturing engineering operations to optimize quality, productivity, and cost.
- Lead automation, MES, SAP, and digital transformation initiatives to improve operational efficiency.
- Establish and monitor engineering KPIs, strategic objectives, and continuous improvement programs.
- Partner with customers as the key technical leader, supporting business development and manufacturing capability presentations.
- Drive Design for Manufacturability (DFM), process optimization, yield improvement, and testing strategies.
- Ensure compliance with FDA, ISO, and industry quality standards.
- Manage engineering budgets, resource planning, and talent development initiatives.
- Collaborate closely with Operations, Quality, Program Management, Supply Chain, and Commercial teams to achieve business goals.
Key Requirements
- Bachelor's Degree in Engineering or related discipline.
- Minimum 15 years of engineering leadership experience, including management of large engineering organizations.
- Proven experience within a high-mix, low-volume PCBA, SMT, and Box Build manufacturing environment.
- Strong background in NPI, Manufacturing Engineering, Test Engineering, Automation, and Process Engineering.
- Experience in medical device manufacturing is highly preferred.
- Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001, and related quality systems.
- Experience leading engineering transformation, automation, MES, and SAP implementation projects.
- Strong commercial acumen, customer-facing experience, and ability to influence executive stakeholders.
- Excellent leadership, problem-solving, and strategic planning capabilities.
