Director of US Operations
On-siteMaple Grove, Minnesota, United States
Maple Grove, Minnesota, United StatesOn-siteFull TimeSenior LevelMasters DegreeMedium
Full TimeSenior LevelMasters DegreeMedium
Job Summary
Director of US Operations is a senior leadership role accountable for end-to-end operational performance of Nextern’s US medical device CDMO site, owning site P&L, leading a cross-functional operations team, and serving as the primary architect of organizational structure, operating cadence, and commercial delivery. The role translates business growth into disciplined execution by building systems, teams, and culture to scale from development-phase production to high-volume commercial manufacturing while sustaining quality, delivery, and cost performance for world-class medical device clients.
Required Qualifications
- Senior leadership experience in manufacturing operations within a CDMO or medical device environment
- Experience building scalable organizational structures and leadership across manufacturing, supply chain, quality operations, engineering, and facilities
- Proven ability to design and implement site-level KPI frameworks and robust operational review cadences
- Experience with lean manufacturing methodologies (Kaizen, VSM, 5S) and driving continuous improvement
- Capacity planning and capital expenditure planning for transitioning from development/pilot to commercial scale
- Ability to translate client pipelines into operational readiness plans; collaboration with BD and PM
- Knowledge of regulatory frameworks including 21 CFR Part 820 and ISO 13485; readiness for audits
- Budget ownership, headcount planning, and cost-reduction initiatives
- Strong cross-functional leadership and change management skills
- Executive-level communication and ability to align operations with corporate strategy
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