Director of US Operations

Nextern•Maple Grove, MN

About The Position

The Director of US Operations is a senior leadership role responsible for the end-to-end operational performance of Nextern’s US medical device contract development and manufacturing organization (CDMO) site. This individual owns site P&L accountability, leads a cross-functional operations team, and serves as the primary architect of organizational structure, operating cadence, and commercial delivery. The Director of US Operations plays a critical role in translating business growth into disciplined execution — building the systems, teams, and culture required to scale from development-phase production to high-volume commercial manufacturing while sustaining the quality, delivery, and cost performance expected by world-class medical device clients.

Requirements

Senior leadership role
End-to-end operational performance responsibility
P&L accountability
Leadership of cross-functional operations team
Architect of organizational structure, operating cadence, and commercial delivery
Ability to translate business growth into disciplined execution
Experience building systems, teams, and culture for scaling production
Experience sustaining quality, delivery, and cost performance
Experience with 21 CFR Part 820
Experience with ISO 13485
Experience with applicable international regulatory frameworks
Experience leading change management initiatives

Nice To Haves

Experience in a medical device contract development and manufacturing organization (CDMO)
Experience scaling from development-phase production to high-volume commercial manufacturing
Experience with lean manufacturing and operational excellence methodologies (e.g., Kaizen, VSM, 5S)
Experience with NPI transition roadmap
Experience with capacity modeling and resource planning
Experience with capital expenditure planning, equipment acquisition, and facility expansion
Experience developing and maintaining a 12- to 36-month capacity plan
Experience serving as a senior operational point of contact for key client relationships
Experience maintaining a state of continuous inspection readiness
Experience leading site responses to FDA, notified body, and client audits

Responsibilities

Design and build a scalable site organizational structure aligned to growth stage, client commitments, and regulatory requirements.
Recruit, develop, and retain high-performing operations leaders across manufacturing, supply chain, quality operations, engineering, and facilities.
Establish clear roles, accountabilities, and decision rights across all operational functions.
Foster a culture of transparency, urgency, and continuous improvement consistent with a fast-paced CDMO environment.
Drive alignment between site operations and corporate strategy through structured communication and cascaded goal-setting.
Define, implement, and own the site-level KPI framework spanning safety, quality, delivery, efficiency, and people.
Establish a rigorous operational review cadence — daily tier meetings, weekly ops reviews, monthly leadership scorecards — to drive data-driven decisions.
Lead root cause analysis and corrective action processes for recurring performance gaps; hold the team accountable to closure timelines.
Champion lean manufacturing and operational excellence methodologies (e.g., Kaizen, VSM, 5S) to eliminate waste and reduce variability.
Benchmark site performance against industry standards and drive continuous improvement to close gaps.
Support NPI in transition roadmap from development and pilot-scale manufacturing to full commercial production, including capacity modeling and resource planning.
Partner with Business Development and Program Management to translate client pipeline into operational readiness plans in partnership with NPI.
Lead capital expenditure planning, equipment acquisition, and facility expansion initiatives required to support commercial commitments.
Develop and maintain a 12- to 36-month capacity plan that balances client demand, regulatory timelines, and financial constraints.
Serve as a senior operational point of contact for key client relationships, providing transparency into site capabilities, risks, and performance.
Ensure the site operates in full compliance with 21 CFR Part 820, ISO 13485, and applicable international regulatory frameworks.
Partner with Quality leadership to maintain a state of continuous inspection readiness; lead site responses to FDA, notified body, and client audits.
Embed quality ownership at the operations level — reinforcing the principle that quality is built in, not inspected in.
Own the site operating budget, headcount plan, and capital budget; deliver financial commitments with discipline and accountability.
Identify and execute cost reduction and productivity improvement initiatives that improve site margin without compromising quality or delivery.
Provide accurate operational forecasts and variance analysis to senior leadership on a regular cadence.
Translate multi-year business strategy into annual operational plans with clear milestones, owners, and success metrics.
Align site operations with commercial, quality, regulatory, and finance functions to ensure seamless execution of business commitments.
Lead change management initiatives — communicating context, building buy-in, and sustaining momentum through ambiguity.
Perform other related duties as assigned by management.