Nextern
Director of US Operations
Maple Grove, Minnesota, United States · Director
Sponsorship not specifiedDetected 29 days ago
ComplianceBusiness DevelopmentSupply ChainCadenceFDA RegulatoryMedical DevicesLeadershipCommunicationVariance AnalysisLean Manufacturing
About the role
- 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.
- 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.
Responsibilities
- 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.
- Organizational Design & Leadership 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.
- Drive alignment between site operations and corporate strategy through structured communication and cascaded goal-setting.
- Operational Excellence & Metrics 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.
- Benchmark site performance against industry standards and drive continuous improvement to close gaps.
- Commercial Scale & Capacity Planning 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.
Requirements
- Lead capital expenditure planning, equipment acquisition, and facility expansion initiatives required to support commercial commitments.
Compensation
- Strategy Execution & Cross-Functional Alignment Translate multi-year business strategy into annual operational plans with clear milestones, owners, and success metrics.
Benefits
- Health Care Plan (Medical, Dental & Vision) Retirement Plan with Company Match Paid Time Off, Personal Days, AND Birthday Holiday!
- Lifetime Membership Subsidy and Wellness Resources Life Insurance (Basic, Voluntary & AD&D) Family Leave (Maternity, Paternity) Short-Term & Long-Term Disability Taco Thursdays!!!
Apply directly at Nextern →Create a free account for alerts like thisView Nextern immigration profile
This listing is sourced directly from Nextern's careers page and normalized into a canonical job model.