Director of US Operations

At Nextern, we inspire with passion, impact with significance, and act with integrity.. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide.

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.

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.
• 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.

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.
• 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.

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.
• 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.

Quality & Regulatory Compliance

• 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.

Financial & Business Performance

• 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.

Strategy Execution & Cross-Functional Alignment

• 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.

• Bachelor's degree in Engineering, Life Sciences, Operations Management, or a related field.
• 10+ years of progressive operations leadership experience, with at least 5 years at a site director or equivalent level.
• Demonstrated experience in medical device manufacturing; CDMO or contract manufacturing experience strongly preferred.
• Proven track record of building and scaling operational organizations in a high-growth environment.
• Deep expertise in implementing KPI frameworks and operational review systems that drive measurable performance improvement.
• Strong knowledge of 21 CFR Part 820, ISO 13485, and FDA Quality System Regulation requirements.
• Experience leading commercial scale-up programs, including capacity planning, capital projects, and technology transfers.
• Exceptional organizational design skills — able to architect teams, define accountabilities, and align people to strategy.
• Track record of successfully leading cross-functional alignment in matrixed or multi-site organizations.

Preferred

• Master's degree (MBA, MS Engineering, or equivalent).
• Lean Six Sigma Black Belt or equivalent certification.
• Experience operating within a private equity-backed or venture-funded high-growth company.
• Familiarity with Class II and Class III medical device manufacturing requirements.
• Multi-site or multi-region operations experience.

Salary range:

$140,000 - 180,000 depending on skills and experience