Director of Human Resources

Company Overview
Kaneka Medical America (KMA), a New York-based subsidiary of Kaneka Americas Holdings, LLC, is a key player in bringing high-performance medical device technologies from Japan to North America. It specializes in treating neurovascular conditions through the use of precision-engineered embolization coils designed for minimally invasive procedures. The business is supported by a bicoastal structure, with headquarters in New York City and R&D in Silicon Valley.

Simultaneously, KMA's Liposorber business unit oversees the LIPOSORBER LA-System, an advanced regulated LDL-apheresis platform designed to treat complex lipid disorders (e.g. familial hypercholesterolemia, FSGS) when standard therapies are insufficient. This system stands out for its selective lipid removal technology and is KMA's exclusive distributed product in the U.S. and Canada.

Summary
The Director of Human Resources (HR) provides strategic leadership for all people-related functions across Kaneka Medical America LLC (KMA) and provide occasional support to other divisions within Kaneka Americas Holdings (KAH) as needed. This role reports directly to the Vice President of Human Resources, Learning & Education, and Corporate Communications, with a dotted line reporting relationship to the President of KMA.

The Director is responsible for driving the KMA people strategy in alignment with business objectives growth plans and strict FDA/ISO compliance requirements. In addition to providing strategic leadership, the Director of Human Resources will also support day-to-day HR operations and tactical responsibilities to ensure smooth execution of people programs in a growing, dynamic business environment. This is both a strategic and hands-on execution role.

Success in this role requires a confident and strong-minded leader who can effectively manage conflict and deliver crucial conversations with clarity and conviction. The Director of Human Resources must be capable of navigating complex interpersonal dynamics and providing firm, empathetic guidance to highly skilled team members. The ability to influence, challenge constructively, and maintain alignment across diverse stakeholders is essential.

Strategic Leadership & People Strategy

• Develop and execute a comprehensive people strategy aligned with Kaneka Medical America's vision, quality objectives, and growth plans.
• Establish the HR Agenda and serve as a trusted advisor to the Executive team, offering insights on organizational design, workforce planning, and cultural initiatives.
• Lead the HR function across the business unit, overseeing talent acquisition, employee experience, compensation, benefits, culture, leadership development, performance management, and succession planning.
• Partner with leadership to foster a unified, high-performing culture across a distributed workforce, emphasizing engagement and retention.

Talent Management & Development

• Design and implement scalable recruiting and onboarding strategies to attract top talent in the medical device industry.
• Create and oversee performance management, leadership development, and succession planning programs.
• Partner with leaders to design and implement engagement, retention, and leadership development strategies.
• Analyze HR and operational metrics to evaluate program effectiveness and inform strategic decisions.

Stakeholder Engagement

• Serve as the KMA HR Representative to the Vice President of Human Resources, Learning & Education, and Corporate Communications and top management, providing periodic updates on people strategy, compliance, risk, and workforce planning.
• Collaborate with external partners (e.g., legal, labor counsel, industry associations) to stay current on best practices and emerging trends in FDA-regulated HR management.
• Cultivate a network of professional contacts to support recruitment, learning, and benchmarking.

One Team Culture

• Embed a culture of belonging and of working as 'One Team' into all HR strategies, programs, and practices.
• Reinforce organizational values of accountability, integrity, and collaboration.
• Promote initiatives that strengthen employee engagement and cohesion across KMA.

HR Operations & Budget

• Partner closely with KAH Corporate HR team (Sr. Director, Compensation & People Analytics, etc.) to ensure quality, innovation, and excellent HR service delivery.
• Manage the KMA HR budget, including resource allocation, headcount, compensation planning, and staffing projections.
• Ensure KMA HRIS data integrity, audit readiness, and effective reporting.
• Proactively leverage HR technology platforms (UKG Pro or similar) to drive efficiency and data-informed decisions.

Compliance & Risk Management

• Own all HR compliance obligations, ensuring full adherence to 21 CFR *820.25 personnel training requirements and ISO 13485:2016 Clause 6.2 competency management.
• Develop, maintain, and implement HR policies and procedures to meet FDA and ISO quality systems standards.
• Lead HR preparation for FDA inspections, ISO audits, internal audits, and regulatory submissions; collaborate closely with QA/RA on training matrices, objective evidence, and corrective/preventive actions.
• Monitor regulatory changes affecting HR practices and update policies accordingly.

Innovative - Consistently introduces new ideas and demonstrates original thinking
Team Player - Works well as a member of a group
Leader - Inspires teammates to follow them
Detail Oriented - Capable of carrying out a given task with all details necessary to get the task done well

Ability to Make an Impact - Inspired to perform well by the ability to contribute to the success of a project or the organization

Masters (preferred)
Bachelors of Human Resource Management (required)
Bachelors of Human Resource Administration (required)
Bachelors of Business Administration (required)

10 years: Experience leading HR teams and managing HR budget in a growth environment. Global or cross cultural experience and cultural agility in navigating diverse perspectives. (preferred)
10 years: Progressive HR experience with at least 5 years in a leadership role within FDA regulated industries (Medical Device, Pharmaceuticals, or Biotechnology). Experience working with a growing medical device field sales force required. Demonstrated expertise in FDA inspections, ISO 13485 compliance, training matrix management, and personnel qualification documentation. Proven track record in risk management, compliance program development, and talent strategy. (required)

Skills