Medical Device, Senior Software Engineering Manager

About PENTAX Medical

PENTAX Medical is a global medical device company focused on flexible endoscopy systems. As a division of HOYA Holdings we develop, manufacture, distribute and service endoscopic equipment used in hospitals and ambulatory surgery centers globally. At PENTAX Medical, our mission is to improve patient care and healthcare delivery worldwide through innovative endoscopic imaging technologies and solutions.

Driven by our commitment to Quality, Clinically Relevant Innovation, and Simplicity, we are more than just an equipment manufacturer, we focus on:

• Endoscopic imaging technology
• Clinical education and physician training
• Infection prevention and reprocessing solutions
• Service and Repair support for endoscopy departments
• Senior Manager of Software Development

Location: Montvale, NJ | Hybrid Department: R&D Reports To: Director, US R&D

Why Join PENTAX Medical?

At PENTAX Medical, your work has purpose. PENTAX Medical is a HOYA-owned medical technology company that provides endoscopy imaging systems, scopes, and related services for GI, pulmonary, and ENT procedures, helping physicians diagnose and treat diseases using minimally invasive techniques.

Whether you're supporting commercial operations, developing innovative technologies, manufacturing life-saving devices, or enabling exceptional customer experiences, your contributions help improve healthcare outcomes worldwide.

When you join our team, you'll benefit from:

• A mission-driven organization dedicated to advancing patient care
• A collaborative culture that values innovation, accountability, and teamwork
• Opportunities to make a measurable impact on a growing global business
• Professional development and career growth opportunities
• Competitive compensation and performance-based rewards
• Comprehensive healthcare, wellness, and retirement benefits
• Generous Paid Time Off, sick time, and company holidays
• Flexible work arrangements where applicable

The Senior Manager of Software Development is a hands-on technical and people leader responsible for the architecture, development, and delivery of enterprise-level software products in a regulated medical device environment. This role leads and mentors multiple software engineering teams, drives large and concurrent development programs, and partners across Product Management, Systems Engineering, Verification, Quality, Regulatory, Operations, and other functions to deliver secure, scalable, and maintainable solutions.

The ideal candidate combines strategic technology leadership with active participation in software design, coding, code reviews, troubleshooting, risk management, and lifecycle execution. This leader will build engineering capability, guide pragmatic architecture decisions, and drive disciplined delivery across complex programs.

Key Responsibilities

• Provide technical leadership, architectural direction, and a clear engineering vision for complex software products, platforms, and large development programs.
• Remain actively involved in software architecture, system design, technology selection, coding, design reviews, code reviews, debugging, performance optimization, and critical technical problem-solving.
• Design pragmatic architectures that prioritize maintainability, extensibility, cybersecurity, reliability, scalability, and business value while avoiding unnecessary complexity and over-engineering.
• Drive the full software development lifecycle, including requirements analysis, feasibility estimates, planning, design, coding, documentation, testing, implementation, release, patching, configuration changes, and defect support.
• Manage multiple concurrent projects, including project plans, resource planning, schedules, development timelines, budgets, scope, quality, risk, and delivery commitments.
• Collaborate with Product Management to define product and feature roadmaps and contribute to strategic technology planning and long-term platform direction.
• Maintain, enhance, and modernize legacy software systems while balancing technical debt, product requirements, cybersecurity needs, and long-term architectural goals.

Collaboration & Leadership

• Lead, recruit, mentor, and develop multidisciplinary software teams, including senior engineers and teams of at least five developers.
• Partner with Systems Engineering, Verification, Program Management, Product Management, application specialists, Product Marketing, Operations, Quality Assurance, Regulatory Affairs, and other stakeholders to resolve development issues and deliver compliant products.
• Build a culture of quality, trust, accountability, inclusion, continuous improvement, and innovation.
• Communicate complex technical subjects in clear business terms and influence effectively within a matrixed organization.

Performance & Excellence

• Establish and enforce software engineering processes, coding standards, continuous integration practices, development methodologies, architecture artifacts, and efficient documentation practices.
• Identify technical, schedule, quality, and delivery risks early;
  develop mitigation plans and resolve issues before they create avoidable cost or schedule impact.
• Ensure compliance with company policies, procedures, and applicable medical device software requirements.
• Provide oversight of department expenses and budget planning and perform other duties as assigned by management.

Qualifications

Required Qualifications

• Bachelor's degree in Computer Science, Software Engineering, Computer Engineering, Engineering, or a related technical discipline.
• 10+ years of software development experience, including architecture, design, and coding of large, complex, mission-critical or commercial software products;
  12+ years preferred.
• 6+ years of software engineering management or comparable technical leadership experience with direct reports, including demonstrated success developing senior engineers and leading teams of five or more developers.
• Extensive hands-on experience in an FDA-regulated medical device or healthcare software R&D environment, including IEC 62304. Familiarity with ISO 13485, EU MDR, IEC 62366, ISO 14971, cybersecurity, and data privacy requirements.
• Advanced hands-on experience with C#, WPF, C/C++, .NET, SQL, database development, and Windows-based software.
• Deep knowledge of software architecture, object-oriented design, design patterns, algorithms, data structures, distributed systems, service-oriented architecture, API design and integration, scalability, reliability, and continuous integration.
• Experience with desktop, server-side or backend, web, database, cloud-deployed applications, and multiple deployment platforms.
• Proven ability to lead multiple development teams and concurrent programs while delivering to scope, budget, quality, and schedule expectations.
• Strong people leadership, communication, stakeholder management, team-building, and cross-functional collaboration skills, including the ability to influence without direct authority.

Preferred Qualifications

• Master's degree in a related technical discipline.
• Experience developing commercial software for capital medical equipment and delivering large-scale medical software applications for commercial use.
• Understanding of DICOM and HL7 and experience with medical imaging modalities, visible-light imaging, video-based diagnostic or procedural platforms, or healthcare information systems.
• Knowledge of real-time embedded systems, real-time operating systems, multi-processor and multi-threaded algorithms, device drivers, software/electronics integration, and low-level data links such as SPI, I2C, and serial/UART.
• Experience debugging integrated hardware/software systems using standard tools and equipment.
• Experience developing technology strategies, product roadmaps, architecture blueprints, process harmonization plans, and system integration maps.
• Experience leading global or multi-company teams within a matrixed organization.
• Experience with Microsoft Team Foundation Server and product development lifecycle tools such as Oracle Agile.
• Working knowledge of IEC 60601 and TIR45.

What Will Make You Successful

The successful candidate will demonstrate:

- Strategic mindset and strong system-level thinking

- Ability to build effective teams and develop engineering talent

- Accountability, ownership, and a consistent drive for results

- Collaboration and relationship building across technical and business functions

- Ability to manage complexity, ambiguity, and shifting business priorities

- Commitment to quality, regulated development practices, and operational excellence

Working Conditions & Travel

- Work Environment: Hybrid, Montvale, New Jersey

- Travel Requirements: Up to 10%

- Physical Requirements: Standard office and computer-based work requirements

Benefits & Total Rewards

PENTAX Medical offers a comprehensive benefits package designed to support employees and their families, including:

- Medical, Dental, and Vision Coverage

- Retirement Savings Programs

- Life and Disability Insurance

- Employee Assistance Program (EAP)

- Wellness Resources

- Paid Time Off

- Company Holidays

- Professional Development Opportunities

Benefits may vary based on position and location.

PENTAX Medical is an Equal Opportunity Employer committed to creating an inclusive environment for all employees and applicants. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or any other protected status under applicable law.