Director, Software Architecture & Engineering

Olympus Corporation; Center Valley (Lehigh County); Hybrid; USD 144,541 - 216,812; Full time

Benefits offered by this job

Competitive salary range with potential for annual bonus

401(k) with company match

Comprehensive medical, dental, and vision coverage

Generous paid vacation and sick time

On-site fitness center and childcare

Job summary

Olympus Corporation is seeking a Director of Software Architecture and Engineering to lead the architectural strategy for medical devices based in Center Valley, PA. The role offers a hybrid work arrangement nationwide.

The ideal candidate will have 12–15 years of software engineering experience, including senior leadership in regulated healthcare technology. Key responsibilities include driving innovation in IoT-enabled devices, ensuring regulatory compliance, and leading cross-functional teams.

Qualifications

• 12–15 years of progressive software engineering experience, with 5+ years in senior leadership roles in medical devices or regulated healthcare technology.
• Deep expertise in IEC 62304-compliant software development.
• Strong understanding of regulatory audits and submissions.

Responsibilities

• Define and lead long‑term architecture strategy for medical devices and connected health platforms.
• Evaluate emerging technologies in digital health and AI/ML diagnostics.
• Ensure compliance with regulatory standards and oversee software risk management activities.

Skills

Software Engineering Experience

Regulatory Compliance Knowledge

Leadership Skills

Cloud Architecture

Education

Bachelor's or Master's degree in relevant field

Job description

Job Overview

We are seeking a Director of Software Architecture and Engineering to lead the architecture and engineering strategy for medical devices, connected health platforms, and regulated healthcare technologies. The role is headquartered in Center Valley, PA, and offers a hybrid work arrangement nationwide.

Key Responsibilities

• Technology Strategy & Architecture Vision:
  • Define and lead long‑term architecture strategy for medical devices and connected health platforms.
  • Drive innovation in SaMD, embedded systems, IoT‑enabled devices, and cloud integration.
  • Align engineering strategy with product roadmaps, regulatory requirements, and commercialization goals.
  • Evaluate emerging technologies in digital health, remote monitoring, AI/ML diagnostics, and edge computing.
• Medical Device Software Architecture:
  • Oversee architecture for cloud‑connected device platforms and supporting mobile and web applications.
  • Ensure interoperability with HL7, FHIR, DICOM where applicable.
  • Establish secure device‑to‑cloud communication architectures.
  • Define cybersecurity‑by‑design frameworks aligned with FDA and global guidance.
• Regulatory & Compliance Leadership:
  • Ensure compliance with FDA 21 CFR Part 820/Part 11, ISO 13485, IEC 62304, ISO 14971, GDPR/HIPAA where applicable.
  • Oversee Design Controls, Verification & Validation and documentation processes.
  • Lead software risk management and hazard analysis activities.
  • Support regulatory submissions (510(k), CE marking, etc.) from a software perspective.
• Engineering Execution & Quality:
  • Lead cross‑functional engineering teams including software, firmware, systems, DevOps, QA.
  • Implement secure software development lifecycle (SSDLC) practices.
  • Establish CI/CD pipelines suitable for regulated environments.
  • Drive system reliability, performance, and traceability across the product lifecycle.
  • Oversee technical documentation and audit readiness.
• Organizational Leadership & Talent Development:
  • Build and scale high‑performing engineering and architecture teams.
  • Mentor engineering leaders and principal architects.
  • Establish engineering KPIs aligned with product quality and compliance.
  • Foster a culture of accountability, innovation, and regulatory excellence.
• Executive & Cross‑Functional Collaboration:
  • Partner with Regulatory Affairs, Quality, Clinical, Product, and Manufacturing teams.
  • Translate technical architecture into regulatory and business impact for executives.
  • Participate in customer, auditor, and regulatory agency engagements.
  • Support M&A technical due diligence when applicable.

Required Qualifications

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, or related field.
• 12–15 years of progressive software engineering experience, with 5+ years in senior leadership roles in medical devices or regulated healthcare technology.
• Deep expertise in IEC 62304‑compliant software development.
• Experience with connected medical devices and cloud architecture (AWS, Azure, or GCP).
• Strong understanding of regulatory audits and submissions.
• Proven experience leading multidisciplinary engineering teams.

Preferred Qualifications

• Experience with Software as a Medical Device (SaMD).
• Familiarity with AI/ML in regulated healthcare products.
• Experience with cybersecurity standards (FDA guidance, NIST).
• Knowledge of interoperability standards (HL7, FHIR, DICOM).
• Cloud or medical device quality certifications.
• Experience in global regulatory environments (FDA, EU MDR, Health Canada, etc.).

Benefits & Compensation

• Competitive salary range $144,541–$216,812 per year with potential for annual bonus.
• 401(k) with company match.
• Comprehensive medical, dental, vision coverage effective on start date.
• 24/7 Employee Assistance Program.
• Free live and on‑demand Wellbeing Programs.
• Generous paid vacation, sick time, parental leave, and adoption assistance.
• 12 paid holidays.
• On‑site child daycare, café, fitness center (where applicable).

EEO & Accommodation Statement

Olympus is an equal‑employment opportunity employer. We are committed to providing reasonable accommodations for applicants with disabilities. Please contact [e-mail] or call 1‑888‑659‑6787 for assistance.