Senior Hardware Platform Manager, Medical COTS & Lifecycle

Olympus Corporation; Boston (MA); Hybrid; USD 138,000 - 193,000; Full time

Benefits offered by this job

Salary bonus & 401(k)

Medical/dental/vision

Employee assistance

Wellbeing programs

Paid time off

Parental leave

Holidays

On-site facilities

Job summary

Olympus Corporation in Westborough, MA, is seeking a Senior Hardware Engineering Manager to lead the OLYSENSE Hub Platform hardware team. This role emphasizes hardware architecture, COTS integration, reliability, lifecycle management, and cross‑functional execution with Software, AI, Quality, Regulatory, and Suppliers.

You will mentor a team of ~5–6 engineers, manage platform roadmap, and ensure compliance with IEC safety standards while driving manufacturability and serviceability across the

Qualifications

• 10+ years in hardware engineering or regulated hardware development.
• 5+ years in engineering leadership or people management.
• Experience integrating COTS/embedded computing platforms into production products.
• Experience with IEC 60601‑1/1‑2 and IEC 62368‑1 and related safety standards.
• Strong cross‑functional leadership and program management.

Responsibilities

• Lead hardware engineering strategy and planning for the OLYSENSE Hub platform, including budget, capacity, resources, infrastructure, laboratory capabilities, external engineering support, prototype builds, test equipment, suppliers, and production transfer needs.
• Build, lead, mentor, and develop the Hardware Platform and Systems Integration Engineering team, ensuring effective resource utilization, technical capability development, performance management, and alignment with Olympus business and product objectives.
• Provide technical leadership and accountability for hardware engineering deliverables, including architecture, component selection, interface specifications, verification inputs, test plans, design documentation, manufacturing transfer, lifecycle records, and technical contributions to the Design History File.
• Own the OLYSENSE Hub hardware platform roadmap and lifecycle strategy, including technology refresh, scalability, component obsolescence, alternate sourcing, end‑of‑life planning, platform consolidation, upgrades, and long‑term platform sustainability.
• Lead cross‑functional product development, production transfer, and lifecycle sustainment, partnering with Software, AI, Systems Engineering, Product Management, Quality, Regulatory, Operations, Purchasing, Suppliers, Contract Manufacturers, Service, and external laboratories to ensure product readiness, compatibility, reliability, manufacturability, and serviceability.
• Drive hardware reliability and continuous improvement, using field data, failure data, manufacturing metrics, supplier performance, customer feedback, complaints, CAPA, post‑market surveillance, and service data to address issues, reduce service burden, and improve platform robustness.
• Define and maintain electrical safety and EMC compliance strategy for the OLYSENSE Hub platform, applying applicable standards including IEC 60601‑1, IEC 60601‑1‑2, IEC 62368‑1:2023, and regional requirements. Coordinate external laboratory testing, test configurations, acceptance criteria, issue resolution, and supporting technical documentation.
• Develop hardware engineering capabilities, infrastructure, and external partnerships, including laboratory and test capabilities, prototype configuration management, supplier/OEM relationships, contract manufacturing interfaces, external engineering partners, and test laboratories required to support development, qualification, production, troubleshooting, and lifecycle management.
• Ensure execution within the Olympus Quality Management System and drive engineering efficiency, including compliance with design control and change management requirements and standardization of components, interfaces, design reviews, test planning, supplier engagement, lifecycle documentation, and technical decision‑making.

Skills

Hardware architecture

COTS/embedded computing

Electrical safety & EMC

Leadership & mentorship

Systems integration

Lifecycle management

Cross-functional leadership

Budget & planning

Problem solving

Education

Bachelor’s degree in Electrical Engineering or related

Master’s degree in Biomedical/ Electrical Engineering or related

Job description

Olympus Corporation in Westborough, MA, is seeking a Senior Hardware Engineering Manager to lead the OLYSENSE Hub Platform hardware team. This role emphasizes hardware architecture, COTS integration, reliability, lifecycle management, and cross‑functional execution with Software, AI, Quality, Regulatory, and Suppliers.

You will mentor a team of ~5–6 engineers, manage platform roadmap, and ensure compliance with IEC safety standards while driving manufacturability and serviceability across the