Senior Systems Engineer, Hip & Knee R&D

Belcan Corporation; Cincinnati (OH); On-site; USD 143,270,000 - 171,924,000; Full time

Job summary

The Systems Engineering Principal Engineer will support global Hip and Knee R&D programs by applying systems engineering methods to complex orthopedic implant, instrument, and enabling technology development.

This mid-level role will translate clinical, customer, regulatory, quality, and business needs into clear system requirements, architecture decisions, verification strategies, and cross-functional technical alignment.

Qualifications

• Bachelor's degree in Mechanical, Biomedical or Systems Engineering; advanced degree preferred.
• 5–10 years in medical device product development or related field.
• Experience with regulated medical device development, design controls & risk management.
• Knowledge of ISO 13485, ISO 14971, FDA QMS and global documentation practices.
• Ability to translate clinical or customer needs into testable, traceable requirements.
• Polarion experience with requirements, traceability, reviews and change impact.
• Experience collaborating across R&D, quality, regulatory, manufacturing and partners.
• Strong analytical, communication, and facilitation skills; able to influence without authority.
• Willingness to travel across global teams and sites as needed.

Responsibilities

• Develop and maintain system-level requirements in Polarion with traceability from user needs to design outputs.
• Translate system needs into clear requirements and alignment points for cross-functional teams.
• Support design control activities: requirements management, risk management, reviews, verification planning.
• Translate surgeon/regulatory needs into actionable technical requirements for orthopedic solutions.
• Lead or contribute to hazard analysis, risk assessment, and risk verification with quality and regulatory teams.
• Develop and review test strategies, acceptance criteria, and technical justification for verification.
• Facilitate technical decisions, document assumptions, assess risks, and align stakeholders.
• Ensure consistency of requirements, architecture and verification across regions and lifecycle phases.
• Mentor junior engineers and drive continuous improvement of systems engineering practices.

Skills

Systems engineering

Cross-functional collaboration

Requirements management

Traceability

Analytical thinking

Communication

Facilitation

Problem solving

Education

Bachelor's degree in Mechanical Engineering

Tools

Polarion

Job description

The Systems Engineering Principal Engineer will support global Hip and Knee R&D programs by applying systems engineering methods to complex orthopedic implant, instrument, and enabling technology development.

This mid-level role will translate clinical, customer, regulatory, quality, and business needs into clear system requirements, architecture decisions, verification strategies, and cross-functional technical alignment.