Sr. Principal Engineer - Johnson & Johnson

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

Description

Job Title: Sr. Principal Engineer - Hip & Knee R&D

Pay Rate: $50-60/hr

Duration: 24-month contract

Location: Cincinnati, OH

Zip Code: 45242

Start Date: Right Away

Keywords: #SystemsEngineerJobs

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 help translate clinical, customer, regulatory, quality, and business needs into clear system requirements, architecture decisions, verification strategies, and cross-functional technical alignment. The role is intended for an engineer who can operate independently on defined workstreams while partnering closely with senior technical leaders, product development teams, quality, regulatory, clinical, manufacturing, and commercial stakeholders.

Responsibilities

• Develop, write, maintain, and communicate system-level requirements for Hip and Knee R&D programs in Polarion, ensuring traceability from user needs through design inputs, verification, validation, and design outputs.
• Serve as a requirements liaison across implants, instrumentation, and digital enablement by translating system needs, interface expectations, and workflow dependencies into clear requirements and alignment points for cross-functional teams.
• Support design control activities, including requirements management, risk management, design reviews, verification and validation planning, change impact assessment, and design history documentation.
• Translate surgeon, patient, hospital, commercial, and regulatory needs into actionable technical requirements that support safe, effective, manufacturable, and globally scalable orthopedic solutions.
• Lead or contribute to system-level hazard analysis, use-related risk assessment, failure mode evaluation, and risk control verification in partnership with quality, clinical, human factors, and regulatory teams.
• Develop and review test strategies, protocols, acceptance criteria, and technical rationale for system, subsystem, and interface verification.
• Facilitate technical decision-making by framing options, documenting assumptions, assessing risks, and aligning stakeholders around evidence-based recommendations.
• Support global product development teams by ensuring requirements, architecture, and verification strategies are consistent across regions, platforms, and lifecycle phases.
• Contribute to continuous improvement of systems engineering practices, templates, tools, requirements repositories, and cross-platform standards for Hip and Knee R&D.
• Mentor junior engineers and cross-functional partners on systems thinking, requirements quality, traceability, and structured problem solving.

Required Qualifications

• Bachelor"s degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, Materials Science, or a related technical discipline; advanced degree preferred.
• 5-10 years of experience in medical device product development, systems engineering, design engineering, R&D, or a closely related technical role.
• Experience working within regulated medical device development processes, including design controls, requirements management, risk management, verification, validation, and technical documentation.
• Working knowledge of medical device quality and regulatory expectations, including ISO 13485, ISO 14971, FDA Quality Management System requirements, and global product development documentation practices.
• Demonstrated ability to translate clinical or customer needs into clear, testable, traceable system and subsystem requirements.
• Polarion-native capability, including hands‑on experience developing, structuring, managing, and maintaining requirements, traceability, reviews, baselines, and change impact assessments within Polarion.
• Experience collaborating with multidisciplinary teams across R&D, quality, regulatory, clinical, manufacturing, supply chain, marketing, and external partners. Experience with Project management inputs to develop program plans.
• Strong analytical, problem‑solving, communication, and facilitation skills, with the ability to influence without direct authority.
• Ability to work across global teams and time zones, with occasional travel to R&D sites, manufacturing locations, labs, customer engagements, or professional meetings as needed.

Preferred Qualifications

• Experience in Orthopedics, Joint Reconstruction – Hip, Knee, Robotics, digital surgery, surgical planning, navigation, or implantable medical devices.
• Familiarity with hip or knee anatomy, biomechanics, implant systems, surgical instruments, surgical workflow, and clinical performance considerations.
• Experience supporting global product launches, line extensions, sustaining engineering, remediation, or portfolio‑level platform strategy.
• Understanding of human factors engineering, usability engineering, design for manufacturability, design for assembly, and supplier interface management.
• Systems engineering certification, INCOSE training, Six Sigma, Design for Six Sigma, or equivalent structured problem‑solving experience.

Work Environment

This role operates in a global R&D environment and requires collaboration across regions, functions, platforms, and lifecycle phases. The position may support new product development, platform extensions, sustaining engineering, remediation, lifecycle management, and cross‑platform systems engineering initiatives.

Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.