Systems Engineering Principal Engineer

Kelly Services; Raynham (MA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical & Dental

401K plan

Paid time off

Job summary

Kelly Engineering in Raynham, MA is hiring a Systems Engineering Principal Engineer to support global Hip and Knee R&D programs on a long‑term contract. The role focuses on translating clinical and regulatory needs into system requirements, architecture decisions, and verification strategies across cross-functional teams.

As a mid‑level contributor, you will partner with program leaders, senior engineers, and suppliers to drive design control, risk assessments, and lifecycle management, while

Qualifications

• Experience in medical device product development and systems engineering.
• Knowledge of design controls and regulatory standards.
• Experience with cross-functional teams across R&D, quality, regulatory.
• Ability to translate needs into clear, testable requirements.

Responsibilities

• Develop, maintain, and communicate system-level requirements across programs.
• Translate clinical and regulatory needs into actionable technical requirements.
• Lead or contribute to system-level hazard analysis and risk assessments.
• Review test strategies, verification plans, and documentation for compliance.
• Mentor junior engineers and coordinate cross-functional teams.

Skills

Systems engineering

Requirements management

Cross-functional teamwork

Regulatory knowledge

Education

Bachelor's degree in engineering

Advanced degree preferred

Job description

Systems Engineering Principal Engineer: Kelly Engineering is hiring a Systems Engineering Principal Engineer for a long-term contract with one of our Global Medical Device clients, located in Raynham, MA. This is a global, mid-level individual contributor role within Hip and Knee R&D Orthopaedics. The role may support new product development, platform extensions, sustaining engineering, product remediation, lifecycle management, and cross-platform systems engineering initiatives. The position will work closely with program leaders and senior technical experts and may provide technical guidance to engineers, project teams, and external partners.

This role is a full-time, fully benefited position. As a Kelly employee, you will be eligible for Medical & Dental, a 401K plan, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time. All Kelly employees receive annual performance reviews.

The Systems Engineering Principal Engineer will support global Hip and Knee R&D programs by applying systems engineering methods to complex orthopaedic 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.

Key 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 orthopaedic 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 Orthopaedics, 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.

Core Competencies

• Systems thinking: Sees the full product, procedure, stakeholder, and lifecycle context; anticipates downstream impacts of technical decisions.
• Requirements discipline: Creates clear, measurable, testable, and traceable requirements that support efficient development and compliance.
• Cross-functional leadership: Builds alignment across technical and non-technical stakeholders without relying on formal authority.
• Risk-based decision-making: Integrates patient safety, clinical performance, regulatory expectations, manufacturability, and business constraints into recommendations.
• Technical communication: Communicates complex system-level topics clearly through written documentation, visual models, reviews, and executive-ready summaries.
• Continuous improvement: Identifies opportunities to improve tools, templates, governance, and ways of working across global Hip and Knee R&D programs.

Success Measures

• System requirements are complete, testable, traceable, and aligned with stakeholder needs and program objectives.
• Architecture, interface, and design trade-off decisions are documented clearly and supported by appropriate evidence.
• Verification and validation strategies are risk-based, efficient, and aligned with design inputs and intended use.
• Cross-functional teams have clear alignment on system-level expectations, risks, assumptions, and decision rationale.
• Design control deliverables are completed with high quality, on schedule, and in compliance with applicable procedures and standards.
• Systems engineering practices are adopted consistently across Hip and Knee R&D programs and contribute to improved execution quality.

Important information

Applicants must be legally permitted to work in the United States immediately and without employer sponsorship