Principal Systems Engineer – Medical Devices (Polarion ALM)

Iconma

Cincinnati, OH
10 days ago

$35.71 Per Hour

Highlights

Polarion-native capability, including hands-on experience developing, structuring, managing, and maintaining requirements, traceability, reviews, baselines, and change impact assessments within Polarion. 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.

Numbers & Facts

Location	Cincinnati, OH
Industry	Management Consulting Services
Salary	$35.71 Per Hour
Company Size	2,000 to 2,499 employees
Year Founded	2000
Website	https://www.iconma.com/

Description

Our Client, an IT Services and Consultant company, is looking for a Principal Systems Engineer – Medical Devices (Polarion ALM) for their Cincinnati, OH location.

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.

Requirements:

Polarion Expertise
Medical Device Design Controls,
Systems Engineering & Requirements Management
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.
Manufacturing locations, labs, customer engagements, or professional meetings as needed.
Years of Experience: 10.00 Years of Experience

Why Should You Apply?

Excellent growth and advancement opportunities

Benefits

401K, Employee Referral Program, Life Insurance

About Company

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
Founded in 2000
2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.