Job Description

Post Market Engineer - Medical Devices

JOB-10044049

Anticipated Start Date

May 19, 2025

Location

Gainesville, FL

Type of Employment

Contract Hire

Employer Info

Our client develops, manufactures, markets, distributes, and sells orthopedic implant devices, related surgical instrumentation, and biologic services. Many of the roles are temp to hire with our client. All of their buildings are air-conditioned and a comfortable work environment. 

Job Summary

We are looking for a Post Market Engineer to join our team.  This role is responsible for performing complaint product analysis and root cause investigations in accordance with regulatory and quality system requirements. The position plays a critical role in ensuring product safety, compliance, and continuous improvement by analyzing product complaints and contributing to regulatory reporting processes.

Job Description

• Apply sound engineering problem-solving techniques during complaint investigation activities.
• Perform product analysis and testing related to field complaints, following internal procedures and regulatory requirements.
• Conduct root cause investigations and support findings with objective evidence and sound rationale.
• Perform complaint risk assessments and review product complaint histories.
• Escalate findings in line with internal protocols and based on investigation outcomes.
• Document all investigation activities, including complaint coding and escalation steps, in accordance with company procedures.
• Coordinate the initiation of new complaints and regulatory reporting as determined during investigation.
• Support timely completion of complaint-related tasks aligned with departmental metrics and KPIs.
• Maintain up-to-date knowledge of Quality System requirements and applicable FDA and international standards.
• Provide assistance with other complaint handling processes as needed.

Skills Required

• Proven understanding of root cause analysis, risk assessment, and technical writing.
• Previous experience in an FDA-regulated environment, preferably within the medical device or pharmaceutical industry.
• Familiarity with FDA and ISO quality management system regulations.
• Excellent verbal and written communication skills.
• Strong interpersonal skills with the ability to work collaboratively in a team environment.
• Exceptional attention to detail and accuracy in documentation and analysis.
• Strong organizational and time management capabilities.
• Self-motivated with the ability to manage priorities and meet deadlines independently.
• Proficiency in Microsoft Office and other relevant software tools.

Education

• Bachelor’s Degree in an Engineering discipline from an accredited institution is required.

Additional Requirements

• Direct experience in product complaint investigation and handling is highly desirable.

Pay Rate

• $100 per hour and higher depending on experience

We are an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

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