PM Surveillance Engineer Department: Quality Employment Type: Full Time Location: Gainesville, FL Reporting To: Director, Post Market Surveillance Description Performs complaint product analysis and root cause investigat…
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Full-time
bachelor degree, postgraduate degree
Posted 14h ago
~40 hrs/week
Responsibilities
The PM Surveillance Engineer performs complaint product analysis, root cause investigations, and risk assessments to support product improvement and regulatory compliance. They collaborate with cross-functional teams to document findings and ensure all activities align with quality system procedures and department metrics.
Requirements
Candidates must hold a Bachelor’s degree in an Engineering discipline, with a preference for Mechanical or Biomedical Engineering. Previous experience in an FDA-regulated medical device or pharmaceutical environment is preferred, along with strong technical writing and problem-solving skills.
Full job description
PM Surveillance Engineer
Department: Quality
Employment Type: Full Time
Location: Gainesville, FL
Reporting To: Director, Post Market Surveillance
Description
Performs complaint product analysis and root cause investigation in support of Advita and regulatory requirements, product improvement, and issue escalation.
Key Responsibilities
Applies sound engineering problem-solving techniques during complaint investigation activities.
Performs complaint product analysis and testing per Advita's procedures and requirements.
Performs complaint root cause analysis.
Performs complaint risk analysis and complaint history reviews.
Escalates complaint investigation findings, as appropriate and per Advita's procedures and requirements.
Collaborates with cross-functional engineering teams to ensure thorough investigations and appropriate escalations.
Documents all complaint investigation and escalation activities per Advita's procedures and requirements.
Provides design, engineering, and analysis support to other engineers and designers in the maintenance of orthopedic implants and instruments currently on the market as part of continuous improvement.
Supports CAPAs, HHEs, NCRs, and other quality processes, as needed.
Supports the completion of complaint activities in line with department metrics and key performance indicators.
Supports audits and audit requests for complaints.
Drafts investigation responses to customers, as requested.
Supports the drafting and revision of procedures, work instructions, forms, technical documents, and protocols.
Supports continuous improvement activities.
Assists in training complaint team members.
Know and applying Advita’s Quality System and any appropriate FDA and international standards.
Assist and support other employees, teams, and sales personnel as necessary.
Skills Knowledge and Expertise
Education:
Bachelor’s Degree in an Engineering discipline from an accredited institution required; degree in Mechanical or Biomedical Engineering, or a Master’s Degree preferred.
Experience:
Must have a basic understanding of theoretical technical principles in the following areas: mechanical drafting, geometrical dimensioning and tolerancing, computer aided design, engineering statics and dynamics, mechanics of materials, mechanical engineering design, root cause and risk analysis, and technical writing.
Previous experience in the Medical Device or Pharmaceutical FDA regulated environment preferred.
Experience with FDA/ISO quality management system regulations preferred.
Functional/Technical Knowledge, Skills and Abilities Required:
Must have excellent communication (verbal & written) and organizational skills.
Must have excellent interpersonal skills and must be able to work effectively in a team environment.
Must be detail-oriented and have the ability to consistently meet high standards of input accuracy, produce quality documents, compile data, and perform analyses with accuracy.
Strong organizational and time management skills.
Self-directed; capable of setting own priorities and working independently to meet established deadlines.
Must be creative and have the ability to independently apply theoretical technical principles to product design.
Must have knowledge of various software packages including Microsoft Office applications.
To fully meet team responsibilities, the individual will develop additional knowledge and skills in anatomy and physiology, especially as related to the musculo-skeletal system, fundamentals of orthopedic surgery (major joints), mechanical test methods and procedures, quality and inspection methods, manufacturing processes and methods, FDA/ISO requirements, project management, orthopedic implants and the materials used in orthopedic implants and instruments.
Related keywords
Post Market SurveillanceQuality SystemFDAISOCAPAHHENCRMechanical EngineeringBiomedical EngineeringOrthopedic ImplantsRoot Cause AnalysisRisk AnalysisTechnical WritingCADGD&TCompliance
Advita Ortho is a global medical device company committed to advancing patient lives through innovative orthopedic solutions. We specialize in high-quality implants and a comprehensive suite of integrated surgical technologies that are powered by data, artificial intelligence and machine learning. Offering trusted leadership and clinical expertise, Advita Ortho is uniquely positioned to advance mobility and improve lives worldwide. Learn more at advita.com.
Offices: 2320 Northwest 66 Court, Gainesville, Florida 32653, US
How many Science & Research jobs are open in Gainesville, FL right now?
There are currently 289 open science & research positions in Gainesville, FL listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in Gainesville, FL?
Companies currently hiring include UF Health, LifeSouth Community Blood Centers, Santa Fe College Business Programs, Florida Cancer Specialists & Research Institute, Florida Department of Agriculture and Consumer Services, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in Gainesville, FL?
Yes — 9 of the 289 open science & research positions offer remote or hybrid work (5 remote, 4 hybrid).
How do I apply for Science & Research jobs in Gainesville, FL?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.