Post Market Surveillance Engineer

Advita Ortho, LLC; Gainesville (FL); On-site; USD 70,000 - 100,000; Full time

Job summary

Advita Ortho, LLC is seeking a quality investigation engineer in Gainesville, FL to perform complaint product analysis and root cause investigations in support of regulatory requirements and product improvement.

The role involves collaborating with cross-functional engineering teams, documenting activities, and supporting audits, CAPAs, and quality processes as part of continuous improvement of orthopedic implants and instruments.

Qualifications

• Bachelor’s degree in an Engineering discipline from an accredited institution required; Mechanical or Biomedical Engineering preferred.
• Basic understanding of mechanical drafting, GD&T, computer aided design, engineering statics and dynamics, mechanics of materials, mechanical design, root cause and risk analysis, and technical writing.

Responsibilities

• Applies engineering problem-solving techniques during complaint investigations.
• Performs complaint product analysis and testing per procedures.
• Performs root cause analysis and risk analysis for complaints.
• Supports CAPAs, HHEs, NCRs and other quality processes as needed.
• Drafts investigation responses to customers and assists in procedures/documents.

Skills

Problem solving

Root cause analysis

Technical writing

Cross-functional collaboration

Attention to detail

Time management

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Tools

CAD

Microsoft Office

Job description

Description

Performs complaint product analysis and root cause investigation in support of Advita and regulatory requirements, product improvement, and issue escalation.

Performs complaint product analysis and root cause investigation in support of Advita and regulatory requirements, product improvement, and issue escalation.

Department: Quality

Location: Gainesville, FL

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.