Sustaining Engineer Jobs

Department: Engineering, Core

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Kenny King

Description

Provide design, engineering, and analysis support to other engineers and designers in the maintenance of orthopedic implants and instruments currently on the market.

Key Responsibilities

• Prepare and submit written and oral communications that describe product design concepts, attributes and performance and project status. Areas of involvement include regulatory submissions, design history files, device evaluation and testing, manufacturing or supplier support, quality control, packaging, operating room support, device complaint evaluation, patent disclosures and instrument refurbishment.
• Regulatory compliance
• Process enhancement and improvement
• Establish appropriate project plan (i.e. define tasks, dependencies, schedule and resource requirements).
• Product design verification and design validation
• Test methods and tooling design
• Lead a cross-functional project team (including both internal and external team members such as orthopedic surgeons) of one or several minor maintenance projects. A minor project involves the modification, adaptation or extension of an existing product or product line.
• Design changes
• Non-conformance investigation and root cause analysis
• CAPA resolution
• Know and apply the Quality System and any appropriate Federal and International standards.
• Study and recommend improvements to existing products and processes. This entails staying "up to date" on emerging material and medical product technologies. This may be accomplished by attending seminars, classes and industry meetings. Contribute to the timely and accurate completion of the projects and tasks assigned to his/her team.
• Apply sound engineering problem-solving techniques to product improvement and maintenance tasks including design, analysis, material selection, inspection requirements and manufacturing process requirements.
• Maintain product performance and quality by assisting with issues relating to CAPAs, customer complaints and manufacturing processes, such as:
• Define and execute product testing and validation protocols.
• Provide 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.
• Assist and support other employees, teams, and sales personnel as necessary.
• Complete and approve all Design History File documentation for assigned projects as required.

Skills Knowledge And Expertise

Education:

• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or equivalent from an accredited institution required; 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, materials, and technical writing.

Functional/Technical Knowledge, Skills and Abilities Required:

• 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.
• Must have the ability to apply parametric solid modeling and drafting conventions to design projects.
• Must be creative and have the ability to independently apply theoretical technical principles to product design.
• Must have excellent interpersonal skills and must be able to work effectively in a team environment.
• Must have knowledge of various software packages including Microsoft Office applications and CAD applications.
• Must have excellent communication (verbal & written) and organizational skills.
• Travel 5-10%