Sr. Development Engineer Packaging

Description

Design and development of medical device packaging or sterilization cases. Includes qualification / testing of packaging configurations and process validation.

Key Responsibilities

• With direction, design and develop package or sterilization case components for new or existing products.
• Define the design input requirements for medical-device packaging or sterilization case components through consultation with end users and other stakeholders (e.

g, nurses, Sales, Marketing, Development, Quality, Manufacturing and Distribution personnel).

Prepare specifications for the raw materials, components and processes for medical-device packaging or sterilization case components.

For Packaging Engineer) Define and execute test protocols and reports for medical-device packaging performance testing and shelf life.

• Define and document sterile product bills of material and shelf life.
• Establish appropriate project plan (i.e. define tasks, dependencies, schedule and resource requirements).
• Complete all Design Control activities for projects as required.
• Maintain and improve existing packaging or sterilization case systems.
• Apply sound engineering problem-solving techniques to package / case development and maintenance tasks including design, statistical analysis, material selection, inspection requirements and manufacturing process requirements.
• Prepare and submit written and oral communications that describe package / case design concepts, attributes and performance, and project status.

Areas of involvement include regulatory submissions, Design History Files, package / case evaluation, package / case validation and testing, manufacturing or supplier support, quality control and complaint evaluation.

• Consult with vendors, as required, regarding the technical aspects of design and development projects.
• Lead the project team of one major and several minor projects.
• Review designs for feasibility and accuracy.
• Approve drawings and specifications.
• Procure and evaluate prototypes.
• Assist in the resolution of manufacturing- or quality-related issues.
• Study and recommend improvements to existing packaging and processes or case systems. This entails staying up to date on emerging material and sterilization technologies.

This may be accomplished by attending seminars, classes and industry meetings.

• Perform package / case evaluations.
• Define and execute product testing and validation protocols.
• Identify, analyze and recommend new technologies or materials for specific applications.
• Know and apply the Quality System and any appropriate Federal and International standards.

Skills, Knowledge & Expertise

Education :

Bachelor’s Degree from an accredited institution required; Master's Degree preferred

Experience :

Minimum of 7 years of full-time medical device packaging or sterilization case development experience. This experience shall be in addition to any college internships.

Relevant product development experience in other areas may be considered.

Must have a basic understanding of theoretical technical principles in the following areas : mechanical drafting, geometrical dimensioning and tolerancing, computer aided design, statistics, basic packaging and / or sterilization methods, packaging / case evaluation, packaging / case materials, and technical writing.

Functional / Technical Knowledge, Skills and Abilities Required :

• Must have a practical working knowledge of medical-device packaging or sterilization case systems, packaging / case evaluation techniques / methods, engineering drawing interpretation, packaging manufacturing and inspection methods / processes, FDA / ISO requirements, project management, orthopedic implants and / or instruments and materials and methods used in their packaging or sterilization cases.
• Must have the ability to apply parametric solid modeling and drafting conventions to design projects.
• Must have knowledge of various software packages including Microsoft Office applications and CAD applications.
• Travel 5-10%

About Exactech

Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians.

Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific.

Visit www.exac.com for more information and connect with us on LinkedIn , VuMedi , YouTube , Twitter and Instagram .