The purpose of the DEP position is to design and development of medical device packaging or sterilization cases. Includes qualification/testing of packaging configurations and process validation.
Duties and Responsibilities (Key Deliverables):
Under supervision, 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). These design inputs should take into consideration function, reliability, cost and company image.
Prepare specifications for the raw materials, components and processes for medical-device packaging or sterilization case components.
(For Packaging Engineer) Execute test protocols for medical-device packaging or sterilization cases components.
(For Case Engineer) Perform cleaning and sterilization assessments of new and modified instruments, nonsterile implants, and/or sterilization cases.
(For Case Engineer) Working with an outside laboratory, coordinate cleaning and/or sterilization testing as needed for instruments, implants, and sterilization case systems.
(For Packaging Engineer) 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.
Assure timely and effective project completion according to the project plan and budget.
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.
Participate in the establishment of goals, project plans and resource requirements.
Identify, analyze and recommend new technologies or materials for specific applications.
Define and execute product testing and validation protocols.
Recommend project priorities based on perceived market needs.
Contribute to the timely and accurate completion of the projects and tasks assigned to his/her team.
Know and apply the Quality System and any appropriate Federal and International standards.
Assist and support other employees, teams, and sales personnel as necessary.
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/case manufacturing and inspection methods/processes, FDA/ISO requirements, project management, orthopedic implants and/or instruments and the materials and methods used in their packaging or sterilization cases.
• Must have knowledge of various software packages including Microsoft Office applications. Knowledge of CAD applications is preferred.
Bachelors or better.
Basic understanding of theoretical technical principles in the following areas: mechanical drafting, geometrical dimensioning and tolerancing, computer aided design, statistics, basic packaging methods, packaging evaluation, packaging materials, and technical writing.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)