Sr. Development Engineer Packaging
3 weeks ago
Department: Manufacturing Engineering
Employment Type: Full Time
Location: Gainesville, FL
Reporting To: Manager Packaging & End of Line Engineering
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.
Education:
- Bachelor's Degree from an accredited institution required; Master's Degree preferred
- 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.
- 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%
-
Sr. Development Engineer Packaging
1 month ago
Gainesville, United States Exactech Full timeJob DescriptionJob DescriptionDescriptionDesign and development of medical device packaging or sterilization cases. Includes qualification/testing of packaging configurations and process validation.Key ResponsibilitiesWith direction, design and develop package or sterilization case components for new or existing products.Define the design input requirements...
-
Sr. Validation Engineer
3 weeks ago
Gainesville, United States Exactech Full timeSr. Validation EngineerDepartment: Manufacturing Engineering Employment Type: Full Time Location: Gainesville, FL Reporting To: Norbert Nasi Description The Sr Validation Engineer, QA provides cross-functional support in V&V development, planning and execution while maintaining corporate engineering and quality systems best practices, policies and...
-
Sr. Validation Engineer
1 month ago
Gainesville, United States Exactech Full timeJob DescriptionJob DescriptionDescriptionThe Sr Validation Engineer, QA provides cross-functional support in V&V development, planning and execution while maintaining corporate engineering and quality systems best practices, policies and procedures. The Sr Validation Engineer, QA is results oriented and has the knowledge and confidence in the areas of...
-
Packaging Engineer
1 month ago
Gainesville, United States Exactech Full timeJob DescriptionJob DescriptionDescriptionDesign and development of medical device packaging or sterilization cases. Includes qualification/testing of packaging configurations and process validation.Key ResponsibilitiesUnder supervision, design and develop package or sterilization case components for new or existing products.Define the design input...
-
Sr. Supplier Development Engineer
3 months ago
Gainesville, United States Fox Factory Full timePosition Summary:Coordinate development activities across multiple suppliers. Coordinate, validate, and analyze all Supplier Launch PPAP documentation. Troubleshoot supplier quality issues. Work with suppliers to drive cost reduction and quality improvement efforts. Position Responsibilities:Coordinate with project team in US to ensure suppliers meet...
-
Sr. Supplier Development Engineer
3 months ago
Gainesville, United States Fox Factory Full timePosition Summary:Coordinate development activities across multiple suppliers. Coordinate, validate, and analyze all Supplier Launch PPAP documentation. Troubleshoot supplier quality issues. Work with suppliers to drive cost reduction and quality improvement efforts. Position Responsibilities:Coordinate with project team in US to ensure suppliers meet...
-
Sr. Validation Engineer
1 week ago
Gainesville, United States Exactech Full timeDescriptionThe Sr Validation Engineer, QA provides cross-functional support in V&V development, planning and execution while maintaining corporate engineering and quality systems best practices, policies and procedures. The Sr Validation Engineer, QA is results oriented and has the knowledge and confidence in the areas of Quality Assurance and...
-
Upstream Process Development Engineer
23 hours ago
Gainesville, Florida, United States Ascend Advanced Therapies Full timeJob SummaryWe are seeking a highly skilled Senior Process Development and Manufacturing Engineer to join our team at Ascend Advanced Therapies. As a key member of our Process Development and Manufacturing department, you will be responsible for leading the development and optimization of upstream process unit operations for the production of gene...
-
Systems and Development Engineering
2 weeks ago
Gainesville, FL, United States Amazon Development Center U.S., Inc. Full timeWould you enjoy diving deep into, operating, and improving some of the largest software systems humanity has ever built? Do the challenges that come of driving technical, business, and cultural change to improve the reliability, performance, and efficiency excite you? The AWS Managed Operations (MO) organization was founded in April 2023, with the objective...
-
Sr BOA
1 month ago
Gainesville, United States Edward Jones Full timeWould you call yourself a relationship builder, a problem solver or a critical thinker? If you answered yes, we need you on our team.At Edward Jones, we are very intentional in calling our field associates branch teams. Most of our teams are two or three people, and in a Branch Office Support Professional role, you are a critical member of that team along...
-
Software Development Engineer
6 days ago
Gainesville, Florida, United States Innova Solutions Full timeJob SummaryInnova Solutions is seeking a highly skilled Software Development Engineer to join our team. As a key member of our organization, you will be responsible for designing, developing, and deploying complex software systems and applications.Key ResponsibilitiesDesign and develop software applications using various programming languages and...
-
Sr. Clinical Specialist
3 months ago
Gainesville, United States Abbott Full timeThe Opportunity In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides advanced engineering, sales,...
-
Packaging Supervisor
3 months ago
Gainesville, United States Exactech Full timeJob DescriptionJob DescriptionDescriptionTo provide leadership and support to direct reports within Packaging that creates an engaging environment that inspires teammates to go above and beyond to meet customer need. Key ResponsibilitiesResponsible for maintaining a safe and well-ordered workplace, identifying and resolving safety issues within the...
-
Gainesville, FL, United States Amazon Development Center U.S., Inc. Full timeWould you enjoy diving deep into, operating, and improving some of the largest software systems humanity has ever built? Do the challenges that come of driving technical, business, and cultural change to improve the reliability, performance, and efficiency excite you? The AWS Managed Operations (MO) organization was founded in April 2023, with the objective...
-
Gainesville, VA, United States Amazon Development Center U.S., Inc. Full timeAre you passionate about leading a high-impact systems development and operations team? This role is responsible for leading a team accountable for the operational performance, customer experience, maintenance, security, and functional parity of Builder Tools in US Amazon Dedicated Cloud (ADC) regions. The ADC aligned team, Pyxis, supports Builder Tools...
-
Test Design Engineer
4 weeks ago
Gainesville, United States Exactech Full timeTest Design Engineer Department: Engineering, Core Employment Type: Full Time Location: Gainesville, FL Reporting To: Director E&D Description To provide design, engineering, testing and analysis support to other engineers and designers in the development and maintenance of orthopedic implants and instruments. Key Responsibilities Provide design,...
-
Sr. Specialized Customer Service
3 months ago
Gainesville, United States Vector Security Full time** Sr. Specialized Customer Service** **Job Category****:** Operations Support **Requisition Number****:** SRSPE005040 Showing 1 location **Job Details** **Description** If you thrive in a team atmosphere, have a passion for interacting with people and problem solving issues then we want to meet you! Vector Security Networks is hiring a Sr. Specialized...
-
Senior Engineering Manager
4 days ago
Gainesville, Florida, United States City of Gainesville Full timeJob SummaryWe are seeking a highly skilled and experienced Senior Engineering Manager to join our team at the City of Gainesville. As a key member of our engineering department, you will be responsible for coordinating and supervising teams of engineers and technicians in planning, developing, and implementing large-scale engineering projects.Key...
-
Test Design Engineer
3 months ago
Gainesville, United States Exactech Full timeTest Design EngineerDepartment: Engineering, Core Employment Type: Full Time Location: Gainesville, FL Reporting To: Director E&D Description To provide design, engineering, testing and analysis support to other engineers and designers in the development and maintenance of orthopedic implants and instruments. Key Responsibilities Provide design,...
-
Software Developer
3 weeks ago
Gainesville, United States Prevent Overdose Inc. Full timeFall Intern Cohort 2024Our Organization: Prevent Overdose Inc.About Us: Prevent Overdose Inc. is a national nonprofit organization dedicated to equitably distributing harm reduction supplies to high-risk individuals likely to witness or experience an overdose. Over the past year, we have distributed $90,000 worth of Narcan, an opioid overdose reversal drug,...