Sr Validation Engineer at Medtronic in Eatontown, New Jersey

Job Description:

Careers that Change Lives
Responsible for performing and overseeing the validation of manufacturing processes, facility, equipment, system and cleaning processes. Evaluate impact of proposed changes to utilities, equipment and processes on the validated state. Experience with and understanding of regulatory agencies (FDA (Food and Drug Administration), ISO (International Standard Organization), AATB (American Association of Tissue Bank), BSI (British Standard), TGA (Australian Standard), as well as tissue bank/medical device requirements .

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Develop and coordinate execution of protocols for equipment and process validations, prepare final reports following the execution.
• Responsible for evaluation and analysis of data, lead investigation and documentation of all validation deviations and determine impact on the validations.
• Assist in the implementation and maintenance of the Validation Master Plan.
• Design and develop test strategy and methodology for the validation of the products, processes and equipment.
• Train, mentor, and oversee protocol development and validation activities in according with current regulatory requirement and industry standards.
• Participate in product and process development and design transfer activities to ensure launch goals are achieved.
• Participant in equipment development, provide support of User Requirement Specification (URS) creation, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) activities.
• Provide support for pFMEA (Process Failure Mode Effect Analysis), CAPA (Corrective Action and Preventive Action), and QN's (Quality Non-conformance) efforts as assigned. Initiates investigations of problems and deficiencies to ensure a high level of product quality.
• Establish the metrics and monitor the performance of processes, equipment, and tools to verify their efficiency, initiate re-validations and process improvement as needed.
• Act as technical resource, where needed, to help with the design, development, evaluation, or troubleshooting of manufacturing processes, testing procedures and/or other systems.
• Provide technical support to Manufacturing, Strategic Procurement, and Suppliers by interpreting product requirements and resolving technical production problems.
• Work with, but not limited to, Research and Development, Marketing, Quality, Regulatory Affairs, Material Planning, Distribution, Strategic Procurement, Manufacturing facilities and suppliers to provide or secure information, coordinate activities and solve problems.
• Assist in the prevention and resolution of technical production and validation issues with assigned products by working with manufacturing engineering, operations and quality personnel at Medtronic facilities and suppliers.
• Travel as required for company business. Travel could include, but not limited to, visits to Medtronic manufacturing and Distribution facilities, suppliers, and training classes or seminars.

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

• Experience with and effective application of Design, Validation Protocol and Report creation, statistical process control (SPC), design of experiments (DOE), Process Control Plans, Sampling methodologies, Data Analysis.
• Experience with and understanding of Grinding, Assembly, Cleaning, Passivation, Mass Media Operations.
• Knowledge with Six Sigma and Lean Manufacturing.
• Knowledge with Design Verification.
• Excellent communication skills, both verbal and written.
• Effective interaction with personnel at diverse positions within and outside of the organization.
• Value other's ideas and experience working in a team environment.
• Project Management experience or training. Work well under pressure, organized and able to attain results on several projects simultaneously.
• Strong analytical and problem-solving skills and experience applying these skills to resolve technical problems in a manufacturing environment.
• Well-informed and current on manufacturing methods and equipment.
• A thorough understanding of the product development process and its needs.
• Results oriented and self starter.

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)