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Program Manager - Manufacturing Engineering We are a global medical device company and a leader in new product development and medical education in orthopedics. Working as a Program Manager, you will generate, prioritize and manage various engineering projects. The project management team is responsible for development and execution of cross-functional projects to support Manufacturing goals which may focus on cost reductions, insourcing, new product launches, cycle time improvements, scrap....


Process Engineering Supervisor This supervisor will provide engineering supervision, leadership, and project management to manufacturing, assembly, and packaging process improvement projects and support of new product introductions. Also, they supervise a team of direct salaried and hourly reports including Process/Manufacturing Engineers, Engineering Technicians, and validation resources. Essential Duties and Responsibilities:Develop and support systems for proper design, control, and....


Engineer II - Manufacturing - Laser Welding/Laser Marking Main Objective: Design, develop, implement and improve manufacturing processes to produce cost effective quality medical device products and systems. Provide manufacturing engineering expertise to create, document and implement required procedures and documents. The successful candidate for this position will have considerable experience with laser welding & marking. Experience with medical device product cleaning (solvent....


Sr. Manufacturing Engineer Main Objective: Design, develop, implement and improve manufacturing processes to produce cost effective quality medical device products and systems. Provide manufacturing engineering expertise to create, document and implement required procedures and documents. This position will be located primarily at the SC Manufacturing Facility, however, the successful candidate must be able to work at the manufacturing Fl location if needed. Essential Duties and....


Sr Regulatory Affairs Specialist-EU Main Objective: Generates and manages submission documents for new products or changes to existing regulatory filings. Maintains understanding and compliance requirements of regulatory affairs affecting company operations and products. Acts as a liaison between the company and the Notified Bodies and facilitates submissions to the Notified Bodies. Essential Duties and Responsibilities:Acts as the primary liaison between the company and the Notified....


Manufacturing Engineer Main Objective: Responsible for supporting Engineering Manager for the life cycle development of Class I, II and III medical devices, including new product development and maintenance of released products. This includes design, develop, implement and improve manufacturing processes to produce cost effective quality medical device products and systems. Provide manufacturing engineering expertise to create, document and implement required procedures and documents.....


Sr Quality Engineer Main Objective: Responsible for various Quality Assurance functions for manufacturing development of medical devices in the achievement of company goals. Design, develop, implement, and improve manufacturing processes to quality medical device products and systems. This position requires leadership skills, the willingness, and ability to mentor Quality Assurance team members and contributions beyond objectives and expected performance. Essential Duties and....


Sr QA Validation Engineer -Manufacturing Summary Requirements: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Main Objective: Responsible for supporting the Validation Manager with all process validation related support for....


Quality Engineering Manager Main Objective: Responsible for ensuring that the Manufacturing Quality System is effectively established, deployed, maintained, and continually improved. Works closely with Operations Management to drive and maintain world-class manufacturing operations and quality outcomes. Manages, directs, and mentors the efforts of QA Engineering and QA Technicians. Monitors and reports on the performance of the quality system to management and establishes the format and....


Regulatory Affairs Specialist Essential Duties and Responsibilities:With minimal supervision, prepares and writes 510(k) submissions and Letters-To-FileAct as the regulatory representative on product development teams for new and modified devicesDevelops the regulatory strategy for new and modified devices for the U.S.Reviews device changes to assess regulatory impactGathers information and data from other departments and external resources for regulatory submissions in both U.S. and....


Sr Systems Engineer MAIN OBJECTIVE: Responsible for full life cycle development of Class I and II medical devices, which includes initiation, design, development, execution, verification/validation, release, and product maintenance. Recognized as a technical leader and resource. ESSENTIAL DUTIES AND RESPONSIBILITIES: Lead team efforts in establishing program design inputs and/or requirements, ensuring compliance to Company QMS and global standards and regulatory requirementsLead teams in the....


Sr. Product Development Engineer - Knee Arthroplasty Main Objective: Responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance. Essential Duties and Responsibilities:Designs components or functional systems, and modifies existing designs to develop or improve products and facilitate manufacturing operations.Recommends alterations to development and design to improve quality of products and/or....


Senior Packaging Engineer Main Objective: Provides packaging engineering and related support to Design Engineering and when required, contract packaging suppliers. Determine and administer changes to improve overall package performance and/or cost reduction. Support and assist the companies packaging objectives. Essential Duties and Responsibilities:Using a CAD program, assist in the design and development of packaging components for medical devices as required per quality standards.Create and


Manufacturing Engineering Manager Main Objective: Lead team to rapidly develop, implement and improve capable and cost effective manufacturing processes that produce quality products. Essential Duties and Responsibilities:Develop and utilize systematic and comprehensive methods and tools to accomplish objectivesVoice of the CustomerRequirements FlowUse ConditionsEngineering Concept Generation and SelectionProcess Development Robust EngineeringDesign for Manufacturability, Assembly, Inspection,


Sr. Supplier Quality Assurance Engineer Main Objective: To manage and maintain supplier base to assure products and processes internally and externally meet specifications, improve supplier product quality performance, and determine adequate receiving inspection plan. Essential Duties and Responsibilities:Responsible for reviewing design drawings and processes with suppliers to assure inspectability and compliance.Work with suppliers to improve product and process quality through onsite....


Quality Engineering Manager Main Objective: To oversee, manage and provide direction to the Quality department that will effectively and profitably meet or exceed the internal and /or external client’s expectations by providing superior quality products and service. Essential Duties and Responsibilities:Manages and directs the efforts of the Quality Control Inspectors and Quality Control Supervisors.Supervises Quality Engineers and Quality Assurance Technicians assigned to manufacturing....


Manager - Quality Engineering Main Objective: Responsible for leading quality engineering team for design, development transfer, QA manufacturing and post-market surveillance of FDA Class I and II, EU Class I, IIa, IIb and III medical devices in the achievement of company goals. Essential Duties and Responsibilities: Manages Quality Supervisors, Quality Engineers and Quality Assurance Technicians assigned to design and operation support activities to provide timely and efficient flow of....


Program Manager Main Objective: The Program Manager is primarily responsible for translating the design needs of the Product Management and Design Groups into a product. From the delivery of initial prototypes to managing the handoff from design to manufacture of formal new products and all Operational activities related to it. This includes adhering to policies and procedures necessary to ensure efficient and effective execution of these projects. ESSENTIAL DUTIES AND RESPONSIBILITIES:Manages


Product Improvement Engineer MAIN OBJECTIVE: Manage and coordinate as assigned Sustaining Engineering tasks including design, engineering, documentation, manufacturability and qualification of the project as required. ESSENTIAL DUTIES AND RESPONSIBILITIES: Designs components or functional systems, and modifies existing designs to develop or improve products and facilitate manufacturing operations.Manage and coordinate as assigned Rapid Response Projects including the design, engineering,....


Project Manager, Process Engineering Main Objective: The Project Manager’s will own scope, schedule, and cost of various high impact projects. They serve as a fast response resource to resolve or mitigate problems and constraints and provide project management, technical guidance, and strategic direction to cross functional stakeholders in expediting execution of process improvement and validation activities. Essential Duties and Responsibilities:Identify opportunities for changing, improving....

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