Designs, develops and provides safety testing, repair and maintenance of biomedical equipment. Ensures the equipment is in compliance with applicable regulatory requirements and quality control standards. Requires a bachelor’s degree and 0-2 years of direct experience in the field. Relies on limited experience and judgment. Typically reports to a supervisor.
Corrective and Preventive Action Coach (CAPA) investigates the root cause of a problem with the goal of preventing future problems. Evaluates current issues and plans prevention tactics for future use. Suggest improvements to a company's processes to eradicate undesirable outcomes. Coaches team members. Must obtain CAPA training certification in addition to engineering background or degree.
Designers study, research, develop and design ideas for company's new products and systems. This includes drafting blueprints, creating test prototypes, and overseeing the manufacturing process. They also modify existing products or processes to increase efficiency or improve performance. Bachelor’s degree may be required.
Development engineer designs and develops products for companies. Responsible for testing products as well as conceiving new product concepts. Often works alone but can also work as part of a team. Is overseen by a project manager or other high-ranking executive. Products may or may not be developed based on overall design and test results.
Create and develop effective designs to create packaging that’s functional, cost effective, and fits a project’s needs. This involves generating ideas and concepts, testing designs, working with internal teams during the manufacturing process, and reviewing the efficiency of the final packaging. Must be creative problem-solvers who can overcome a design’s potential obstacles.
Process development engineer develops and creates more efficient processes to increase safety, decrease variability, and increase flow. Evaluates processes in place and provides suggestions. Researches new technologies to make sure processes are in line with corporate goals. Can also provide training to team members. Must obtain degree in the engineering field.
Oversees all aspects of projects to ensure coordination and completion. Establishes project plan with associated milestones and deadlines, assigns responsibilities, and monitors and summarizes progress. Acts as a single point of contact and provides coordination of deliverables. Communicates with internal and external team throughout the project. Prepares status reports for upper management.
Quality assurance engineer oversees development of a product from start to finish. Must evaluate development, testing, and all other phases of product development. Responsible for ensuring products meet company standards and requirements. Can be held accountable for faulty products that have not been tested properly. An engineering degree is required.
Quality engineer evaluates current manufacturing processes to ensure quality standards, prevent problems, and maintaining processing flow. May be required to communicate with both suppliers and vendors. Often required to perform audits and maintain auditing schedule. Must have strong technical writing and communication skills. Typically required to hold a degree in quality assurance or other related field.
Research and development engineers create new products and rethink existing products. Can also be required to research new products and test current products. Often works with marketing teams, executive teams, and other related employees. R&D engineers report to project managers. Must have good leadership and communication skills. An engineering background is preferred.
Regulatory Affairs (RA) Specialist provides support for the maintenance and implementation of RA systems, with focus on Regulatory Information Management System (RIMS) and Regulatory Distribution Controls through SAP Global Trade Services (GTS) software. Requires experience with data analysis and data mining tools to work with RA systems data to suggest improvements for business process. Create and maintain regulatory affairs registrations and licenses in support of regulatory controls for product distribution. Perform and support User Acceptance Testing (UAT) as needed
The Regulatory Affairs Technician responsibilities include assisting in the data input and analysis of data integration into systems. Excellent communication skills and ability to work under deadlines. The ability to organize, follow up with team members around reports and data.
Supplier Quality Engineer is responsible for managing customer specific requirements and technical support for suppliers. This person ensures all suppliers and materials used are in compliance. Must also ensure that quality standards are met for products produced. Job qualifications include a bachelor’s degree, excellent communication skills and advanced knowledge of manufacturing and government compliance.
Sustaining Engineer is responsible for the support of mature products. This includes new feature requests, bug fixes and product enhancements through the lifespan of the product. Educational requirements typically include a bachelor’s degree.
Writes, edits and packages a variety of technical documents, including proposals, articles, brochures, reports and manuals. Relies on knowledge and professional discretion to achieve goals. Usually reports to a supervisor. Significant ingenuity and flexibility is expected. May require a bachelor’s degree and 0-6 years of relevant experience.
Develops, supports and implements basic validation initiatives as defined in site goals and objectives. Responsible for the coordination and documentation of validation efforts with other departments providing validation guidance to all levels for quality assurance, compliance, and continuous quality improvement. Ensures products are developed, manufactured, tested, and delivered according to established procedures that will assure they meet all validation requirements. Develops and executes equipment, material, cleaning, and process validation protocols including statistical analysis of data generated by validation studies. Traditionally requires a bachelor’s degree.