PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success: People, Technology and Service.
Coordinates and executes engineering activities (both internally and of external engineering resources) to design, manufacture, test and validate PTS equipment to meet regulatory requirements and product specifications. This position is also responsible for adherence to design controls as outlined by ISO and Federal Regulations in the development of new products and processes as well as improvements to existing products and processes.
Identify and implement improvements to production equipment and techniques.
Lead Operations validation activities in accordance with regulation guidelines.
Work with external suppliers to resolve product issues.
Confer with Management Team, Operations, and Sales/Marketing to determine feasibility, cost effectiveness for new products, or potential changes to existing products or packaging.
Lead selection of manufacturing technologies for new and/or improved productions.
Manage Equipment Calibration Program to ensure compliance in task completion and documentation.
Oversee equipment scheduled maintenance to ensure compliance in task completion and documentation.
Implement operational metrics for shop floor SPC program.
Lead Operations scrap reduction and rate improvement efforts.
Ideal Candidate Should Have:
Bachelor’s Degree (BS ME preferred) from an accredited college or university
Minimum Five (5) years’ experience in the engineering discipline with FDA regulated validation history
Must have experience with design software (SolidWorks preferred), plastics molding, and/or medical device manufacturing
Experience in the medical device industry is preferred
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Employee works in a typical office environment. The employee occasionally works near production equipment.
PTS is an Equal Opportunity Employer.