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.
Leads the planning and designing of medical device instrumentation systems architecture, authoring product requirements and specifications, error budgets and risk management documentation. Ensures the accuracy and effectiveness of the system meets business/Customers' requirements. Monitors the performance of systems and subsystems, suggests improvements and (re-)allocations of error budgets to achieve overall performance. Verifies and reviews system related documents/reports including sub-system, software, hardware requirements, engaging to ensure consistency, alignment and compliance. Works on advanced, complex technical projects or business issues requiring state of the art technical and Point-of-Care (PoC) industry knowledge. Works autonomously. Goals are generally communicated in solution or project goal terms. Provides an advisory leadership role for the work group through knowledge in systems engineering, risk management and error budget statistics. Supports the generation of technology roadmaps.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Defines, coordinates and aligns the elements that define a system and its performance, i.e., product requirements, product architecture and system error budget.
· Capture, document and baseline Customer and design requirements for PDP projects, using an appropriate tool that enables unique, numerical identifiers for each requirement for tracking, management and change control.
· Performs and coordinates risk analysis for PDP projects, providing appropriate documentation and cross-reference for demonstrating compliance.
· Create system error budgets, allocating error targets to various portions of the system in their respective requirements and specifications. Tracking progress, analyzing data and reporting on achievement of system performance.
· Works with R&D and Product Support to perform risk management assessments, updates to periodic product reviews and the management of current product lines.
· Creates, maintains and updates product and technology road mapping to assist in the long-term planning of projects, research and feasibility studies.
· Subject matter expert on requirements documentation system, change control / management of requirements through the PDP process, coordinator of change control board.
· Works closely with others’ design verification and validation activities to ensure traceability in accordance with regulatory guidelines.
· Confers with management team, Production, Sales, and Marketing to determine completeness in PDP new product requirements and consistency with future departmental directions.
· Participates in arbitration of selecting design concepts and technologies used for new and/or improved products.
· Other duties as directed by the reporting supervisor.
EDUCATION and/or EXPERIENCE
· Bachelor’s degree (B.S.) in Engineering or related field from an accredited college or university, advanced degree desired
· Ten (10) years of experience in the systems engineering discipline
· Medical diagnostic instrumentation experience is a plus
· Experience in the medical device or related regulated industry is strongly preferred
· Demonstrated competence with requirements management tools, statistical analysis and tools, M/S Office Suite of programs, and cross-functional, interpersonal communications skills will be key to successful performance in this position.
The work environment characteristics described 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 and lab equipment.
PTS is an Equal Opportunity Employer.Company Description
PTS Diagnostics is a medical device manufacturer of highly accurate point-of-care diagnostic devices and test strips that measure a patient's glucose, cholesterol and cotinine (tobacco/nicotice) results, as well as provide ongoing chronic disease management by monitoring A1C results. The company's products are distributed and sold worldwide. PTS has been named to the Inc. 5000 Fastest Growing Private Companies list in 2013, 2014, 2015 and 2016.