Job Description & Skill Requirement:
Must Have:
Medical device design, development & manufacturing, experience of products with electrical functionality an advantage
Examples of critical thinking and proven project execution
Leading a cross functional teams and leveraging solid PM skills e.g. project planning, communication, risk management, etc. Work collaboratively and with respect & humility with a cross functional team to drive project execution for medical devices, prioritizing safety, quality service, on-time execution.
Lead team to define goals, provide solutions and align on path forward, drive/track/communicate progress, adapt as needed with team.
Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures.
Use scientific problem solving methodologies e.g. DMAIC, process map.
whys, Is/Is not, etc. Drive solid decision making.
Attention to detail, accuracy, to ensure own work meets required standard (compliant to quality management system, grounded in scientific facts and/or data, within safety/scope/schedule/cost guidance).
Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges
Experience with medical devices sterilization methods (i.e., ethylene oxide, radiation, etc.) Experience implementing appropriate risk mitigation actions with knowledge of packaging or process and process Risk Management as per FDA & ISO standards.
Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools. Working knowledge of SolidWorks or other packaging CAD programs (i.e., TOPS, SolidWorks, CREO, etc.).
Experience with Minitab or other statistical software.

Nice to Have:
Change control of Medical Devices
Equipment Commissioning / Qualification
Process Validation
Computer System Validation (CSV)
Manufacturing, Packaging and Laboratory Equipment
Technical experience (Trouble shooting) or any similar experience or background
Quality / Process Control / Assurance of Medical Devices

Pi-square technologies is a Michigan (USA) Headquartered Automotive Embedded Engineering Services company, Synergy Partner for major OEMs and Tier 1s and their implementation partners in Automotive Embedded Product Development, Projects, Requirements Analysis, Software Design, Software Implementation, Efficient Build, Release Process, and turnkey software V & V Services. We have more than 20+ years of industry expertise with specialization in the latest cutting-edge automotive technologies such as Infotainment, connected vehicles, Cyber security, OTA, and Advanced Safety/ Body electronics.