Project Manager

Project ManagerWe're looking for a Project Manager to lead the development of new medical devices from concept through launch. This is a hands-on role at the center of engineering, R&D, quality, and manufacturing, where you'll drive projects through Design Control, manage timelines and resources, and keep teams aligned from early development through final testing. You'll tackle technical and project challenges, manage risk, and make sure products move forward with the quality and rigor required in a regulated environment.Essential Functions:Leads the project team through all phases of Design Control to achieve project goals within established scope, time, and quality constraints.Creates or directs preparation of all documents including, but not limited to protocols, reports, traceability matrices, SDS documents and labeling required for the Design History Files of medical devices.Determines and tracks resources such as time, capital, labor, and equipment required to complete projects.May assist executive management in the preparation of project proposals including scope, schedule, budget, and deliverables.Manages progress of projects to ensure alignment with business strategy, sound application of engineering principles, and adherence to Prismatik's Quality Manual and applicable industry standards.Manages and implements appropriate action with respect to timelines, milestones, planning, and resource allocations.Identifies elements impacting project, such as personnel issues and project gaps, bottlenecks, and risks. Develops solutions and/or implements corrective actions to ease issues, eliminate delays, and mitigate risks using appropriate knowledge, skills, and techniques.Evaluates and analyzes final testing results. Provides manufacturing guidance.Communicates with project stakeholders, various departments, and applicable vendors to achieve design intent.Updates management regarding project strategy, progress, and alignment with executive direction.Creates and produces reports regarding projects for management and team members.Performs other related duties and projects as business needs require at direction of management.Minimum Qualifications:Bachelor's degree in Engineering or scientific related discipline, preferred.Minimum five (5) years of experience in R&D performing higher value-added roles and functions.Minimum three (3) years of experience in project management; medical device industry experience, a plus.Demonstrated knowledge of International Organization for Standardization (ISO) and Food and Drug Administration (FDA) standards and requirements for medical devices.Certification in Project Management, a plus.Pay range: $81,000-115,000/yr Exact compensation may vary based on skills and experience. This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at Glidewell!In addition are the following generous employee benefits: Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more!Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates.