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Ormco, headquartered in Brea, CA, is a global leader and innovator of orthodontic products and solutions to enhance the lives of our customers and their patients. For nearly 60 years, Ormco has partnered with the orthodontic community to help create over 20 million smiles in over 130 countries. Distinguished products range from twin brackets (Symetri™ Clear, Titanium Orthos™ and Mini Diamond™) to pioneering the self-ligating appliances with the Damon™ System (including Damon™ Q2 and Damon™ Clear 2). Ormco’s Insignia™ Advanced Smile Design™ provides an all-inclusive customized indirect bonding solution for increased clinical efficiency. Spark™ Clear Aligner System is designed to meet the needs of the orthodontist with the TruGEN™ material and 3D Approver software. From personalized service to professional education programs and marketing support, Ormco is committed to helping orthodontists achieve their clinical and practice management objectives.Operating Company:SparkJob Description:The primary role is to lead moderate to high complexity projects ( 10 core team members, project cost $0.5M to $5M, multi-site) in support of critical business objectives.The role will support both New Product Development and Major Sustaining projects.The Program Manager is responsible for leading the cross functional team in planning, daily management and execution, on time delivery, implementation, and commercialization.PRIMARY DUTIES AND RESPONSIBILITIES: Establish clear project objectives and deliverables. Facilitate the building of complex project plans Utilize master schedule and daily management to drive tasks to completion. Use key project metrics to maintain the health of the project. Establish project budget estimation and manage project to budget. Use the issue tracker to implement effective countermeasures and drive countermeasures to closure with a sense of urgency. Establish a risk register to anticipate highest project risks and drives team to head off risks and manage contingency plans. Mentor team members and proactively work with functional managers to address issues. Lead a cross functional, multi-site, matrixed team to delivery on commitments. Regularly communicate with core team members, functional managers, and leadership team to ensure alignment. Effectively communicate difficult information to the leadership team. Manage the project through our tollgate process DHF creation and support of audits of our Design Control process and documentation. Experienced with preparation and filing of regulatory submissions, 510k, Technical Files Develop an understanding of Envista Business System (EBS) processes and tools and utilize in the execution of projects (i.e. Problem Solving Process (PSP) and Visual Project Management (VPM)).Job Requirements: Experienced in the development of medical devices. Has knowledge of all aspects of product development and brings expertise to help team members identify critical interdependencies and gaps. Strong interpersonal skills that create followership and motivate team members. Driven and motivated individual with demonstrated critical thinking and analytical skills. Unquestionably high ethical standards and attention to reputational and compliance risks. Organized thinker that can prioritize tasks in real time and exercise judgment in high-paced environment. Excellent oral and written communication skills to support design change documentation, team leadership, project updates, interaction with all levels within the organization and communication with external thought leaders. Sound computers skills demonstrating a firm knowledge of Microsoft Office software (Word, Excel, PowerPoint, Outlook and Microsoft Project). Able to type 40 WPM.REQUIRED: Bachelor’s degree in Engineering or related technical field A minimum of 5 years experience managing projects in medical device and/or other regulated industries using traditional waterfall and/or Agile methods A combination of education/training and 15+ years of the required experience listed above may be considered in lieu of a degree FDA Quality System Regulation Part 820 and ISO 13485 experiencePREFERRED: Preference will be given to candidates who are PMP certified Experience in deploying PMO processes, tools and templates Master’s degreeEnvista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.#LI-SC1Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.Envista is a global family of three companies and more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists’ clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including KaVo Kerr, Nobel Biocare Systems, and Ormco, partner with dental professionals to help them deliver the best possible patient care.Envista separated from Danaher as an independent company in 2019. We brought with us the proven Envista Business System (DBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com .
