Project Manager - Manufacturing

Prismatik Product Manager

Position at Prismatik

Essential Functions :

• Leads projects through New Product Introduction (NPI) process to support product development lifecycle from ideation to commercialization, including regulatory clearance, design transfer, manufacturing scale-up, and inventory build for launch.
• Leads and manages Class II medical device projects from early concept to launch, including regulatory clearance and inventory build.
• Develops and maintains detailed project plans, schedules, deliverables, risk registers, budget, and resource allocations.
• Monitors project progress to ensure projects are executed on schedule and within approved financial targets. Proactively identifies issues and implements mitigation strategies to minimize risks.
• Partners with project cross-functional stakeholders to align project deliverables and ensure on-time, on-budget execution.
• Prepares and delivers regular project updates, dashboards, and presentations. Serves as the primary communication liaison between project stakeholders and maintains comprehensive project documentation.
• Partners with project stakeholders to prepare and present stage-gate project approval pitches, including detailed timelines, resource planning, and cost of goods sold (COGS) estimates.
• Drives New Product Introduction (NPI) activities, ensuring readiness across design, manufacturing, supply chain, and quality functions.
• Oversees and maintains compliance with design control requirements throughout all project phases, ensuring proper documentation and adherence to FDA and ISO 13485 standards.
• Facilitates design reviews, risk management activities, and stage-gate deliverables within the NPI process.
• Perform other related duties and projects as business needs require at direction of management.

Minimum Qualifications :

Pay range : $95,600-$125,000 / 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. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at recruitment@glidewelldental.com. Please indicate the specifics of the assistance needed.

Note to Current employees : Please apply through Employee Transfer Application to complete the transfer request form.