Glidewell

Description

Position at Prismatik

Essential Functions:

• Serves as engineering lead for new product introduction (NPI) projects, from feasibility through full production launch.
• Partners with cross-functional teams, including R&D, Quality, Regulatory, and Operations, to influence design for manufacturability (DFM) and design for assembly (DFA).
• Develops and implements robust manufacturing processes, equipment, fixtures, and documentation to support pilot builds and scale-up.
• Leads and supports process validations in compliance with FDA regulations and ISO 13485 standards, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Generates and maintains design history file (DHF) and device master record (DMR) documentation, including work instructions, process flow charts, and control plans.
• Conducts risk analysis (e.g., Process Failure Mode and Effects Analysis) and identifies control strategies for critical-to-quality (CTQ) characteristics.
• Supports supplier qualification, incoming inspection plans, and component validation.
• Partner with cross-functional teams to define and meet project timelines, milestones, and deliverables.
• Supports training of manufacturing personnel and transfer of knowledge to manufacturing.
• Ensures all activities meet cGMP, FDA 21 CFR Part 820, and other applicable regulatory standards.

Education and Experience:

• Bachelor’s degree in Mechanical, Manufacturing, Biomedical Engineering, or related field.
• Minimum three (3) years of experience in medical device manufacturing, with a focus on Class II devices and/or regulated environments.
• Proven experience in NPI process development, including pilot builds, process validation, and regulatory documentation.
• Strong understanding of FDA QSR, ISO 13485, and risk management (ISO 14971).

Pay Range: $75,000-$100,000/yr

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.