Ormco Senior R&D Mechanical Engineer II (Pomona, CA)

Envista Dentistry•Pomona, CA

2d•Onsite

About The Position

Ormco is seeking a highly creative and technically strong mechanical design engineer to translate unmet customer needs and early-stage concepts into commercially viable medical devices. The role combines innovation, hands-on engineering, and business awareness. The engineer will independently drive projects from concept generation through commercialization and influence cross-functional teams across R&D, Manufacturing, Quality, Regulatory, Marketing, and Supply Chain. The selected candidate must live within commuting distance of Pomona, California. This is an onsite role requiring presence four days per week; it is not hybrid or remote. Up to 10% travel may be required. The engineer will develop next-generation and breakthrough orthodontic products, translating emerging technologies into prototypes and products. The position may support all phases of product development, including manufacturing scale-up, design control, packaging, documentation, risk assessments, performance verification, end-user validation, and commercialization. The engineer will also serve as an orthodontic fixed-appliance or aligner subject matter expert, support multiple projects, and provide technical guidance to manufacturing, quality assurance, and procurement teams. The role involves collaborating with customers and internal Product Management to identify articulated and unarticulated needs, conducting feasibility studies, evaluating ideas, patents, and emerging technologies, and communicating complex data to nontechnical audiences. The engineer will design and conduct experiments, prepare technical reports and white papers, develop in-depth product knowledge, and train and supervise other research staff.

Requirements

Bachelor’s degree in Mechanical Engineering from an accredited university.
At least 7 years of progressive mechanical engineering and product development experience, preferably in the medical device or another highly regulated industry.
Extensive hands-on mechanical design experience, including concept generation, mechanism design, material selection, tolerance analysis, design optimization, prototyping, and design for manufacturability and assembly (DFM/DFA).
Ability to generate novel product concepts and rapidly translate sketches, observations, conversations, or unmet customer needs into prototypes and product development programs.
Experience evaluating and reporting on scientific literature.
Understanding of good laboratory practices (GLP).
Proficiency in CAD, the MS Office Suite, and statistical methods.
Professional verbal and written communication skills.
Ability to work independently, operate in ambiguity, and collaborate across functions.

Nice To Haves

Demonstrated history of leading new product development from concept through commercialization, preferably in the medical device industry.
Out-of-the-box thinking.
Advanced 3D design experience, preferably in SolidWorks.
Experience handling initial patent disclosures and intellectual property for new technologies, conveying patent and IP research to internal counsel, and supporting prosecution.
Ability to communicate effectively across the enterprise and with Regulatory, QA/QC, Supply Chain, Marketing, Customer Service, Sales, external customers, and suppliers.
Exceptional interpersonal and collaboration skills, including the ability to influence cross-functional teams without direct authority.
Comfort engaging with technical experts, manufacturing personnel, quality and regulatory professionals, suppliers, clinicians, and senior leadership.
Intellectual curiosity and ability to become proficient quickly in unfamiliar technical domains.
Electro-mechanical product development experience, including integrating mechanical components with motors, sensors, actuators, electronics, controls, or other electromechanical systems, and collaborating across mechanical, electrical, software, and manufacturing engineering disciplines.
Medical device regulatory experience.
Dental adhesives or materials experience.

Responsibilities

Develop next-generation and breakthrough orthodontic products by translating emerging technologies into prototypes and commercial products.
Serve as a subject matter expert in orthodontic fixed appliances or aligners, while leading or supporting other product development projects as needed.
Participate in design reviews and collaborate with engineers to verify and validate designs.
Collaborate with cross-functional engineering teams to develop test protocols, reports, and risk assessments.
Work with R&D, Procurement, and Manufacturing to identify, evaluate, and qualify suppliers and raw materials for new product development, and establish plans and instructions for transferring projects from R&D to Manufacturing.
Advise Manufacturing, QA, and Procurement staff on raw material requirements, vendors, material test protocols, and fabrication processes.
Ensure test equipment meets safety, quality, and efficiency standards through IQ, OQ, and PQ before its release to production.
Research, recommend, and implement materials that may improve product performance.
Use automation tools to streamline manufacturing processes.
Prepare technical reports and white papers, and summarize and communicate complex data to nontechnical audiences.
Lead small to intermediate projects with minimal supervision, take accountability for results, and own project data.
Design and conduct experiments using scientific methods, reporting from hypothesis through conclusions.
Analyze market and technology trends and evaluate ideas, patents, and emerging technologies.
Support product development phases including manufacturing scale-up, design control, packaging, documentation, risk assessments, product performance verification, end-user validation, and commercialization.
Interface with customer personnel and internal Product Management to identify customer needs and develop products that meet or exceed them while maximizing value in use.
Conduct feasibility studies and provide constructive feedback on prospective projects and technologies.
Plan research schedules around project timelines and establish daily or weekly routines.
Develop in-depth knowledge of new and existing products.
Train and supervise other research staff.
Travel up to 10% as required.