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

Envista Holdings Corporation•Pomona, CA

4d•$121,300 - $148,300•Onsite

About The Position

The Senior R&D Mechanical Engineer II develops next-generation and breakthrough orthodontic products by translating unmet customer needs, emerging technologies, and early-stage concepts into prototypes and commercially viable medical devices. The role calls for strong hands-on mechanical design, business awareness, creativity, communication, and collaboration. The engineer independently drives projects from concept generation through commercialization and influences teams across R&D, Manufacturing, Quality, Regulatory, Marketing, and Supply Chain. The person hired must live within commuting distance of Pomona, California. This is an onsite opportunity requiring presence four days per week; it is not hybrid or remote. Up to 10% travel may be required. The engineer serves as a subject matter expert in orthodontic fixed appliances or aligners and may lead or support other product-development projects. Work may span feasibility, prototyping, design control, packaging, documentation, risk assessment, verification, end-user validation, manufacturing scale-up, and commercialization. The role also involves supplier and material qualification, manufacturing process development and transition, test-equipment qualification, experimentation, technical reporting, and collaboration with customers and internal Product Management to identify articulated and unarticulated needs. The position may include training and supervising research staff, evaluating ideas, patents, and emerging technologies, and advising Manufacturing, Quality Assurance, and Procurement on raw materials, vendors, testing protocols, and fabrication processes. The engineer plans research around project schedules and develops in-depth knowledge of new and existing products.

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 translate sketches, observations, conversations, and 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, Microsoft Office Suite, and statistical methods.
Professional verbal and written communication skills.

Nice To Haves

History of leading new-product-development efforts from concept through commercialization, preferably in the medical-device industry.
Out-of-the-box thinking.
Advanced 3D design experience, preferably with SolidWorks.
Ability to handle initial patent disclosures and intellectual property for new technologies, convey known patent and IP research to internal counsel, and support 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 the 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, translating emerging technologies into prototypes and commercial products.
Serve as a subject matter expert in orthodontic fixed appliances or aligners, and lead or support multiple product-development projects.
Participate in design reviews and collaborate with engineers to verify and validate designs.
Collaborate across departments 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; establish instructions, processes, and plans for transitioning projects to Manufacturing.
Advise Manufacturing, Quality Assurance, 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 production release.
Research, recommend, and implement materials that can improve product performance.
Use automation tools to streamline manufacturing processes.
Prepare technical reports and white papers, and communicate complex data to non-technical audiences.
Lead small to intermediate projects with minimal supervision; own project data and be accountable for results.
Design and conduct scientific experiments, reporting from hypothesis through conclusions.
Analyze market and technology trends.
Support product-development phases that may include manufacturing scale-up, design control, packaging, documentation, risk assessments, product-performance verification, end-user validation, and commercialization.
Work with customer personnel and internal Product Management to identify articulated and unarticulated needs and develop products that meet or exceed customer needs while maximizing value in use.
Conduct feasibility studies and provide constructive feedback on prospective projects and technologies.
Plan research schedules according to project schedules and establish daily or weekly routines.
Develop in-depth knowledge of new and existing products.
Train and supervise other research staff.
Evaluate ideas, patents, and emerging technologies.
Travel up to 10% as required.