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

envista; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Envista in Pomona, CA is seeking a Senior R&D Mechanical Engineer II to translate unmet customer needs into commercially viable medical devices. This role combines innovation with hands-on engineering and requires onsite presence four days per week, working with cross-functional teams across R&D, Manufacturing, Quality, Regulatory, Marketing, and Supply Chain.

You will lead design and development of next generation orthodontic products, serve as SME for fixed appliances or aligners, drive

Qualifications

• Bachelor's degree in Mechanical Engineering from a credited university.
• 7+ years of progressive mechanical engineering and product development experience, preferably within medical devices.
• Hands-on mechanical design experience including concept generation, mechanism design, tolerances, DFM/DFA.
• Generate novel product concepts and translate ideas into prototypes and development programs.
• Scientific literature evaluation, GLP understanding, and strong communication.

Responsibilities

• Develop next generation orthodontic products from concepts to prototypes.
• Lead or support multiple product development projects beyond SME.
• Participate in design reviews and verify/validate designs.
• Develop test protocols, reports and risk assessments.
• Collaborate with cross-functional engineers and manufacturing for transitions to production.
• Advise manufacturing, QA and procurement on materials and processes.
• Ensure IQ, OQ, and PQ compliant equipment before production release.
• Travel up to 10%.

Skills

CAD

Statistical methods

Communication

Prototyping

Design reviews

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

MS Office Suite

Job description

JOB SUMMARY

The Senior R&D Mechanical Engineer II is a highly creative and technically strong mechanical design engineer with a demonstrated ability to translate unmet customer needs and early-stage concepts into commercially viable medical devices. This individual combines innovation, hands-on engineering, and strong business awareness with exceptional communication and collaboration skills. They are self-motivated, intellectually curious, comfortable operating in ambiguity, and capable of independently driving projects from concept generation through commercialization while influencing cross-functional teams across R&D, Manufacturing, Quality, Regulatory, Marketing, and Supply Chain. The selected candidate must reside within a commutable distance to Pomona, CA. This is not a hybrid or remote opportunity and requires onsite presence 4 days per week.

PRIMARY DUTIES & RESPONSIBILITIES

• Responsible for development of next generation/breakthrough orthodontic products. This includes translation of emerging technologies to prototypes and ultimate products.
• Subject Matter Expert (SME) in either orthodontic fixed appliances or aligners.
• Lead or support multiple product development projects as needed beyond SME.
• Participate in design reviews and collaborate with engineers to verify and validate designs.
• Work and collaborate with cross-departmental engineers to develop test protocols, reports, and risk assessments.
• Work with the R&D, Procurement and Manufacturing teams to identify, evaluate and qualify suppliers and raw materials as required for new product development (NPD) and establish instructions, processes and plans to transition projects from R&D to Manufacturing.
• Serving as the technical advisor to manufacturing, QA and procurement staff for raw material requirements, vendors, developing material test protocols and fabrication processes.
• Ensure test equipment meets all safety, quality, and efficiency standards through IQ, OQ, and PQ before released to production.
• Research, suggest, and/or implement new materials that can improve product's performance.
• Leverage automation tools to streamline manufacturing processes.
• Prepare advanced technical reports and white papers. Summarizes and communicates data of a complex nature to non-technical audiences.
• Able to lead to small intermediate projects with minimal supervision; is accountable for results and owns the data.
• Design and carry out experiments with scientific methods. Hypothesis to Conclusions reporting.
• Analyze and understand market and technology trends.
• May support all phases of product development including manufacturing scale, design control, packaging, documentation, risk assessments, product performance verification, end user validation and commercialization.
• Will interface with various customer personnel and internal Product Management to determine both articulated and unarticulated needs to develop products that meet/exceed customer needs while maximizing value in use.
• Conduct feasibility studies and provide constructive feedback on prospective projects/technologies.
• Plan schedule of research according to project schedule and establish daily or weekly routines accordingly
• Develop in-depth knowledge of new and existing products.
• Train and supervise other research staff.
• Evaluation of ideas, patents and emerging technologies.
• Up to 10% travel may be required.

Job Requirements

• Bachelor's degree in Mechanical Engineering from a credited university.
• 7+ years of progressive mechanical engineering and product development experience, preferably within the medical device or other 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).
• Generate novel product concepts and rapidly translate ideas from sketches, observations, conversations, or unmet customer needs into prototypes and product development programs.
• Scientific literature evaluation and reporting experience.
• Understanding good laboratory practices (GLP).
• Proficient in CAD, MS Office Suite, statistical methods.
• Professional verbal and written communication skills.

PREFERRED QUALIFICATIONS

• Demonstrated history of leading new product development efforts from concept through commercialization, preferably within the medical device industry.
• Demonstrate out-of-the-box thinking.
• Advanced 3D design work; preferably in SolidWorks
• Handle initial patent disclosure and IP of new technologies. Conveying all known patent and IP research to internal counsel and support prosecution.
• Ability to communicate effectively across the enterprise, as well as various groups such as Regulatory, QA/QC, Supply Chain, Marketing, Customer Service, Sales) and external customers and suppliers.
• Exceptional interpersonal and collaboration skills with the ability to influence cross-functional teams without direct a