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 authority.
Comfortable engaging with technical experts, manufacturing personnel, quality and regulatory professionals, suppliers, clinicians, and senior leadership.
Intellectual curiosity and the ability to quickly become proficient in unfamiliar technical domains.
Electro-mechanical product development experience is highly desirable, including the integration of mechanical components with motors, sensors, actuators, electronics, controls, or other electromechanical systems, with demonstrated ability to collaborate effectively across mechanical, electrical, software, and manufacturing engineering disciplines.
Medical device regulatory experience, a plus.
Dental adhesives/materials experience, a plus.

Other SUCCESS FACTORS:

Leads with a Continuous Improvement Mindset: Looks for opportunities to continuously improve processes and workflow, utilizing Envista Business Systems (EBS); is good at figuring out what to measure to track progress; sets up visual management systems to track progress and facilitate problem solving; is a master at the effectiveness and efficiency of work systems; can quickly diagnose and fix a workflow problem.
Results Oriented: Address problems with drive and energy with an eye on results, costs and the bottom line; focuses on actions and outcomes; drives to finish everything s/he starts
Manages Diverse Relationships: Relates well to a wide variety of diverse styles and is open to differences; effective up, down, sideways, inside, and outside; builds diverse networks; quick to find common ground; Interpersonally agile; easy to approach and talk to; relates well to all kinds of people.

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Operating Company:

Ormco

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

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