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The Design Assurance Engineer II manages design control, risk management, and regulatory compliance for dental consumables throughout the product lifecycle. They collaborate cross-functionally to support verification, validation, CAPA activities, and continuous improvement initiatives.
Candidates must hold a bachelor's degree in an engineering field with at least 2 years of experience, or a high school diploma with 6 years of relevant experience. Proficiency in design controls, risk management tools like FMEA, and cross-functional collaboration is required.
Job Description:
Position Summary: The Design Assurance Engineer II supports the development, manufacturing, and lifecycle management of dental consumables by ensuring design control, risk management, quality, and regulatory requirements are effectively incorporated throughout the product development and manufacturing processes. This role owns assigned Design Assurance deliverables, including design changes, requirements traceability, and verification and validation support. Working cross-functionally with R&D, Manufacturing, Regulatory Affairs, Quality, and Operations, this role contributes to product risk management, test method development, data analysis, reliability evaluations, investigations, CAPA activities, and process validation.
Essential Duties and Responsibilities:
With minimal supervision, owns defined design assurance deliverables (e.g., design changes, traceability, V&V support).
Supports development and review of design inputs, outputs, and verification/validation plans.
Contributes to and maintain product risk management files (FMEA, hazard analysis).
Supports test method development, data analysis, and reliability evaluations.
Participates in investigations, CAPA activities, and process validation support.
Ensures readiness for design reviews and phase/toll-gate activities.
Actively participates in continuous improvement activities including but not limited to Kaizen and 5S events, Problem Solving Process, Value Stream Mapping, and Transaction Process Improvement.
Effectively collaborates with cross-functional teams to meet business objectives.
Adheres to all company policies and procedures including safety and quality.
Travels up to 5% domestically.
Incidental Duties: The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Job Requirements:
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. This individual must be able to function in a fast-paced environment, where priorities may change rapidly. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience:
Bachelor’s degree in engineering (Mechanical, Electrical, Biomedical, or related technical field) plus minimum of 2 years of relevant work experience required OR
High school or equivalent plus 6 years of relevant work experience required.
Skills and Abilities:
Working knowledge of design controls and risk management, including FMEAs and traceability.
Understanding of verification/validation methods, testing strategies, and design change processes.
Familiarity with root cause analysis tools and basic statistical methods.
Ability to support cross-functional teams (R&D, Manufacturing, RA, Operations) and drive assigned workstreams.
Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Constantly sits.
Frequently uses hands and fingers.
Occasionally walks and stands.
Rarely bends and stoops.
Occasionally reaches up/down with arms.
Occasionally lifts and/or move.
#LI-MM1
IND123
Target Market Salary Range:
Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.
$95,600 - $116,900Operating Company:
KerrEnvista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.
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.
Partnering with dental professionals to improve lives.
Envista is a global leader in the dental industry, uniting more than 30 trusted brands—including DEXIS, Kerr, Nobel Biocare, and Ormco—under one mission: partnering with dental professionals to improve lives. With a heritage of category-defining innovation, our brands have shaped modern dentistry: Nobel Biocare introduced the first dental implant, Ormco pioneered wire-and-bracket orthodontics, Kerr has supported clinicians for over 135 years, and DEXIS helped advance CBCT imaging. Guided by a culture of customer centricity and continuous improvement through the Envista Business System, we deliver a comprehensive portfolio of technologies, consumables, and services that empower clinicians to provide confident, efficient care—today and for the future. Learn more at www.envistaco.com.
Offices: 200 S Kraemer Blvd, Brea, California 92821, US · Prague, CZ · San Jose, CR · Suzhou, CN
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