enVista

Design Assurance Engineer II

enVista$95K — $116K *
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in engineering (Mechanical, Electrical, Biomedical, or related technical field) and a minimum of 2 years of relevant experience, or high school diploma and 6 years of relevant experience required.
  • 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 work effectively within cross-functional teams.

Responsibilities

  • Own defined design assurance deliverables with minimal supervision.
  • Support development and review of design inputs, outputs, and verification/validation plans.
  • Maintain product risk management files, including FMEA and hazard analysis.
  • Assist in developing test methods, conducting data analysis, and performing reliability evaluations.
  • Engage in investigations, CAPA activities, and process validation support.
  • Prepare for design reviews and phase/toll-gate activities.
  • Participate in continuous improvement activities, such as Kaizen and Value Stream Mapping.

Benefits

  • Medical, dental, and vision benefits.
  • 401K match.
  • Participation in annual performance bonus program.
Full Job Description
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.


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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 - $116,900

Operating Company:
Kerr

About enVista

enVista is a global software solutions and consulting services firm headquartered in Carmel, Indiana. The company provides consulting, implementation, and managed services in supply chain, transportation, retail, and IT. enVista's services include supply chain strategy, transportation management, warehouse management, labor management, and IT services. The company has offices in North America, Europe, and Asia.
Learn more about enVista
Size
11,200 employees
Market Cap
$5.3 billion
Industry
Net Income
$33.3 million
Founded
2002
5 Year Trend
-2.1%
Revenue
$2.2 billion
NASDAQ

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