Medical Device Design Quality Engineer

EnovisUSA, TX

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Overview

Schedule

Full-time

Education

Engineering (PE)

Career level

Senior-level

Remote

On-site

Job Description

Who We Are

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.

What You'll Do

At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it.

Because that's how we change the lives of patients for the better. And that's how we create better together.

As a key member of the Quality Assurance team you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Job Title:

Quality Assurance Engineer - Design Quality Focus

Reports To:

Design Quality Engineering Manager

Location:

Austin, TX

Business Unit Description:

US Surgical

Job Title/High Level Position Summary:

Utilizing a comprehensive knowledge of engineering and problem-solving principles, this position is responsible for a variety of complex activities regarding the design, implementation, and maintenance of quality assurance procedures and work instructions to ensure external safety, quality, and compliance with complex Company standards and government regulations.
This position primarily supports New Product Development and Sustaining Product Development and serves as the QA representative on various PD initiatives.

Key Responsibilities:

Participating in design and manufacturing reviews
Generating DFMEAs/UFMEAs and participating in risk analysis discussions
Reviewing and approving design and development documentation
Serve as subject matter expert for design quality in ISO and FDA audits
Authoring procedures and work instructions that define and govern the quality system
Conduct internal audits of the quality system and other business functions
Evaluating nonconforming material and dispositioning based on cross-functional engineering review
Assuring compliance to internal and external specifications and standards (i.e. GMP, ISO, FDA, MDD)
Reviewing trends in device failures associated with customer complaints and nonconforming material
Leading and owning corrective and preventive actions
Participating in Health Hazard Evaluations
Working on complex special projects as assigned

Minimum Basic Qualifications:

Bachelor's in Biomedical or Mechanical Engineering and 3+ years of experience, with at least 1 year in design focused environment (or equivalent combination of education and years of experience).
Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required; preferred knowledge of ISO13485 quality standards.
Knowledge of technical writing quality and best practices.
Required basic knowledge of manufacturing processes: key focus into metrology, precision machining, grinding, product cleaning, and sterilization.
Individual should have knowledge of Microsoft Office Suite of software or equivalent.

Travel Requirements:

Up to 10%

Desired Characteristics:

Preferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM.
Prefer CQE, Lean, or 6 Sigma Certification.
Advanced knowledge of ISO 14971 and risk management principles
Detail oriented and analytical

Physical Requirements:

Ability to sit/stand for long periods of time
Ability to lift/carry/pull up to 25 lbs

EQUAL EMPLOYMENT OPPORTUNITY

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

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FAQs About Medical Device Design Quality Engineer Jobs at Enovis

What is the work location for this position at Enovis?

This job at Enovis is located in USA, TX, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Enovis?

Employer has not shared pay details for this role.

What employment applies to this position at Enovis?

Enovis lists this role as a Full-time position.

What experience level is required for this role at Enovis?

Enovis is looking for a candidate with "Senior-level" experience level.

What education level is required for this job?

The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.

What is the process to apply for this position at Enovis?

You can apply for this role at Enovis either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.