Medical Device Design Quality Engineer
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Job Location:
Austin, TX - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 Companys extensive range of products services and integrated technologies fuels active lifestyles in orthopedics and more information about Enovis please visit .
What Youll 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 thats how we change the lives of patients for the better. And thats 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:
- Bachelors 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.
Required Experience:
IC
Key Skills
- Mechanical Design
- SOC
- System Design
- GD&T
- CAD
- Creo
- SolidWorks
- Mechanical Engineering
- Perl
- Autocad
- HVAC Design
- Catia
About Company
At Enovis, we develop clinically differentiated medical technology solutions that generate measurably better patient outcomes and transform workflows. Our brands include Aircast, Chattanooga, CMF, Compex, Enovis Surgical, DonJoy, Dr. Comfort, Exos and Procare.
