Medical Device Design Quality Engineer

Enovis; Austin (TX); On-site; USD 95,000 - 120,000; Full time

Job summary

Enovis, a medical technology company in Austin, TX, seeks a Quality Assurance Engineer - Design Quality Focus to ensure external safety, quality and compliance with GMP and FDA standards. You will support New Product Development and Sustaining PD initiatives as QA representative.

Responsibilities include design reviews, DFMEAs/UFMEAs, audits, ISO/FDA readiness, and developing quality procedures, with up to 10% travel.

Qualifications

• Bachelor's in Biomedical or Mechanical Engineering and 3+ years of experience, with at least 1 year in design focused environment.
• Background in Medical Device or other highly regulated industry; ISO13485 knowledge preferred.
• Technical writing quality and best practices; familiarity with GMP, ISO, FDA, MDD.

Responsibilities

• Participating in design and manufacturing reviews.
• Generating DFMEAs/UFMEAs and risk analysis discussions.
• Reviewing and approving design and development documentation.
• Serve as SME for design quality in ISO and FDA audits.
• Authoring procedures and work instructions that govern the quality system.
• Conduct internal audits of the quality system and other functions.
• Lead corrective and preventive actions.

Skills

Quality Assurance

Design Quality

Risk Management

Technical writing

Audits (ISO/FDA)

Education

Bachelor's in Biomedical or Mechanical Engineering

Tools

SolidWorks

SolidWorks ePDM

Oracle R12

Agile PLM

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.

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.