NPI Quality Engineer

Enovis Corporation; Houston (TX); On-site; USD 87,000 - 104,000; Full time

Benefits offered by this job

Travel up to 20%

Job summary

Enovis Corporation, a medical technology innovator, is seeking a Quality Engineer for the Foot & Ankle Quality NPI team to drive design quality and regulatory compliance across ISO and FDA audits.

The role focuses on DFMEAs/UFMEAs, risk analysis, inspection strategy, and collaboration with cross-functional teams to ensure compliant product launches and superior patient outcomes. Travel up to 20% may be required.

Qualifications

• Bachelor’s degree in Biomedical or Mechanical Engineering and 5+ years of experience (or equivalent combination of education and years of experience).
• Background in Medical Device, Aeronautics, Automotive or other highly regulated industry; ISO13485 knowledge preferred.
• Knowledge of technical writing quality and best practices.
• Basic knowledge of manufacturing processes: metrology, precision machining, grinding, product cleaning, sterilization.
• Microsoft Office Suite proficiency.

Responsibilities

• Participating in design and manufacturing reviews.
• Generating DFMEAs/UFMEAs and participating in risk analysis discussions.
• Develop inspection strategy and methods to support development and launch of new products.
• Reviewing and approving design and development documentation.
• Serve as SME 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.
• Ensuring compliance to internal and external specifications and standards (ISO, FDA).
• Reviewing trends in device failures and customer complaints.
• Leading corrective and preventive actions and complaint investigations.
• Working on complex special projects.

Skills

5+ years experience

Regulatory quality

Microsoft Office

Education

Bachelor's degree in Biomedical or Mechanical Engineering

Tools

Solidworks

Solidworks ePDM

MiniTab

Netsuite

Agile PLM

CMM

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 pay attention to the details. We embrace collaboration with our partners and patients and take pride in the pursuit 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. Why work at Enovis? See for yourself. As a key member of the Foot & Ankle Quality NPI 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.

Key Responsibilities

• Participating in design and manufacturing reviews.
• Generating DFMEAs/UFMEAs and participating in risk analysis discussions.
• Develop inspection strategy and methods to support the development and launch of new products.
• 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 and complaint investigations.
• Working on complex special projects as assigned.

Minimum Basic Qualifications

• Bachelor’s degree in Biomedical or Mechanical Engineering and 5+ years of experience (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 20%

Desired Characteristics

• Advanced knowledge of ISO 14971 and risk management principles.
• Experience with Class II/III Medical Devices.
• Preferred knowledge of the following:
• Solidworks
• Solidworks ePDM
• MiniTab
• Netsuite
• Agile PLM
• CMM and/or automated inspection system programming.
• Prefer CQE, Lean, or 6 Sigma Certification.
• Detail oriented and analytical

Base Pay Range

Base Pay Range: $86,520 - $94,760 - $104,174 (reflective of a full-time position)

Benefits

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Spending and Savings Accounts
• 401(k) Plan
• Vacation, Sick Leave, and Holidays
• Income Protection Plans
• Discounted Insurance Rates
• Legal Services

Employees in this position are also eligible to earn an annual performance bonus. “Creating better together”. It’s the Enovis purpose, and it’s what drives us and empowers us every day on a global scale. We know that the power to create better – for our customers, our team members, and our shareholders – begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

What does creating better together mean to us at Enovis? Discover the “why” behind our purpose, values and behaviors: Our Enovis Purpose, Values and Behaviors on Vimeo

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.

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.