NPI Quality Engineer

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation & Holidays

Income Protection Plans

Job summary

Enovis Corporation seeks a NPI Quality Engineer in Houston, TX to support New Product Development and complaint investigations. The role functions as QA on PD initiatives, leading risk analysis, DFMEAs/UFMEAs, and design control activities. Possession of a Biomedical or Mechanical Engineering degree with 5+ years in a regulated setting is required.

Travel up to 20% may be involved. Competitive base pay and annual bonus are offered.

Qualifications

• Bachelor’s degree in Biomedical or Mechanical Engineering; 5+ years of experience or equivalent combination.
• Background in Medical Device, Aeronautics, Automotive or other highly regulated industry.
• Knowledge of ISO13485 quality standards and quality system documentation.

Responsibilities

• Participating in design and manufacturing reviews.
• Generating DFMEAs/UFMEAs and participating in risk analysis discussions.
• Developing inspection strategy for new product development and launches.
• Reviewing and approving design and development documentation.
• Leading corrective and preventive actions and complaint investigations.

Skills

ISO 14971 knowledge

Quality systems

Education

Bachelor’s degree in Biomedical or Mechanical Engineering

Tools

Solidworks

Solidworks ePDM

MiniTab

Netsuite

Agile PLM

CMM

Job description

NPI Quality EngineerThis site uses cookies and other tracking technologies to provide you with our services, enhance the performance and functionality of our services, analyze the use of our products and services, and assist with our advertising and marketing efforts. To view the cookie policy, please click **here**.### NPI Quality EngineerApply: USA, Texas, Houston: Full time: Posted Today: R0034798## **Who We Are****ABOUT ENOVISTM**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 EnovisTM 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. **Job Title:** NPI Quality Engineer**Reports To:** Sr. NPI Quality Manager**Location:** Houston, TX**Business Unit Description:** Foot & Ankle **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, Sustaining Product Development, and Complaint Investigations 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* 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 ***Currently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.*** **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 *Enovis values the contribution each employee brings to our organization. The pay range listed is what we reasonably and in good faith expect to compensate candidates who meet the specified qualifications and requirements for this role. Actual starting pay will depend on various factors, including but not limited to education and experience in the job and/or industry.* *Base Pay Range*: $86,520 - $94,760 - $104,174 *(reflective of a full-time position)* *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 We offer a comprehensive benefits package that includes:* 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 Join us in creating better together.**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.