NPI QE Manager - Houston, United States - Enovis

Description

Job Description:

At EnovisTM 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 our 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.

As the NPI QE Manager with Enovis's Foot & Ankle division, you will develop, coach, and lead a team of NPI Quality Engineers to support and serve the R&D team, bringing safe and effective products to market. You will be responsible for establishing, updating, and owning Foot & Ankle new-product quality related objectives and processes. At Enovis quality is everyone's responsibility, and you will set the standard for how we build quality into our products, processes, and our people by being a player-coach within your team and with the cross-functional teams you support.

Essential Duties and Responsibilities:

The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.

• Lead the team of Quality NPI engineers to ensure they are supporting their cross functional team members by owning all Quality aspects of NPI projects (QMS and Business Processes).
• Be a player-coach by understanding, supporting, and owning the NPI Quality Engineering Project Responsibilities listed below.
• Understand and facilitate compliance with quality standards and procedures needed to bring new products to market.
• Ensure our quality standards and procedures are in compliance with internal or external specifications and standards such as GLP, GMP, ISO, etc.
• Partner and collaborate with mid- to senior-level management on behalf of the Quality organization to ensure your teams views are being heard and that the NPI cross functional teams are being adequately supported.
• Own project resourcing processes by allocating Quality NPI resources as appropriate, identifying any gaps in resources, training, or responsibilities, and communicating assignments and expectations to the team and to the Quality leadership team.
• Ability to support more than one new product development project in different development phases.
• Have a professional disposition which promotes a culture of quality, early in the development cycle and pushes quality upstream.
• Cleary and concisely communicate ideas, solutions, or issues with cross functional team and with leadership.
• Ability to drive decision making by listening to the team's inputs, asking the right questions, and driving to effective solutions.
• Hold groups and individuals accountable and committed by clearly stating needs and communicating priorities associated with project strategy, needs and tasks.

NPI Quality Engineering Project Responsibilities

• Project Activities
  • Owning the integrity and review of documents, promote healthy critical review process to ensure we are creating clear, concise, and unambiguous documentation.
  • Complete critical reviews and approvals of documentation providing feedback regarding industry best practices, QMS requirements, etc. Ensure documents and designs are aligned with our defined procedures.
  • Develop and own Quality strategies and timelines needed to bring new products to market. Effectively communicate to the cross functional teams the needs, requirements, and durations to completion.
  • Own the development and maintenance of state-of-the-art inspection methods to support the development and launch of new products.
  • Own DHF reviews during phase gates to ensure NPI projects comply with applicable design control regulations, company policies and procedures, and to close out projects, releasing product to market.
  • Participate in Design reviews, addressing or escalating any quality related concerns.
  • Partner with cross functional team to ensure the proper application of design controls, risk management, and the investigation/correction of design failures/challenges.
  • Participate in the design and development process, including labs and testing, to promote quality at the development level.
  • You may serve as the Quality Functional Lead throughout the life of the project, ensuring that all aspects of the Quality function are being covered either by you or the respective owners.
  • Partner with the functional leads on Design Specifications, Material and Product test plans, V&V activities by reviewing and approving each document collaboratively, ensuring objective evidence is available to support acceptance criteria.
• Design Transfer
  • Develop and own quality outcomes such as a Quality Control and Manufacturing Process Validation Plans, etc., in support of NPI processes and practices. Plans should be consistent with product classification, potential defect types, defect frequency, severity, patient/user risks, process capability, process controls, etc.
  • Assist in manufacturing transfer activities by supporting development, timeline execution, and closure of Quality related design transfer activities.
  • Own the development of inspection and testing methods, defining First Article Inspection (FAI) requirements and execution on behalf of internally or externally sourced product.
  • Support, review, and approve design transfer activities to ensure design quality performance are properly transferred for items such as Process Validations, Measurement System Analyses (MSA), and final verification activities.
  • Support the development and improvement of internal manufacturing processes for existing products.
  • Develop and own measurement systems/capabilities, destructive tests, non-destructive tests, and CMM programming for manufacturing processes. Assess effectiveness of measurement tools, destructive tests, non-destructive tests, and measurement system analysis.
• Cross Functional Project Team
  • Be an active team member within projects assigned via quality leadership and the F&A project resourcing process.
  • Attend and support project team meetings, collaboration sessions and other collaboration activities.
  • Ensure quality requirements are clearly defined and integrated into project schedules.
  • Work cross functionally with Marketing, R&D, Regulatory, Manufacturing, etc. to ensure new products meet our quality standards.
  • Represent and communicate QA interests and best practices within the definition and scoping phases of projects.
  • Provide guidance on quality-related concerns and offer suggestions to overcome. If quality related concerns are not being addressed appropriately, escalate the concern to ensure it is addressed.
• Supplier onboarding
  • Coordinate with sourcing to lead NPI Supplier Quality Engineering (SQE) activities. Manage and prioritize Supplier onboarding activities and schedules for NPI projects with Supply Quality team.
  • Own communication and collaboration with respect to all new supplier onboarding and monitoring activities for NPI. Including but not limited to SQA development, processing and dispositioning supplier change requests, non-conformances, and internal metric KPI's/reporting.
• Documentation
  • Contribute to, review, and approve Risk Management activities for assigned products and projects, coordinating development and implementation of risk management plans, hazard analysis, design and process failures modes and effects analyses.
  • Contribute to, review and approve dFMEAs and pFMEAs documents required to develop and ensure new products assess all potential risks to our customers, patients, and users.
  • Develop and own nonconformance and complaint trend reports to support risk management file creation, updates, and continual monitoring.
  • Own the evaluation of legacy products for relevant quality issues that may impact product development projects.
  • Lead and own corrective and preventative actions associated with NPI projects.
  • Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to project team and leadership.
  • Present risks associated with the product use during Design Reviews, and track risk through design, documentation, and manufacturing processes to mitigate those issues throughout the development process.
  • Lead the investigation and resolution of nonconformances associated with the new product development process. When applicable, work with cross functional members to implement corrective actions to prevent issue recurrence. Leverage QC/QA scrap and RMA rates as applicable to initiate investigations.
  • Use statistical analysis techniques to establish product acceptance levels, sampling, and supporting evidence within validations, testing and verification activities.
• Other
  • Support Sustaining Quality Engineers by learning from the issues they face while maintaining legacy product and work to improve our processes, procedures, and products during the NPI process.

Required Education and Experience:

• Bachelor's degree in Engineering or similar discipline; equivalent combination of education and experience may be considered.
• 5+ years of Quality Engineering experience in medical technology
• 2+ years leading a team preferred
• Experience with NPI/NPD Quality Engineering and Design Controls
• Experience with Risk Management (ISO and dFMEAs
• Experience with design transfer from R&D into manufacturing and experience working on design changes
• Competency in Microsoft office suite (Word, Excel, PowerPoint, etc), SolidWorks, SolidWorks PDM, and statistical software applications such as Minitab.
• Demonstrated familiarity with gauging methods, techniques and strategies such as attribute and variable gages, CMM programming, tolerance application and metrology equipment.
• Gage design experience is beneficial.
• Inspection experience is beneficial.
• Manufacturing experience is beneficial.

"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.

Watch this short video and discover what creating better together means to us at Enovis:

Our Enovis Purpose, Values and Behaviors on Vimeo

We offer a comprehensive benefits package which 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

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. Visit to learn more.

EQUAL EMPLOYMENT OPPORTUNITY:

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and 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 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

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.