Global Mgr New Product Development Quality (Remote))

TE Connectivity

Location: Minneapolis, Minnesota

Job Type: Full time

Posted


At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.

Job Overview

The Global Quality NPD Manager is responsible for the leadership of the TE Medical NPD team. This includes responsibility for ensuring full compliance with the applicable FDA QSRs, ISO 13485 and Medical Device Regulation requirements for the Devices, Metals and Interconnect businesses across the entire TE Medical network. The Global Quality NPD Manager will play a critical leadership function in the NPD process and provide strategic quality direction for the product lifecycle management / improvement process. Key business partners for this role will be the Product Management, PMO, Engineering and Operations teams.


Duties & Responsibilities:

  • Provide leadership for quality activities associated with NPD and expand quality system tools and procedures to support NPD Gate Processes.
  • Define corporate quality system improvement strategies for NPD processes and drive implementation.
  • Provide quality leadership for LeanPD flow down and specification development.
  • Lead risk analysis activities for NPD programs and drive completion of appropriate mitigation.
  • Provide quality leadership for design review activities and launch readiness decisions.
  • Promote process capability and incorporation of Lean manufacturing concepts in process design.
  • Promote analytical problem solving through sound statistical application; provide organizational training.
  • Act as a global Subject Matter Expert for areas of Medical Device NPD.
  • Ensure the provision of NPD Quality Engineering to the Design Services group to ensure products are developed and manufacturing to the quality requirements.
  • Ensure that appropriate NPD processes are in place to ensure the appropriate requirements are met to support new product design and launch, and that this rigor continues through the product lifecycle.
  • Develop, track, and report on the following administrative systems: Department metrics, objectives, personnel development and training.
  • Support regulatory agency and customer quality audits as required.
  • As required, lead cross-functional/cross-site teams to support resolution of product and/or process related issues or objectives.
  • Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations as well as applicable QSR / ISO13485 / CMDCAS / EU MDR Standards.
  • Manage personnel to develop talent and enhance engagement to improve business performance.
  • As required by the business, participate in global and/or business-related projects ensuring the requirements of Quality and NPD are understood and considered when establishing strategy or planning/completing execution.
  • Support sites who are establishing NPD capability to ensure the appropriate standards are met, processes are in place and there is full understanding of the requirements. This will include formal training, ad-hoc advising, and on-going coaching.

TRAVEL: This position may require 10~25% travel to other sites, customer and supplier locations as required, and dependent on the needs of the organization.

What your background should look like:

Education/Experience/Key Requirements:

  • Degree with a scientific or engineering emphasis required. Bachelor of Science degree in mechanical, electrical, chemical, or material science engineering. BS in Applied Sciences (math, chemistry, physics, etc.) may be considered depending on experience.
  • 7-10+ years of quality/process engineering with a minimum of 3-5 years of New Product Development experience. Greater than 5 years industrial experience in which candidate had responsibility for the development and implementation of product and/or process quality.
  • Experience should include Design.
  • Assurance management within finished medical device organization(s).
  • Very strong knowledge of the regulatory requirements required to support Medical Device design, commercialization and change management.
  • Candidate must have demonstrated quality leadership and people management skills plus exhibit strong interpersonal and communication skills.
  • Candidate must be able to influence team dynamics regarding quality goals, deliver constructive feedback and provide quality leadership in a cross functional environment.
  • Candidate must have experience with CTQ development, validation plan construction, risk analysis, reliability, design and process validation testing, stack up tolerance analysis, gauge design, control plan construction and standard work development
  • Candidate must have solid understanding of statistical methods and their application to product or process engineering. Strong analytical and critical thinking skills are a must. The candidate must have experience with typical quality gauges and instrumentation plus understand engineering drawings. Proficiency with Excel, Minitab, Access and PowerPoint is expected.
  • Highly motivated with a sense of urgency.
  • Preferred candidate will have experience in Lean/Six Sigma tools and manufacturing techniques. CQE, CQM and / or Black Belt in Lean or Six Sigma preferred.

Competencies

Managing and Measuring Work
Motivating Others
Building Effective Teams
Values: Integrity, Accountability, Teamwork, Innovation
SET : Strategy, Execution, Talent (for managers)

ABOUT TE CONNECTIVITY
TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications and the home. With approximately 80,000 employees, including more than 7,500 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.

COMPENSATION

  • Competitive base salary commensurate with experience: $125K-$155K (subject to change dependent on physical location)
  • Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
  • Total Compensation = Base Salary + Incentive(s) + Benefits
BENEFITS
  • A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.

EOE, Including Disability/Vets

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