New Product Development Supplier and Quality Engineer

  • Anywhere

Company :

Location :
Phoenix, Arizona

Expiry Date :
Mon, 14 Jun 2021 23:59:59 GMT

Apply Job :
Open Link

Description :
New Product Development Supplier and Quality Engineer Engineer/Scientist North America-United States-Arizona-Phoenix North America-United States-Arizona-Flagstaff 20% Full-time About Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates. About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. About the Role: We are looking for an New Product Development (NPD) Supplier Engineer to join our External Design and Operations team in Arizona who will ensure that R & D, Manufacturing and other functions receive the maximum value from supplier engagements to meet MPD’s business objectives, and own the integration of supplier NPD deliverables with the GORE Quality Management System (QMS). Responsibilities: Accountable for building and maintaining the supplier relationship at both the team and executive levels; act as first line of escalation to supplier in coordination with Supplier Account Manager Represent supply chain on a New Product Development Core Team Ensure product design requirements are met by owning quality engineering design control deliverables and maintaining product Design History Files (i.e. Design input/output documentation, Risk management tools), including technical review of supplier documentation Ensure continued compliance to ISO and other global quality standards/ guidelines for product design and performance, addressing ERT, PERC and other documentation gaps/updates Employ statistical techniques to promote data driven decisions to establish sampling plans/troubleshoot/drive continuous improvement Ensure critical business goals are addressed, and capabilities are in place at the supplier to meet the product specifications/requirements. This includes cost, quality/design assurance, capacity, delivery, and any technology transfer Responsible for communicating project updates, needs and tasks to the broader Supply Chain organization Responsible for and ensuring cost modeling (SCM) is accurate and incorporated into Supply Chain decision making Ensure supplier regular (monthly) report out on project progress to executive leadership at both the supplier and Gore Identify high-risk suppliers and align stakeholders on recommendations and execution required for risk mitigation plans; supporting closing of technical risk mitigation plans Support routine audits and system work to maintain suppliers at qualified status Required Qualifications: Minimum 7 years engineering experience including minimum 2 years from the medical device industry Demonstrated ability to provide medical device product quality engineering or design assurance engineering Working knowledge of 21 CRF Part 820, ISO 13485, and ISO 14971 Demonstrated skills in Critical Thinking, Problem Solving, Statistics Excellent verbal and written communication skills MS Office and MS Project proficiency Demonstrated ability to partner within internal and external teams Demonstrated ability to successfully manage multiple priorities Ability to travel up to 20% domestically and internationally Desired Qualifications: Experience supporting early stage/new product development Demonstrated skills in project management Demonstrated ability to establish clear supplier expectations, and fairly address any gaps in suppliers’ deliverables What We Offer: At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits. Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, health & well-being program with full health plan, and a flexible working program. Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development. Learn more at We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect. Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description. Gore is a M/F, Disabled and Vet EEO/AA employer. (Applies to all positions in the U.S.) Our Talent Acquisition Team welcomes your questions at