Team Lead, Design Assurance

Position Summary

Provide entry-level leadership for quality and design assurance activities related to the support of new product development and sustaining engineering up to and including technology transfer and commercialization. Supervise the activities and manage the performance of design assurance and other quality engineering staff. Provide hands-on support for R&D and Sustaining Engineering projects as needed, while supporting broader business unit objectives and global strategic initiatives.

Principal Responsibilities

1.    Supervise design assurance and other quality engineering personnel. Provide feedback on employee job performance. Conduct performance reviews and recommend personal and professional growth opportunities.

2.    Recruit, hire, onboard, and ensure the training of department additions to address resource needs.
3.    Oversee design assurance activities involved with new product development and improvement, including product and process design, classification of quality characteristics, design inputs and review, technical drawings and specifications, and design verification and validation.
4.    Participate in strategic planning and in the formation of department policies, procedures, organizational structure, and direction.
5.    Identify, track and respond to metrics relevant to the department's performance.
6.    Interact with senior management and engineering personnel to help establish priorities, allocate personnel, define project objectives and determine target completion dates.
7.    Provide subject matter expertise and technical leadership in best-practice quality, reliability, design control, statistics, and risk management tools and techniques throughout all stages of our products' life cycle.
8.    Lead and/or support the development of risk management documentation such as risk analyses, FMEAs, and post-market surveillance documents. 

9.    Support aspects of the company's improvement, remediation, and compliance projects including external quality system implementation and maintenance.

10.    Contribute, as necessary, to R&D projects as the lead Design Assurance Quality Engineer. Participate in design and technical reviews as required.
11.    Determine and review product and process testing methodologies and results to ensure reliability. 
12.    Support the establishment of design limits for new and modified products and the identification of essential design outputs.
13.    Champion continuous improvement of manufacturing processes and equipment through lean manufacturing techniques and statistical analysis such as Gage R&R, process capability studies, DOE, and SPC.
14.    Work with counterparts in other business units to implement technical and managerial best practices.
15.    Own, support, and/or approve CAPAs or CAPA phases, NCs, and other corrective action and improvement efforts as required.
16.    Apply project management skills in cost/schedule/resource planning as appropriate and assist others in doing the same.
17.    Ensure compliance to the quality management system as well as national and international standards and regulations.
18.    Review and, as appropriate, modify quality system records and documents to ensure compliance and effectiveness.
19.    Defend the compliance of the department's processes and records during internal and external audits.

Education / Experience Requirements

•    B.A. or B.S. degree in a technical discipline, such as engineering or science (equivalent experience may be considered). 
•    Recommended 3-5 years of quality engineering or design assurance experience (preferably in the medical device industry).  

Specialized Skills / Other Requirements

•    ASQ certification preferred (e.g. CQE, CQA, CMDA, CRE, CSSGB/CSSBB). 
•    Ability to train, mentor, and coach others.
•    Thorough understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820.
•    Proficient in MS Office, and Minitab or other statistical softwares.
•    Strong organizational and time management skills to meet deadlines while managing multiple projects.
•    Strong analytical and critical thinking skills.
•    Proficient in technical report writing and review.
•    Strong verbal and written communication skills. 
•    Foster a positive culture of growth, collaboration, adaptability to change, and achievement.