Senior Design Quality Engineer (Mansfield, MA)

Smith & Nephew•Mansfield, MA

3d•Hybrid

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Do you want to work in a collaborative environment that promotes innovation while prioritizing care for each other and our patients? Do you want to develop products that will enable friends and family to live life unlimited? If so, join our Smith+Nephew team as a Senior Design Quality Engineer and be part of a cross-functional team responsible for New Product Development for sports medicine joint repair products. This position is not offering any type of visa transfer or sponsorship now or in the future. A Senior Design Quality Engineer will be part of a cross-functional team for new product development to deliver safe and effective products to the market by ensuring all aspects of design controls are robust and comply with company polices and governmental regulations.

Requirements

Bachelor of Science in Engineering or technically related field
+5 years experience in the pharmaceutical/medical device industry or related regulated industry.
FDA QSR, ISO 13485, ISO 14971, strong collaboration and communication.

Nice To Haves

CQE or Six Sigma preferred

Responsibilities

Design quality engineer on new product development cross-functional core team.
Responsible for leading risk management planning, use/design failure mode effects analysis (FMEA), risk control and mitigation and verification of effectiveness.
Responsible for leading quality design transfer activities including test method validation / measurement systems analysis and incoming inspection.
Support other design transfer activities, including process validations, master validation plans, process summaries, and process failure mode effects analysis (FMEA).
Responsible for development and release of engineering design documentation, support core team during design reviews and support design history file compilation/audit activities.
Provide quality input to product user needs, design inputs, design specifications and design outputs (including analysis/definition of critical to quality features).
Support design verification testing, design validation and usability testing.
Attend cadaveric labs with customers (sales, marketing, surgeons) to build understanding of user needs and conduct design validation/usability.
Assists in preparation for regulatory submissions and support sustaining quality with defending design control elements during internal and external audits.
Includes leading design control gap assessments (DHF audits).
Leads identification and implementation of process improvement initiatives which require cross-functional and multi-site collaboration.
Works cross-functionally to influence key stakeholders and provides training, leadership, and mentorship to teams and junior engineers.