Senior Design Quality Engineer (Mansfield, MA)

Smith+Nephew•Mansfield, MA

1d•$96,750 - $145,000•Onsite

About The Position

Smith+Nephew is seeking a Senior Design Quality Engineer to join their New Product Development team for sports medicine joint repair products. This role involves ensuring design controls are robust and comply with company policies and governmental regulations, contributing to the delivery of safe and effective products to the market. The position is part of a cross-functional team and requires collaboration to drive innovation and patient care.

Requirements

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

Nice To Haves

CQE or Six Sigma certification preferred.

Responsibilities

Serve as the design quality engineer on new product development cross-functional core teams.
Lead risk management planning, use/design failure mode effects analysis (FMEA), risk control and mitigation, and verification of effectiveness.
Lead quality design transfer activities, including test method validation/measurement systems analysis and incoming inspection.
Support other design transfer activities such as process validations, master validation plans, process summaries, and process failure mode effects analysis (FMEA).
Develop and release engineering design documentation.
Support the core team during design reviews and assist with 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 understand user needs and conduct design validation/usability.
Assist in preparing for regulatory submissions and support sustaining quality by defending design control elements during internal and external audits.
Lead design control gap assessments (DHF audits).
Lead the identification and implementation of process improvement initiatives requiring cross-functional and multi-site collaboration.
Work cross-functionally to influence key stakeholders and provide training, leadership, and mentorship to teams and junior engineers.