Design Quality Engineer (Alajuela, Costa Rica)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

A 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.

This position is a P2 level

What will you be doing?

Responsibilities include, but not limited to:

• 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. 

• 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).

• Assist in identification and implementation of process improvement initiatives which require cross-functional and multi-site collaboration.

What will you need to be successful?

Education: Bachelor of Science in Engineering or technically related field.
Experience: 2+ years of experience in the medical device or a related regulated industry, with proven experience in design verification, design validation, and usability testing.

Fluent English (C1) both written and spoken.

Competences: FDA QSR, ISO 13485, ISO 14971, strong collaboration and communication.

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion+belonging: Committed to Welcoming, Celebrating and Thriving, learn more about employee inclusion groups on our website

Other reasons why you will love it here!

• Your future:  stock purchase program, referral bonus, subsidy in transport and food, recognition program.

• Work/Life Balance: Extra days off, birthday off, voluntary hours.

• Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave. 

• Flexibility: Hybrid work model (for more professional roles), flexible schedules.

• Training: Training program, unlimited learning.

• Extra perks: employees association, and more…

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