Design assurance engineer

About the role:
The Design Assurance Engineer/ Assistant is a quality member that directly supports medical device
product development from concept through commercialization. You will support product sustaining
activities assessing product performance for trends including complaints and signal escalations. This
position will help lead, communicate, and coordinate complaint reduction and post market projects and
initiatives. Also, you will guarantee compliance with Quality System Regulations, Corporate Quality
Manual and corporate and local standard operating procedures.
Your Responsibilities Include:
• Collaborate to solve complex engineering problems using analysis, experimentation, and
statistics.
• Apply sound, systematic problem-solving methodologies in prioritizing, communicating, and
helping resolving quality issues (i.e. 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving
methodologies).
• Basic conceptual knowledge of Design Controls. Assist to project teams for project decisions and
deliverables (i.e. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design
Reviews, Design V&V, Usability Testing, Process Validation and Labeling).
• Create, maintain and/or support safety risk management processes, including Hazard Analysis,
Fault Tree Analysis, Task and Use Error Analysis, Risk Management Plan, Risk Management Report,
and DFMEA.
• Collaborate with quality trending using the complaint and NCEP/CAPA systems.
• Assist, communicate, and coordinate complaint reduction and post market projects and initiatives
and roll-out with cross-functional teams.
• Communicate product performance by formal presentations to management, cross-functional
team members, committees and/or design teams, supporting published product performance
reports.
• Support collection and analysis of key quality trending information and data for Management
Review and Complaint Reviews. Understand and support linkage of field data and Risk
Management.
• Assist during project decisions on quality and compliance inputs for post market product
sustaining activities, such as design changes, design concessions, product CE marking and safety
certification, customer complaint investigations, NCEP’s, CAPA’s PIRs, Field Signals Evaluations
and Field Actions.
• Contribute with internal and external regulatory audits, as required.
• Cooperate and contribute to developing test method validation protocols and reports, and design
verification activities.
• Work with cross functional teams to efficiently qualify new components; assist suppliers in
creating of statistical sampling plans, inspection methodology and quality procedures for new
components.
What we're looking for:
• Bachelor or Licentiate near-graduates in Chemical, Mechanical, Mechatronics, Materials,
Biomedical Engineering or related.
• English Level desired: 85-95%.
• Experience: 0 - 2 years
• Desired knowledge: Problem Solving, critical thinking, statistical tools.
• Ability to collaborate across multiple and cross-functional teams.
• Strong ability to multi-task and be adaptable.
Preferred Qualifications
• Strong presentation and facilitation skills.
• Experience with and/or knowledgeable in Quality System Regulations, Medical Device Regulation,
and Quality Standards.
• Demonstrated understanding of risk management.

Profesional

Bachillerato universitario

Ingeniería de Sistemas

Ingeniería Eléctrica - Electromecánica Electrónica y Mecatrónica

1 año de experiencia

1 Vacante