Design Quality engineer

Katalyst Talent Agency

Cambridge, MA, United States

3 months ago

Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Working hours

Regular working hours

Job source

indeed.com

Tech stack

Systems Engineering Failure Mode Effects Analysis Imaging Technology Software Engineering Jama (Software)

Job description

Responsible for ensuring compliance to design controls, risk management, and verification/validation activities across the product lifecycle for medical devices, with a strong preference for ultrasound/imaging systems.

Requirements

Do you have experience in Systems engineering?, Strong understanding of: Design controls & product lifecycle Systems engineering

Experience in:

DFMEA / risk analysis Requirement management tools (DOORS, Jama, etc.) V&V execution and review Regulatory & Standards Knowledge

Mandatory:

ISO 13485 ISO 14971

Preferred:

IEC 60601 (electrical safety) IEC 62304 (software lifecycle) IEC 62366 (usability) Ultrasound / Imaging Domain (Preferred)

Strong systems thinking Ability to:

Identify design gaps early Drive risk-based decisions

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Good distractions

Talks and stories from around this role — technically off-topic, practically not.

Moments

Explore playlists

4:08 min

Introduction to speakers and model-based systems engineering goals

Daniel Siegl +1 · LIVE

1:26 min

Asking critical engineering questions to prevent software defects

Lilia Gargouri · WWC Europe 2026

59 sec

Assessing tech pivots like Midjourney ultrasounds and browser micropayments

Chris Heilmann +1 · LIVE

1:13 min

Establishing shared vocabulary with Green Software Foundation principles

Pierre-Luc Noel +1 · WWC 2023

3:09 min

Balancing data science skillings alongside systems engineering rigor

Nico Schmidt · LIVE

1:51 min

Handling safety platforms and customer acceptance testing requirements

Anja Kunkel · WWC 2023

Videos

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Model Based Systems Engineering in an Agile Product Development Process thumbnail