Quality Engineer
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- asking the right questions, anticipating potential problems, and helping engineering teams turn promising designs into reliable products. This is an opportunity to have a voice in development decisions and see the impact of your work as products move toward launch. Your primary focus will be new product development, with additional involvement in improving existing devices and resolving product issues. Someone with a strong mechanical foundation who enjoys collaborating across teams could really thrive here. What your day could look like:
• Work alongside product development engineers to identify quality considerations early and keep projects moving through key milestones.
• Review product requirements, engineering documentation, and test plans to confirm that expectations are clear and supported by evidence.
• Help teams identify how a design or manufacturing process could fail, assess the risks, and establish appropriate safeguards.
• Connect product requirements with testing and risk controls so the team can demonstrate that the finished device performs as intended.
• Partner with manufacturing and supplier teams to prepare new designs and components for production.
• Assess proposed product changes and help investigate performance concerns, determine root causes, and implement lasting improvements. The experience that would make you a strong fit:
• A bachelor’s degree in Mechanical Engineering or a related engineering field.
• Medical device quality engineering or design assurance experience, including direct involvement in developing and launching new products.
• A practical understanding of design controls, verification and validation, and risk management tools such as DFMEA and PFMEA.
• Familiarity with mechanical components, assemblies, manufacturing methods, and product reliability.
• Experience working within an ISO 13485 quality system and applying relevant FDA requirements.
• The ability to explain technical concerns clearly, write thorough documentation, and work collaboratively with engineers across disciplines. Experience with implantable devices, ISO 14971, process validation, or supplier quality would be especially valuable. A background in a startup or growing medical device organization is also a plus Interested in a role where you can influence how a product is built from the beginning? Apply or share this with someone who might be a great fit
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