Quality Engineer

Venture Hire Group LLC; San Diego (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Venture Hire Group LLC in San Diego is seeking a Quality Engineer to shape the next generation of medical device technology. You will engage early in development, ask critical questions, and help teams turn promising designs into launch-ready products.

You will focus on new product development, with involvement in improving existing devices and resolving issues. A strong mechanical foundation and collaboration across disciplines are essential to thrive.

Qualifications

• Bachelor’s degree in Mechanical Engineering or a related field.
• Medical device quality engineering or design assurance experience with development and launch of new products.
• Understanding of design controls, verification & 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 FDA requirements.

Responsibilities

• Identify quality considerations early with product development engineers.
• Review requirements, documentation, and test plans to confirm evidence.
• Assess risks and establish safeguards to prevent failures.
• Link product requirements to testing and risk controls to demonstrate device performance.
• Collaborate with manufacturing and supplier teams to prepare designs for production.
• Investigate performance issues, determine root causes, and implement lasting improvements.

Skills

Design controls

Verification & Validation

Risk management

DFMEA

PFMEA

ISO 13485

FDA regulatory knowledge

Education

Bachelor's degree in Mechanical Engineering

Job description

Help shape the next generation of medical device technology.

We’re partnering with an innovative medical device company seeking a Quality Engineer who enjoys being involved while products are still taking shape - 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.

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!