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Job Description
We are seeking a motivated
Design Quality Engineer
with a strong interest in supporting next- product development from concept through commercialization. This role is ideal for someone who thrives in a fast-paced, innovative, and cross-functional startup environment. You'll play a critical role in ensuring our electromechanical products meet regulatory, safety, and customer expectations. Key Responsibilities: Partner with R&D and cross-functional teams during
New Product Development (NPD)
to ensure quality is designed into the product from the beginning. Assist in the creation and review of
requirements specifications ,
risk management documents ,
design verification plans , and
test protocols/cases . Perform
hands-on testing
of products and prototypes to validate performance, safety, and reliability against specifications. Support
design reviews ,
design history file (DHF)
compilation, and other product development quality activities. Collaborate with suppliers to support incoming quality and component validation efforts (as needed). Help implement and maintain
design quality processes
in compliance with internal procedures and applicable regulations (e.g., ISO 13485, FDA QSR, etc.). Identify, communicate, and help mitigate design and process risks early in the development cycle. Qualifications: Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related field). 2–4 years of experience in a Design Quality, Product Development role within the Medical Device industry. Experience with
electromechanical systems
and/or
embedded software
is a strong plus. Familiarity with
quality tools and processes , such as FMEA, root cause analysis, verification & validation (V&V), etc. Ability to interpret engineering drawings, technical specifications, and test data. Soft Skills & Work Environment: Self-starter
with strong initiative and problem-solving ability. Clear communicator with a focus on
career growth and development . Comfortable working in a
start-up or dynamic environment
with evolving priorities. Collaborative mindset with the ability to contribute to cross-functional team success. What We Offer: Opportunity to work on a cutting-edge product with a passionate and talented team. Career development in a rapidly growing company. Exposure to the full product lifecycle and diverse engineering challenges. Competitive salary and benefits.
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Design Quality Engineer
with a strong interest in supporting next- product development from concept through commercialization. This role is ideal for someone who thrives in a fast-paced, innovative, and cross-functional startup environment. You'll play a critical role in ensuring our electromechanical products meet regulatory, safety, and customer expectations. Key Responsibilities: Partner with R&D and cross-functional teams during
New Product Development (NPD)
to ensure quality is designed into the product from the beginning. Assist in the creation and review of
requirements specifications ,
risk management documents ,
design verification plans , and
test protocols/cases . Perform
hands-on testing
of products and prototypes to validate performance, safety, and reliability against specifications. Support
design reviews ,
design history file (DHF)
compilation, and other product development quality activities. Collaborate with suppliers to support incoming quality and component validation efforts (as needed). Help implement and maintain
design quality processes
in compliance with internal procedures and applicable regulations (e.g., ISO 13485, FDA QSR, etc.). Identify, communicate, and help mitigate design and process risks early in the development cycle. Qualifications: Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related field). 2–4 years of experience in a Design Quality, Product Development role within the Medical Device industry. Experience with
electromechanical systems
and/or
embedded software
is a strong plus. Familiarity with
quality tools and processes , such as FMEA, root cause analysis, verification & validation (V&V), etc. Ability to interpret engineering drawings, technical specifications, and test data. Soft Skills & Work Environment: Self-starter
with strong initiative and problem-solving ability. Clear communicator with a focus on
career growth and development . Comfortable working in a
start-up or dynamic environment
with evolving priorities. Collaborative mindset with the ability to contribute to cross-functional team success. What We Offer: Opportunity to work on a cutting-edge product with a passionate and talented team. Career development in a rapidly growing company. Exposure to the full product lifecycle and diverse engineering challenges. Competitive salary and benefits.
#J-18808-Ljbffr