Michael Page
Design Quality Engineer- Medical Device- Greater Boston
Michael Page, Boston Heights, Ohio, United States
Design Quality Engineer- Medical Device- Greater Boston
This range is provided by Michael Page. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$88,000.00/yr - $115,000.00/yr We are seeking a Design Quality Engineer to join a medical device/regulated‑industry team. In this role, you will help ensure that products meet safety, regulatory, and business requirements throughout the design lifecycle. You will work closely with cross‑functional teams on both new product development and sustaining projects of complex electromechanical systems (with software and disposables). They\'re a medical‑technology firm developing a portable system to preserve and assess donor organs using perfusion, not cold storage, thereby increasing the usable organ pool and improving transplant outcomes. They also operate a nationwide logistics and clinical service network to support organ transport and transplantation programs. Description
Ensure design control processes comply with relevant regulatory, corporate, and customer quality standards Collaborate with engineering, manufacturing, project management, regulatory, and other functions Provide quality input during development of user needs, requirements, and specifications Define critical-to-quality specifications and support traceability Support creation of design documentation, test plans, test cases, protocols, reports, and execute verification/validation Participate in design reviews and maintain design history files Lead and support risk management (FMEAs, hazard analyses, risk control, verification of mitigation) Support design transfer activities into manufacturing Assist with regulatory submission preparation, audit/inspection support Lead or support root‑cause investigations, CAPA, process improvements, and SOP updates Advocate continuous improvement in quality systems, statistics, and verification/validation practices Profile
A background in engineering, manufacturing, or a related field with a focus on quality assurance. Strong understanding of quality standards and regulatory compliance in the business services industry. Excellent problem-solving skills and attention to detail. Ability to work collaboratively within cross-functional teams. Proficiency in quality management tools and systems. Job Offer
If you are passionate about quality assurance and want to make a difference in the business services industry, apply now for this exciting opportunity in Boston! MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual\'s status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. Seniority level
Entry level Employment type
Full-time Job function
Quality Assurance Industries
Medical Equipment Manufacturing
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This range is provided by Michael Page. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$88,000.00/yr - $115,000.00/yr We are seeking a Design Quality Engineer to join a medical device/regulated‑industry team. In this role, you will help ensure that products meet safety, regulatory, and business requirements throughout the design lifecycle. You will work closely with cross‑functional teams on both new product development and sustaining projects of complex electromechanical systems (with software and disposables). They\'re a medical‑technology firm developing a portable system to preserve and assess donor organs using perfusion, not cold storage, thereby increasing the usable organ pool and improving transplant outcomes. They also operate a nationwide logistics and clinical service network to support organ transport and transplantation programs. Description
Ensure design control processes comply with relevant regulatory, corporate, and customer quality standards Collaborate with engineering, manufacturing, project management, regulatory, and other functions Provide quality input during development of user needs, requirements, and specifications Define critical-to-quality specifications and support traceability Support creation of design documentation, test plans, test cases, protocols, reports, and execute verification/validation Participate in design reviews and maintain design history files Lead and support risk management (FMEAs, hazard analyses, risk control, verification of mitigation) Support design transfer activities into manufacturing Assist with regulatory submission preparation, audit/inspection support Lead or support root‑cause investigations, CAPA, process improvements, and SOP updates Advocate continuous improvement in quality systems, statistics, and verification/validation practices Profile
A background in engineering, manufacturing, or a related field with a focus on quality assurance. Strong understanding of quality standards and regulatory compliance in the business services industry. Excellent problem-solving skills and attention to detail. Ability to work collaboratively within cross-functional teams. Proficiency in quality management tools and systems. Job Offer
If you are passionate about quality assurance and want to make a difference in the business services industry, apply now for this exciting opportunity in Boston! MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual\'s status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. Seniority level
Entry level Employment type
Full-time Job function
Quality Assurance Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr