INSPYR
Overview
Title:
Quality/Design Controls Engineer
Location:
Remote
Duration:
Contract
Salary:
$50-60 hr
Work Requirements:
US Citizen, GC Holders or Authorized to Work in the U.S.
Job Description Design Controls Engineer (Contract)
What Youll Do
Establish and own Our company's Design & Development procedures (ISO 13485 §7.3), including templates for Design Plans, Design Inputs/Outputs, Reviews, and Design History Files (DHFs) for Hardware and Software
Lead cross-functional design reviews across hardware, software, and material development teams; ensure risk, validation, and change control are integrated.
Develop and maintain DHFs, DMRs, and MDFs for scanner systems, inks, and associated digital design software.
Drive risk management activities per ISO 14971, integrating hazard analysis, FMEAs, and risk traceability.
Author and review verification and validation protocols/reports, including equipment qualifications (IQ/OQ/PQ), material validation, and software lifecycle documentation (per IEC 62304).
Establish Design Transfer protocols, linking development to manufacturing and ensuring traceability through BOMs, DHRs, and process validation.
Coach internal teams on design control expectations for both SaMD (software as a medical device) and hardware components.
Support audits and submissions, providing SME input on design controls, risk management, and technical files.
Implement document and record management structure for all design records in the QMS (Dot Compliance).
What Were Looking For
Experience in medical device, dental device, or life sciences industries with a focus on design controls, new product development, and process validation.
Proven track record of building design control frameworks from the ground up (startups or greenfield environments preferred).
Deep knowledge of ISO 13485, FDA 21 CFR 820, MDSAP, ISO 14971, and IEC 62304 (software lifecycle).
Strong experience with hardware and material design verification (scanner systems, inks, or similar digital manufacturing devices).
Experience leading design and risk reviews, authoring Design History Files (DHF), Risk Management Files (RMF), and validation documentation.
Experience with SaMD classification, validation, and regulatory documentation is a must.
Excellent organizational and communication skills; able to bridge quality, engineering, and product teams effectively.
ASQ CQE/CQA, Six Sigma Black Belt, or ISO 13485 Lead Auditor certification preferred.
About INSPYR Solutions Technology is our focus and quality is our commitment. As a national expert in delivering flexible technology and talent solutions, we strategically align industry and technical expertise with our clients' business objectives and cultural needs. Our solutions are tailored to each client and include a wide variety of professional services, project, and talent solutions. By always striving for excellence and focusing on the human aspect of our business, we work seamlessly with our talent and clients to match the right solutions to the right opportunities. Learn more about us at inspyrsolutions.com.
EEO Policy INSPYR Solutions provides Equal Employment Opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, INSPYR Solutions complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.
Privacy and Consent Information collected and processed through your application with INSPYR Solutions (including any job applications you choose to submit) is subject to INSPYR Solutions’ Privacy Policy and INSPYR Solutions’ AI and Automated Employment Decision Tool Policy: https://www.inspyrsolutions.com/policies/. By submitting an application, you are consenting to being contacted by INSPYR Solutions through phone, email, or text.
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Quality/Design Controls Engineer
Location:
Remote
Duration:
Contract
Salary:
$50-60 hr
Work Requirements:
US Citizen, GC Holders or Authorized to Work in the U.S.
Job Description Design Controls Engineer (Contract)
What Youll Do
Establish and own Our company's Design & Development procedures (ISO 13485 §7.3), including templates for Design Plans, Design Inputs/Outputs, Reviews, and Design History Files (DHFs) for Hardware and Software
Lead cross-functional design reviews across hardware, software, and material development teams; ensure risk, validation, and change control are integrated.
Develop and maintain DHFs, DMRs, and MDFs for scanner systems, inks, and associated digital design software.
Drive risk management activities per ISO 14971, integrating hazard analysis, FMEAs, and risk traceability.
Author and review verification and validation protocols/reports, including equipment qualifications (IQ/OQ/PQ), material validation, and software lifecycle documentation (per IEC 62304).
Establish Design Transfer protocols, linking development to manufacturing and ensuring traceability through BOMs, DHRs, and process validation.
Coach internal teams on design control expectations for both SaMD (software as a medical device) and hardware components.
Support audits and submissions, providing SME input on design controls, risk management, and technical files.
Implement document and record management structure for all design records in the QMS (Dot Compliance).
What Were Looking For
Experience in medical device, dental device, or life sciences industries with a focus on design controls, new product development, and process validation.
Proven track record of building design control frameworks from the ground up (startups or greenfield environments preferred).
Deep knowledge of ISO 13485, FDA 21 CFR 820, MDSAP, ISO 14971, and IEC 62304 (software lifecycle).
Strong experience with hardware and material design verification (scanner systems, inks, or similar digital manufacturing devices).
Experience leading design and risk reviews, authoring Design History Files (DHF), Risk Management Files (RMF), and validation documentation.
Experience with SaMD classification, validation, and regulatory documentation is a must.
Excellent organizational and communication skills; able to bridge quality, engineering, and product teams effectively.
ASQ CQE/CQA, Six Sigma Black Belt, or ISO 13485 Lead Auditor certification preferred.
About INSPYR Solutions Technology is our focus and quality is our commitment. As a national expert in delivering flexible technology and talent solutions, we strategically align industry and technical expertise with our clients' business objectives and cultural needs. Our solutions are tailored to each client and include a wide variety of professional services, project, and talent solutions. By always striving for excellence and focusing on the human aspect of our business, we work seamlessly with our talent and clients to match the right solutions to the right opportunities. Learn more about us at inspyrsolutions.com.
EEO Policy INSPYR Solutions provides Equal Employment Opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, INSPYR Solutions complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.
Privacy and Consent Information collected and processed through your application with INSPYR Solutions (including any job applications you choose to submit) is subject to INSPYR Solutions’ Privacy Policy and INSPYR Solutions’ AI and Automated Employment Decision Tool Policy: https://www.inspyrsolutions.com/policies/. By submitting an application, you are consenting to being contacted by INSPYR Solutions through phone, email, or text.
#J-18808-Ljbffr