Design Assurance Engineer

Job TitleDesign Assurance Engineer IIPay Rate$45 - $48/hourDuration3-4 monthsLocationHybrid; Minnetonka, MNTravelUp to 10% travel requiredPOSITION SUMMARYWe are seeking a Design Assurance Engineer II to lead quality engineering activities for development projects, from conception through commercialization. This role will involve developing risk management files, completing DHF deliverables, and providing significant input in design verification/validation. The Design Assurance Engineer II will ensure mechanical product designs meet quality, reliability, and regulatory standards.ESSENTIAL FUNCTIONS AND RESPONSIBILITIESDrive Product QualityLead mechanical product design quality, reliability, and regulatory compliance with industry standards.Lead Design Control DeliverablesOversee the on-time completion of design control deliverables and resolve any design quality issues.Risk ManagementDevelop and manage risk management files from product conception through commercialization.Product Testing PlansCreate release testing plans for new products and support testing for design verification/validation.Regulatory ComplianceEnsure design control and design history files (DHF) content is complete, accurate, and complies with relevant standards and regulations.Quality SystemsContribute to the development and improvement of quality systems.Specification and TestingSupport print specification definitions and design test method development and validation.Verification and ValidationLead design verification/validation and reliability study execution to ensure compliance with quality system regulations.OEM Manufacturing SupportEnsure on-time execution of quality plans for OEM manufacturing in development projects and design changes.Process DevelopmentSupport manufacturing process development and qualification for new product commercialization.Audit ParticipationAssist with internal and external audits and support complaint investigations as needed.CollaborationBuild strong relationships with cross-functional team members and partner organizations to ensure organizational success while protecting patient/user safety.EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIESEducationBachelor's degree in Engineering (Mechanical, Material Science, Biomedical) or related Science field.Experience3+ years of relevant experience in the medical device industry or a related function. An equivalent combination of experience and education may be considered.Skills and AbilitiesIn-depth knowledge of GMPISOQSR, and other relevant international regulations, standards, directives, and guidance.Strong statistical data analysis skills.Ability to manage multiple projects and prioritize effectively.Excellent verbal and written communication skills.Ability to work both independently and within a cross-functional team environmentCapability to educate stakeholders (customers, suppliers, and management) on design assurance principles.Customer-focused with a service-oriented mindset.Proactive problem-solving approach, willing to put ideas into action and partner with others to make a difference.PREFERRED/BENEFICIAL QUALIFICATIONSDesign for Six Sigma (DFSS) and Critical to Quality (CTQ) training and experience.Experience in sterile pharmaceutical products and drug-device combination products in development and commercial programs.Experience partnering with external organizations (customers and suppliers) to complete projects.Experience participating in auditsASQ certification is a plus.If you have a passion for quality engineering and want to make a significant impact in the medical device industry, we encourage you to apply for this exciting opportunity!EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.REQUESTING AN ACCOMODATIONSuna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 (888) 223-4788, send us an email or speak with your recruiter.PAY TRANSPARENCY POLICY STATEMENTCompensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington as set forth below.

Created: 2025-03-07