Job Title: Senior Design Assurance Engineer (3-Month Contract-to-Hire) Location: Minneapolis, MN Job Type: 3-Month Contract-to-Hire Position Overview: We are seeking an experienced Senior Design Assurance Engineer for a 3-month contract-to-hire position in Minneapolis, MN. This role offers an exciting opportunity to contribute to the development and validation of innovative medical devices in a collaborative, fast-paced environment. As a key member of the design assurance team, you will play a critical role in ensuring the safety, effectiveness, and regulatory compliance of medical device products. Key Responsibilities: + Lead and support design assurance activities throughout the product development lifecycle, ensuring compliance with regulatory standards (FDA, ISO, etc.). + Review and approve design documentation, including design control deliverables (Design Inputs, Design Outputs, Design Verification/Validation). + Provide guidance and support to cross-functional teams in the implementation of risk management processes (FMEA, Hazard Analysis, Risk Assessment). + Conduct and document risk management assessments and collaborate with product development teams to mitigate identified risks. + Support the creation and execution of design validation and verification protocols, ensuring adherence to quality and regulatory standards. + Participate in design reviews and provide expert feedback on product designs, including design transfer activities and design history file maintenance. + Work closely with quality assurance, regulatory, and manufacturing teams to ensure seamless transitions between design and production stages. + Contribute to the preparation for regulatory inspections, audits, and external assessments. + Ensure that design control documentation, test protocols, and reports meet FDA and ISO 13485 guidelines. Qualifications: + Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or related field (or equivalent experience). + 5+ years of experience in medical device design assurance, with a deep understanding of FDA and ISO 13485 regulatory requirements. + Proven experience working with design control processes, including design verification/validation, risk management, and design documentation. + Experience with regulatory submissions, audits, and inspections. + Strong understanding of risk management techniques (e.g., FMEA, Fault Tree Analysis). + Excellent communication and interpersonal skills, with the ability to work cross-functionally with diverse teams. + Ability to manage multiple projects in a fast-paced, dynamic environment. + Experience with quality management systems (QMS) and maintaining a design history file (DHF) is highly preferred. + Strong problem-solving skills, attention to detail, and the ability to anticipate and mitigate potential risks in the development process. Preferred Qualifications: + Experience with medical device combination products or active implantable devices. + Six Sigma or other process improvement certifications are a plus. Compensation: + $40-$65/hr. DOE + Potential for permanent placement the 3-month contract period. Powered by JazzHR