<p>> Position: Senior Quality Design Assurance Engineer Location: Eden Prairie, MN</p> <p>Job Id: 177 # of Openings: 1</p> <p>Job Title:</p> <p>Senior Quality Design Assurance Engineer</p> <p>Department:</p> <p>Quality</p> <p>Reports to:</p> <p>Quality Manager</p> <p>Work Location:</p> <p>In-Person</p> <p>Pay Range:</p> <p>100,000.00 to 115,000.00 Salary - Based on Experience</p> <p>Position Type and Expected Hours of Work:</p> <p>Full-Time, Monday-Friday, 40 hours/week</p> <p>About Elucent Medical:</p> <p>Elucent Medical is a medical device company focused on developing surgical navigation technologies, particularly for cancer surgery, to improve patient outcomes through precision and efficacy. The company's solutions are designed to transform traditional surgical instruments into "smart" tools, enhancing surgical precision and patient outcomes.</p> <p>Job Summary:</p> <p>The Sr. Quality Design Assurance Engineer is responsible for supporting product development through the creation, review and analysis of technical data, development and validation of test methods, and preparation of design documentation in accordance with current regulatory and industry standards. Key responsibilities include authoring and maintaining documents such as DFMEAs, Design History Files and verification/validation protocols and reports. This role also involves reviewing customer and product requirements to ensure they are adequately addressed in the design. The engineer ensures that all quality documentation complies with applicable regulations, including FDA Quality Management System Regulation (21 CFR Part 820) and ISO 13485. Additional responsibilities may be assigned as needed.</p> <p>Supervisory Responsibilities:</p> <p>None</p> <p>Job Responsibilities:</p> <p>Development Experience</p> <p>Provide leadership during design activities, including design reviews and preparation of technical documentation.</p> <p>Evaluate the impact to design, quality and regulatory functions regarding customer product requirements for Elucent development projects.</p> <p>Apply appropriate development tools and methodologies to support successful phase reviews</p> <p>Contribute to creation, maintenance, and improvement of design process documentation.</p> <p>Participate in product validation and verification activities in accordance with internal and external design control requirements.</p> <p>Lead or support risk management activities throughout the product development lifecycle.</p> <p>Quality and Regulatory Compliance</p> <p>Actively plan and conduct an analysis of the product development cycle to identify opportunities for process improvement and efficiency.</p> <p>Collaborate with Regulatory Affairs to ensure compliance throughout the product lifecycle, from design through manufacturing.</p> <p>Support decisions related to product safety, quality, and customer satisfaction using both data-driven and risk-based approaches.</p> <p>Participate in and support internal and external audits and regulatory inspections as required.</p> <p>Qualifications</p> <p>Education and Experience:</p> <p>Minimum of 4 years' experience in Quality Design Assurance within the medical device industry</p> <p>Bachelor's degree (BA/BS) in engineering, life sciences or related technical field</p> <p>Working knowledge of medical device quality management systems including 21 CFR Part 820 and ISO 13485; experience with AS9100 acceptable</p> <p>Demonstrated experience in design assurance activities, including design verification, test method validation and statistical analysis.</p> <p>Proficiency with standard office and quality/design engineering software tools</p> <p>Must be comfortable with a hands-on approach to product development testing.</p> <p>Excellent organizational and time management skills</p> <p>Experience working with electromechanical medical devices or systems is required.</p> <p>Experience with risk management and quality/regulatory requirements throughout the product development lifecycle.</p> <p>Required Skills/Abilities:</p> <p>Leadership:</p> <p>Serves as a technical leader in design assurance, guiding teams through the application of design controls, risk management, and verification/validation activities across the product development lifecycle.</p> <p>Leads or supports product development initiatives by identifying and resolving design-related quality issues, ensuring compliance with applicable regulatory requirements and internal procedures.</p> <p>Collaborates effectively on cross-functional teams to define and implement robust design assurance strategies that align with quality system requirements and support product safety and effectiveness.</p> <p>Communication:</p> <p>Excellent written and oral communication skills</p> <p>Ability to formulate responses to common inquiries from customers and regulatory agencies.</p> <p>Ability to review, analyze, summarize and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give presentations.</p> <p>Physical Requirements / Work Conditions:</p> <p>Percentage of travel 10%</p> <p>Prolonged periods of sitting at a desk and working on a computer.</p> <p>Must be able to lift up to 15 pounds at times.</p> <p>Office, Manufacturing floor</p> <p>Elucent Medical Benefits, Culture and Work Environment</p> <p>At Elucent Medical, we prioritize our employees' well-being by providing comprehensive benefits including comprehensive health insurance, a generous retirement savings plan with company matching, flexible work arrangements, generous paid time off, and ongoing professional development opportunities, ensuring a fulfilling and balanced work life.</p> <p>Fulltime Employees are provided:</p> <p>401(k)</p> <p>401(k) matching (4%)</p> <p>Dental insurance</p> <p>Health insurance</p> <p>Vision insurance</p> <p>Paid Holidays</p> <p>Paid Vacation Days</p> <p>Paid Sick Days</p> <p>Short Term Disability</p> <p>Long Term Disability</p> <p>Life Insurance</p> <p>Pet Insurance</p> <p>Employee Assistance Programs</p> <p>Affirmative Action / EEO Statement</p> <p>Elucent Medical 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.</p> <p>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.</p> <p>Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.</p>