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Senior Design Engineer
4 weeks ago
Senior R&D Design Engineer Location: Eagan, MN 55121 Duration: Direct Hire Compensation: Up to $140,000 Required Skills & Experience - Bachelor’s degree in Engineering or related field. - 5+ years of engineering experience, preferably in medical device design. - Experience writing technical documentation and developing finished goods specifications. - Proficiency in CAD (SolidWorks preferred) and design tools such as FEA, DFSS, DFM, ISO/CE Mark, GMP, GDP, ASME Y14.5, and GD&T. Nice to Have Skills & Experience - Degree in Mechanical or Biomedical Engineering. - 3+ years in the medical device industry, especially Class I disposable devices. - Knowledge of plastic film processing, pressure-sensitive adhesives, and medical-grade materials. - Familiarity with regulatory standards (ISO 13485, ISO 14971, IEC 60601). - Strong communication, organizational skills, and attention to detail. - Experience in customer-facing roles. Job Description We are seeking a Senior Design Engineer to join a medical device manufacturing company's Research, Development & Engineering (RD&E) team. This is a high-impact role for a creative, high-energy engineer who thrives on innovation and autonomy. As the sole Sr. Design Engineer onsite in Minnesota, you’ll lead the charge in developing sterile medical technologies that blur the lines between product and process. You’ll collaborate cross-functionally with teams in Georgia, the Dominican Republic, and across Medline to bring cutting-edge solutions to market. This is a unique opportunity to shape your career in a growth-focused organization that values continuous improvement, diverse perspectives, and intellectual property development. Key Responsibilities: - Serve as the technical lead for new product initiatives in sterile barrier protection. - Design innovative medical devices (non-Class III), create and evaluate prototypes, and produce detailed technical drawings and specifications. - Translate user needs into actionable design requirements in collaboration with business teams. - Work cross-functionally with Supply Chain, Manufacturing, Quality, and Regulatory to ensure designs are feasible, compliant, and manufacturable. Evaluate usability, performance, and manufacturability of prototypes and final designs. - Use CAD software (preferably SolidWorks) to create models, drawings, and layouts. - Ensure compliance with medical device regulations and quality systems (ISO, GMP, GLP). - Partner with Legal and IP teams to identify and support patent opportunities. - Drive innovation by integrating product and process design strategies.