Senior Design Engineer

Medline • Northfield, MN

4d

About The Position

The Senior Design Engineer manages product development teams and coordinates all aspects of designing and developing new products and technologies. The role provides product-design expertise, optimizes design specifications, and leads design assignments within product development initiatives. This is a high-level individual contributor position, with management responsibilities limited to leading the day-to-day activities and outcomes of a group of employees.

The engineer coordinates product development from ideation through 510(k) application and product launch, working across product divisions and with customers, quality, regulatory, legal, manufacturers, and other personnel. The position also supports design transfer and implementation, design verification and validation, prototype development, technical drawing review, product improvement, and the development and implementation of intellectual property. Travel of up to 10% for business purposes, both domestic and international, is required.

Requirements

• Bachelor's degree in mechanical engineering, biomedical engineering, electrical engineering, or software engineering.
• At least 7 years of experience in product design.
• Experience with SolidWorks or other 3D modeling software and prototype fabrication.

Nice To Haves

• Certified SolidWorks Professional.
• At least 10 years of experience in product design.
• Experience testing and developing polymers, textiles, medical equipment, or devices within the medical device industry.
• Experience with Class I–II medical device requirements, design controls, risk assessments, and the 510(k) process.
• Experience designing and launching a Class II medical device to market.
• Experience with project management, Microsoft Project, and leading multidisciplinary teams.
• Invention and recognition on at least one patent.
• Knowledge of injection molding and other manufacturing processes.

Responsibilities

• Manage multidisciplinary product development teams researching, designing, and developing products and technologies, ensuring deadlines and product goals are met.
• Collaborate with customers, quality, regulatory, legal, manufacturers, and divisional personnel so designs meet requirements and launch successfully.
• Develop design specifications, manage multiple project timelines, and balance corporate priorities for product development projects.
• Identify product development opportunities with product divisions, establish innovation pipelines, and align development with long-term divisional strategies.
• Coordinate and support product development from ideation through 510(k) application and product launch.
• Review existing products and recommend improvements based on complaints, risk analyses, manufacturer feedback, and cost-saving opportunities.
• Support design transfer to manufacturing sites and new product implementation; work with domestic and international manufacturers to validate designs and troubleshoot problems.
• Coordinate product design and laboratory teams to ensure design inputs are verified and validated.
• Contribute to product designs and prototype generation and evaluation, and review technical drawings and specifications.
• Work with legal to design and implement new intellectual property.
• Lead day-to-day activities and outcomes of a group of employees; may participate in hiring, recommending pay increases, performance reviews, staff training and development, personnel planning, work assignment, completion-date management, and consistent policy application.
• Travel up to 10% of the time for domestic and international business purposes.

Benefits

• Competitive total rewards package.
• Continuing education and training.
• Health insurance for eligible employees.
• Life and disability insurance for eligible employees.
• 401(k) contributions.
• Paid time off.
• Bonus and/or incentive eligibility.
• For employees working under 30 hours per week on average: access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior