Sr Engineer Design

Medline International Two Australia Pty; Northfield Township (IL); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Northfield, Illinois seeks a Senior Design Engineer to lead complex medical device design initiatives, translate user needs into specifications, and ensure regulatory compliance. You will mentor engineers and drive design excellence across the product lifecycle.

The role emphasizes design controls, risk management (FMEA), and collaboration with regulatory, clinical, and quality teams to support product launches and continuous improvement. Travel up to 10% is expected.

Qualifications

• Bachelor's degree in mechanical, biomedical, electrical engineering, or related field.
• Minimum of 4 years in product design within regulated environments (medical devices).
• Experience with design controls, risk management, and cross-functional collaboration.

Responsibilities

• Lead product design efforts with CAD models, prototypes, and documentation meeting design inputs and regulatory requirements.
• Utilize SolidWorks and CAD tools to produce 3D models, PCB layouts, and design documentation.
• Collaborate with product management, clinical, regulatory and quality teams to define user needs and translate into specifications.
• Drive design transfer activities from R&D to manufacturing with validation builds and process development.
• Mentor junior engineers and participate in design reviews to foster technical excellence.
• Incorporate human factors and user-centered design to enhance safety and usability.
• Lead multi-disciplinary teams to research and develop new products and technologies.
• Coordinate timelines, resources, and priorities to meet milestones and business objectives.
• Evaluate and improve existing products via root cause analysis, risk assessments, and post-market feedback.

Skills

Cross-functional collaboration

Regulatory awareness

Problem solving

Communication

Education

Bachelor's degree in mechanical engineering

Tools

SolidWorks

Job description

## Sr Engineer DesignApplyremote type: Hybridlocations: Northfield, Illinoistime type: Full timeposted on: Posted Todayjob requisition id: R2615018**Job Summary** Responsible for leading complex product design initiatives within cross-functional development teams. This role involves researching, designing, and prototyping innovative medical devices, translating user needs into design specifications, and ensuring compliance with regulatory standards. The Senior Design Engineer provides technical expertise, mentors junior engineers, and drives design excellence throughout the product development lifecycle, contributing to successful product launches and continuous improvement efforts.**Job Description**## Responsibilities:* Lead product design efforts by developing CAD models, prototypes, and technical documentation that meet design inputs and regulatory requirements.* Utilize engineering tools such as SolidWorks and other CAD software to produce 3D models, PCB layouts, and design documentation in accordance with internal standards and regulatory requirements.* Guide cross-functional collaboration with product management, clinical, regulatory, and quality teams to define user needs and translate them into actionable design specifications.* Drive design transfer activities, ensuring smooth transition from R&D to manufacturing through validation builds, process development, and troubleshooting.* Support intellectual property strategy by identifying novel design concepts and partnering with legal to secure patents.* Mentor junior engineers and contribute to design reviews, fostering a culture of technical excellence and continuous improvement.* Integrate human factors and user centered design philosophies into product development to enhance safety, effectiveness, and user satisfaction.* Lead multi-disciplinary product development teams to research, design, and develop new products and technologies. Ensure product designs meet all design specifications.* Manage multiple projects by coordinating timelines, resources, and priorities to meet development milestones and business objectives.* Evaluate and improve existing products through root cause analysis, risk assessments, and feedback from users, manufacturers, and post-market surveillance.* Contribute to innovation pipelines by collaborating with product divisions to identify new product opportunities, and align product design efforts with long-term strategic goals.## ## Qualifications:**Education*** Bachelor's degree in mechanical engineering, biomedical engineering, electrical engineering, or related technical field.**Work Experience*** Minimum of 4 years of experience in product design, preferably within a regulated industry such as medical devices. Advanced proficiency in SolidWorks or equivalent 3D CAD software, including experience with prototype development, design documentation, and design for manufacturability.* Demonstrated experience working within a structured product development process, including exposure to design controls, risk management, and cross-functional collaboration.## Preferred Qualifications:**Certification / Licensure*** Certified Solidworks Professional certification.**Work Experience*** Experience in product design within the medical device industry, including development and launch of Class II devices.* Strong understanding of design controls, risk management (e.g., FMEA), and regulatory documentation (e.g., DHF, DMR, traceability matrices).* Experience designing and launching class II medical device to market, including managing develpment timelines and milestones.* Recognized contributor to intellectual property**Knowledge / Skills / Abilities*** Position requires travel up to 10% of the time for business purposes (domestic and international).* Strong working knowledge of manufacturing processes such as injection molding, machining, and assembly techniques relevant to medical devices.* Strong analytical and problem-solving skills, with the ability to troubleshoot complex design and manufacturing issues.* Familiarity with regulatory standards including FDA 21 CFR Part 820, ISO 13485, and ISO 14971.* Effective communication and collaboration skills, with experience working in cross-functional teams.Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.The anticipated salary range for this position:$101,000.00 - $152,000.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.### Why work here?Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time. If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you.### Introduce YourselfIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.### About UsMedline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. To learn more about how Medline makes healthcare run better, visit www.medline.com.