Sr Engineer Design

Medline Industries, LP; Northfield Township (IL); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Continuing education

Job summary

Medline Industries, LP in the United States is seeking a Senior Design Engineer to lead complex medical device design initiatives across cross-functional teams. You will research, design, prototype, and translate user needs into specifications while ensuring regulatory compliance.

You will mentor junior engineers, drive design excellence, and support DHF/DMR and risk management processes throughout the product lifecycle.

Qualifications

• Bachelor’s degree in a engineering field and 4+ years in regulated device design.
• Experience with design controls, risk management, and regulatory documentation.
• Certified SolidWorks Professional is preferred.

Responsibilities

• Lead product design by creating CAD models, prototypes, and design docs.
• Collaborate with product, clinical, regulatory, and quality teams to define user needs.
• Drive design transfer from R&D to manufacturing with validation builds.
• Support IP strategy by identifying concepts and coordinating with legal for patents.
• Mentor junior engineers and participate in design reviews.

Skills

Regulatory knowledge

Problem-solving

Cross-functional collaboration

Mentoring juniors

Design transfer

Education

Bachelor’s degree in mechanical engineering, biomedical engineering, electrical engineering, or related technical field

Tools

SolidWorks

Job description

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 Annual

The 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.

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 https://urldefense.com/v3/ https:/digital.alight.com/medline ;!!DjNdo6avjEs!o-bxZ6fy_WNH13q2FLYYmUMb1U4cic3ioox3ulm5dkpyivWM09cd64RN8rHuDH5AQKNiwEzHU2VbVJht5ginULSy5aJGsA$.

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.