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# Sr Engineer Design

- **Company:** Medline Industries, Inc
- **Location:** Northfield, IL, United States
- **Experience:** Expert
- **Salary:** $101,000.0 - $152,000.0
- **Contract:** Permanent contract
- **Skills:** 3d Models, Computer-Aided Design, SolidWorks (CAD), Failure Mode Effects Analysis, Software Tools, User-Centered Design, 21 CFR Part 820 Quality System Regulation, Pcb Layout
- **Published:** October 17, 2026
- **Apply:** https://www.careerjet.com/job/usd2c35a2ea1acbee613d85add81a8dd90/eaa

## About the Role

* 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.

## Description

* 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.