Principal Design Engineer

Medline Industries, Inc.; Eagan (MN); On-site; USD 116,000 - 174,000; Full time

Job summary

Medline Industries, Inc. in Minnesota is seeking a Senior Product Design Engineer to manage multi-disciplinary product development teams and guide the design of new medical devices from concept through 510(k) submission and launch.

The role requires a Bachelor's degree in mechanical, biomedical, electrical, or software engineering; 7+ years in product design; Proficiency in SolidWorks; and experience with polymers, risk assessments, design controls, and FDA 510(k) processes in the medical device

Qualifications

• Bachelor's degree in mechanical, biomedical, electrical, or software engineering.
• 7+ years of product design experience; SolidWorks proficiency; prototype fabrication.
• Certified SolidWorks Professional preferred; 10+ years experience; medical device industry knowledge.

Responsibilities

• Lead multi-disciplinary product development teams to design and develop new products.
• Collaborate with customers, quality, regulatory, and manufacturers to ensure launches.
• Develop design specifications and manage multiple project timelines.
• Coordinate ideation through 510k and product launch.
• Review existing products and implement improvements from feedback.
• Support design transfer to manufacturing and validate designs with suppliers.
• Contribute to IP development and manage day-to-day team activities.

Skills

Product design

Project management

Cross-functional collaboration

Risk assessments

Education

Bachelor's degree in mechanical/biomedical/electrical/software engineering

Tools

SolidWorks

3D modeling software

Prototype fabrication

Microsoft Project

Job description

Job Summary

Responsible for managing product development teams as well as coordinating all aspects of the design and development of new products and technologies. Provide expertise on product design and optimize design specifications.

Lead product design assignments in product development initiatives.

Job Description

MAJOR RESPONSIBILITIES:

• Manage multi-disciplinary product development teams to research, design, and develop new products and technologies. Ensure that deadlines and product goals are met.
• Collaborate with customers, quality, regulatory, legal, manufacturers, and divisional personnel to ensure new product designs meet all product requirements and experience a successful launch.
• Develop design specifications, manage multiple project timelines, and balance corporate priorities for product development projects to ensure that deadlines and goals are met.
• Collaborate with product divisions to proactively identify product development opportunities, establish innovation pipelines, and align product development efforts with long-term divisional strategies.
• Coordinate and support all phases of product development from ideation to 510k application to product launch.
• Review existing products and recommend improvements based on existing complaints, risk analyses, manufacturer feedback, cost saving opportunities, etc.
• Support design transfer to manufacturing sites and new product implementation process. Collaborate with domestic and international manufacturers to validate designs and troubleshoot problems that arise.
• Coordinate product design and laboratory teams to ensure all design inputs are verified and validated.
• Contribute to new product designs, prototype generation/evaluation, and review technical drawings/specifications.
• Work with legal to design and implement new intellectual property.
• This is a high-level individual contributor role - management responsibilities limited to leading day-to-day activities and outcomes of a group of employees.
• May be involved in hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

MINIMUM JOB REQUIREMENTS:

Education:

• Bachelor's degree in mechanical engineering, biomedical engineering, electrical engineering, or software engineering

Certification / Licensure:

• None

Work Experience:

• At least 7 years of experience in product design.
• Experience with Solidworks/3D modeling software and prototype fabrication.

Knowledge / Skills / Abilities:

• None

PREFERRED JOB REQUIREMENTS:

Education:

• None

Certification / Licensure:

• Certified Solidworks Professional.

Work Experience:

• At least 10 years of experience in product design.
• Experience testing and development of polymers, textiles, medical equipment/devices, etc within in the medical device industry.
• Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.
• Experience designing and launching class II medical device to market.
• Experience with project management, Microsoft project, and leading multi-disciplinary teams.
• Invented and recognized on at least one patent.

Knowledge / Skills / Abilities:

• Position requires travel up to 10% of the time for business purposes (domestic and international).
• Knowledge of injection molding and other manufacturing processes.

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:

$116,000.00 - $174,000.00 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.

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.