Senior Mechanical Design Engineer

Ontogen Medtech; Lisle (IL); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance

401k company contribution

Quarterly bonus program

Unlimited PTO

Job summary

Ontogen Medtech in Lisle, IL, is seeking a Senior Mechanical Design Engineer to aid in developing innovative medical device products. The ideal candidate will have a solid background in medical device design with extensive experience in SolidWorks.

This role includes responsibilities like product design, prototype testing, and regulatory support. The compensation includes a salary range of $100k-$130k plus bonuses and benefits.

Qualifications

• 5+ years of Medical Device R&D experience.
• Demonstrated mastery of SolidWorks including surfaces and parametric modeling.
• Excellent communication skills, especially in technical writing.

Responsibilities

• Product conceptualization and design.
• Creation and review of SolidWorks CAD models.
• Conducting prototype tests and gathering test data.

Skills

SolidWorks

Product Development

Medical Device Design

Technical Writing

Critical Thinking

Education

BS in Mechanical Engineering

MS in Mechanical Engineering

Tools

CAD Models

Job description

Ontogen Medtech seeks a Senior Mechanical Design Engineer to join its product development team to assist with activities related to the development of innovative medical device products in Chicagoland, IL. We are seeking someone with extensive experience in medical device design, development, and manufacturing who is comfortable leading product development projects. This position requires a creative mind and an ability to transform abstract concepts and design challenges into viable product designs.

Responsibilities may include:

• Product conceptualization/ideation and design
• Creation and review of SolidWorks CAD models/assemblies and 2D drawings
• Design for Manufacturability and Assembly
• Proof of concept hands-on prototype fabrication
• Design troubleshooting and root cause analysis
• Design and creation of new test methods and fixtures
• Tolerance Stackup Analysis
• DHF documentation preparation
• Drafting and executing test protocols
• Conducting prototype tests
• Gathering, organizing, and reporting test data
• Regulatory submission preparation support
• Documenting official procedures
• Frequent interaction with vendors and suppliers to ensure timely completion of deliverables

At minimum, candidates will have:

• BS in Mechanical Engineering, or equivalent
• 5+ years Medical Device R&D experience
• Demonstrated mastery of SolidWorks, including surfaces, parametric modeling, etc.
• Demonstrated expertise generating product ideas and developing through to production
• Experience with medical device development and FDA quality practices and standards, including ISO 13485;
• Demonstrated understanding and experience with common medical device packaging materials and techniques, sterilization processes and techniques, sterilization validation, etc.
• Demonstrated ability to work independently with minimal supervision
• Excellent oral and written communication skills, particularly in technical writing and documentation
• Demonstrated organizational, interpersonal, and critical thinking skills.

Additionally, the following are highly desirable:

• MS in Mechanical Engineering, or equivalent
• Prior experience working in a fast-paced medtech startup environment

Compensation: base salary range $100k-$130k + bonus, commensurate with experience.

Ontogen Medtech offers benefits including medical insurance, 401k company contribution, quarterly bonus program, unlimited PTO, etc.

Ontogen Medtech is an equal opportunity employer. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the U.S. and to complete the required verification document upon hire.