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Ontogen Medtech · 1 month ago

Sr Mechanical Design Engineer

Lisle, IL

Full-time

Onsite

Mid, Senior Level

$100K/yr - $130K/yr

6+ years exp

Ontogen Medtech is seeking a Senior Mechanical Design Engineer to join its product development team. The role involves leading product development projects and transforming design challenges into viable medical device products.

Medical DeviceProduct DesignQuality Assurance

Responsibilities

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

Qualification

Medical Device R&DSolidWorksPlastics DesignFDA Quality PracticesTechnical WritingInterpersonal SkillsCritical ThinkingOrganizational Skills

Required

BS in Mechanical Engineering, or equivalent

6+ 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

Strong expertise in plastics design for injection molding

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