Mechanical Engineer - Design III or Sr.

LSI Solutions Inc•Victor, NY

5d•Onsite

About The Position

LSI SOLUTIONS® is a growing medical device company seeking passionate individuals to advance minimally invasive surgical instruments. As a Mechanical Engineer - Design, you will contribute to bringing new products to market and improving existing ones. You will work within a cross-functional team, taking ownership of product form, fit, function, and feel. Responsibilities include stack-up analysis, failure analysis, improving manufacturability, and communicating design intent and inspection requirements using CAD.

Requirements

Bachelor’s Degree or higher in Engineering or related technical discipline or equivalent industry experience required.
5-7 or more years of Engineering experience in medical device or other regulated industry required (for Design III).
7-12 or more years of Engineering experience in medical device or other regulated industry required (for Senior).
Basic proficiency in standard MS-Office (MS Word, PowerPoint, and Excel) required.
Proficiency in Autodesk Inventor or other 3D CAD system required.
Proficiency in interpreting engineering drawings and schematics.
Familiarity with Tolerance Analysis required.
Intermediate proficiency in standard MS-Office (MS Word, PowerPoint, and Excel) required (for Design II, III).
Expert proficiency in Autodesk Inventor or other 3D CAD system required (for Design II, III).
Expert proficiency in interpreting engineering drawings and schematics (for Design II, III).
Strong understanding of machining and fabricating technologies (for Design II, III).
Proficiency with root cause analysis required (for Design II, III).
Proficiency with Tolerance Analysis (stack-ups) required (for Design II, III).
Proficiency with Minitab and statistical analysis required (for Design II, III).
Able to work independently with minimal supervision (for Design II, III).
Excellent time management skills (for Design II, III).
Expert proficiency in standard MS-Office (MS Word, PowerPoint, and Excel) required (for Senior, Principal).
Demonstration of leadership capability required (for Senior, Principal).
Proficiency with Finite Element Analysis (for Senior, Principal).
Proficiency with Robust Design analysis (for Senior, Principal).
Strong knowledge of regulatory requirements, including FDA and ISO standards (for Senior, Principal).
Proficiency with GD&T, Design for Manufacturing, Design for Reliability, Experimental Design (DOE) (for Senior, Principal).
Excellent communication and project management skills (for Senior, Principal).
Ability to work independently and lead cross-functional teams (for Senior, Principal).

Nice To Haves

0-2 years of Engineering experience in medical device or other regulated industry preferred (for Design I).
Basic Proficiency in MS-Project preferred (for Design I).
Familiarity with AutoCAD preferred (for Design I).
Familiarity with GD&T, Design for Manufacturing, Design for Reliability, Experiment Design (DOE) (for Design I).
Familiarity with Design Failure Mode Effects and Analysis preferred (for Design I).
Familiarity with Minitab and statistical analysis preferred (for Design I).
Proficiency in FEA and other analytical methods preferred (for Design II, III).
Proficiency with Design Failure Mode Effects and Analysis preferred (for Design II, III).
3-5 or more years of Engineering experience in medical device or other regulated industry acceptable with Master’s Degree (for Design III).
5-7 or more years of Engineering experience in medical device or other regulated industry acceptable with Master’s Degree (for Senior).
10 or more years of Engineering experience in medical device or other regulated industry acceptable with Master’s Degree (for Principal).

Responsibilities

Support the development of component and surgical device designs that meet product design requirements, specifications, and customer usage requirements.
Support, create, and maintain design records and product family history.
Use CAD software (e.g., AutoCAD, Inventor) to prepare technical drawings and models.
Understand and identify high-risk product features and functions impacting the customer.
Support product design reviews and effectively communicate design changes and their impacts.
Identify and reduce design risks through analytical design methods.
Lead development of components and surgical device designs, focusing on component interactions and assembly level issues.
Lead product design reviews, effectively communicating design changes and associated impacts.
Create and update Design FMEAs to develop robust designs.
Use FMEA outputs to determine qualification requirements and pass/fail criteria for in-process testing.
Lead development of advanced components and surgical device designs.
Responsible for complex and robust designs.
Provide leadership to the Product Engineering function for major and high-volume projects, guiding week-to-week priorities.
Provide functional expertise and mentorship to the Product Engineering function.
Serve as a subject matter expert on product groups.
Understand all product features and functions and own the design throughout the product lifecycle.
Provide technical guidance and mentorship to junior engineers.
Stay current on emerging technologies and industry trends to improve medical device performance and safety.
Support development of Design Requirements and Specifications.
Support the Testing and Validation function through participation in specification development, test planning, design reviews, product development and validation planning, test method development, and measurement system analysis.
Support Manufacturing and Operations functions in identifying key process characteristics, suggesting process and inspection methods, and assisting with process fixtures, testing, and equipment qualifications.
Perform all other duties as assigned.