Mechanical Engineer - Design III, Sr.

LSI Solutions Inc•Victor, NY

2d•$80,000 - $120,000•Onsite

About The Position

LSI SOLUTIONS® is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive surgical instruments through research, development, manufacturing, and marketing. We are searching for passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS® an ISO 13485 certified company, you will become part of as energetic team working together to relentlessly pursue better patient outcomes with state-of-the-art devices. As a Mechanical Engineer - Design, you will help bring a future generation of LSI products to market. You will be part of a team to further improve our current products that are already available by iterating on the innovative design. Working in a cross functional team, you will take ownership of all things related to the form, fit, function, and feel of the product. Other tasks include, stack up analysis, failure analysis, improvements for manufacturability, communicating design intent and inspection requirements with 3D and 2D CAD, and other tasks.

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.
3-5 or more years of Engineering experience in medical device or other regulated industry acceptable with Master’s Degree.
7-12 or more years of Engineering experience in medical device or other regulated industry required.
5-7 or more years of Engineering experience in medical device or other regulated industry acceptable with Master’s Degree.
12+ years of Engineering experience in medical device or other regulated industry required.
10 + years of Engineering experience in medical device or other regulated industry acceptable with Master’s Degree.
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.
Expert proficiency in Autodesk Inventor or other 3D CAD system required.
Expert proficiency in interpreting engineering drawings and schematics.
Proficiency in root cause analysis required.
Proficiency with Tolerance Analysis (stack-ups) required.
Proficiency with Minitab and statistical analysis required.
Able to work independently with minimal supervision.
Excellent time management skills.
Expert proficiency in standard MS-Office (MS Word, PowerPoint, and Excel) required.
Demonstration of leadership capability required.
Proficiency with Finite Element Analysis.
Proficiency with Robust Design analysis.
Strong knowledge of regulatory requirements, including FDA and ISO standards.
Proficiency with GD&T, Design for Manufacturing, Design for Reliability, Experimental Design (DOE).
Excellent communication and project management skills.
Ability to work independently and lead cross-functional teams.
Frequently required to lift, carry, push and/or pull from10-50 lbs.
Ability to periodically bend or kneel and use color vision/depth perception.
Sitting, standing and/or walking for up to eight hours per day.
Routine use of standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Regularly required to talk and/or hear.

Nice To Haves

0-2 years of Engineering experience in medical device or other regulated industry preferred.
2-5 or more years of Engineering experience in medical device or other regulated industry required.
Basic Proficiency in MS-Project preferred.
Familiarity with AutoCAD preferred.
Basic understanding of machining and fabricating technologies.
Familiarity with GD&T, Design for Manufacturing, Design for Reliability, Experiment Design (DOE).
Proficiency with written and verbal presentation of technical concepts to Senior Leadership.
Familiarity with Design Failure Mode Effects and Analysis preferred.
Familiarity with Minitab and statistical analysis preferred.
High attention to detail.
Expert proficiency in interpreting engineering drawings and schematics.
Strong understanding of machining and fabricating technologies.
Proficiency in FEA and other analytical methods preferred.
Proficiency with Design Failure Mode Effects and Analysis preferred.

Responsibilities

Support the development of component and surgical device designs, which meet product design requirements, specifications and customer usage requirements, focusing efforts on component level issues.
Support, create maintain design records and product family history.
Use CAD software, such as AutoCAD and Inventor, to prepare technical drawings and models.
Understand and identify high risk product features and functions which impact the customer.
Support product design reviews, effectively communicate design changes and associated impacts.
Identify and reduce design risks through deployment of analytical design methods.
Lead development of components and surgical device designs, which meet product design requirements, specifications and customer usage requirements, focusing efforts on component interactions and assembly level issues, delegating component level issues to junior team members.
Lead product design reviews, effectively communicate design changes and associated impacts.
Responsible for creating and updating Design FMEAs to develop robust designs.
Responsible for using the output from FMEAs to determine qualification requirements and pass/fail criteria for in-process testing.
Lead development of advanced components and surgical device designs, which meet product design requirements, specifications, and customer usage requirements, focusing efforts on component interactions and assembly level issues, delegating component level issues to junior team members.
Responsible for complex and robust designs.
Lead development of complex components and surgical device designs, which meet product design requirements, specifications, and customer usage requirements, focusing efforts on component interactions and assembly level issues, delegating component level issues to junior team.
Provide leadership to the Product Engineering function for major and high-volume projects, guiding week to week priorities based on project needs.
Provide functional expertise and mentorship to the Product Engineering function.
Subject matter expert on product group.
Understands all product features and functions and owns the design at all stages of the product lifecycle.
Provide technical guidance and mentorship to junior engineers.
Stay current on emerging technologies and industry trends to improve the performance and safety of medical devices.
Support development of Design Requirements and Specifications.
Support Testing and Validation function, through participation in specification development test planning, design reviews based on build and test results, 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 as required.
All other duties as assigned.