Job Information
LSI Solutions Mechanical Engineer - Validation I, II, III, Sr. in Victor, New York
LSI SOLUTIONS® founded in 1986, located in beautiful Victor, New York, 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 have doubled in size in just the last 4 years! The LSI Campus includes 10 buildings (170,000+ sq ft) on 95 meticulously cared for acres.
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. After all, our customer is ultimately the patient.
POSITION TITLE: Mechanical Engineer - Validation I, II, III, Sr.
LOCATION: Onsite at LSI Solutions in Victor, NY
WORK HOURS: 8:00AM - 5:00PM
SALARY RANGE: $77,000.00 - $111,000.00
JOB SUMMARY: The Mechanical Engineer - Validation (DVE) is responsible for designing and conducting testing to verify and validate that LSI’s products are safe, reliable, and effective. The DVE supports the introduction of new products as well as the continued improvement of existing products. This is accomplished through the quantification and mitigation of design risk as well as measuring and improving design reliability. Working on a cross-functional team throughout the entire development process, DVE’s prove LSI’s products’ performance meets the needs of the surgeons and patients.
ESSENTIAL FUNCTIONS:
Mechanical Engineer - Validation I
Execute exploratory and design confirmation test plans; which are part of the pro-active assessment and mitigation of risk through physical testing prior to V&V.
Support the development of measurement methods, functional tests, and customer usage test methods.
Ensure documentation of test methods in Work Instructions.
Support the execution of Product Design Verification and Validation plans.
Write design validation protocols and reports.
Support Design Reviews based on test results, communicate test results to a cross functional team ensuring maximum learning is incorporated into each design iteration.
Support device product problem resolution and diagnosis, root cause analysis and documentation through failure mode tracking.
Support the application of appropriate statistical methods to assess product performance.
Mechanical Engineer - Validation II
All essential functions listed above.
Execute Product Design Verification and Validation plans.
Lead Design Reviews based on test results, communicate test results to a cross functional team ensuring maximum learning is incorporated into each design iteration.
Lead device product problem resolution and diagnosis, root cause analysis and documentation through failure mode tracking.
Support in the application of appropriate statistical methods to assess product performance.
Document development activities in test reports.
Develop test protocols and test methods for new and existing products.
Mechanical Engineer - Validation III
All essential functions listed above.
Lead and direct the execution of Product Design Verification and Validation plans.
Lead the application of appropriate statistical methods to assess product performance.
Senior Mechanical Engineer - Validation
All essential functions listed above.
Provide functional expertise, leadership and mentorship to the Design Validation function.
Understand and communicate regulatory implications related to the Design Validation function.
Advanced knowledge of and experience in applying engineering principles, analytical techniques and judgement to independently resolve major technical issues.
ADDITIONAL RESPONSIBILITIES:
Support pro-active quantification and mitigation of design risk through the DFMEA process.
Support development of specifications through testing.
Support deployment of product testing methods to the Manufacturing and Operations functions.
All other duties as assigned.
EDUCATION & EXPERIENCE:
Mechanical Engineer - Validation I
Bachelor’s Degree or higher in Engineering or related technical discipline required.
0-2 years of Engineering experience in medical device or other regulated industry preferred.
Mechanical Engineer - Validation II
Bachelor’s Degree or higher in Engineering or related technical discipline required.
2 or more years of Engineering experience in medical device or other regulated industry required.
Mechanical Engineer - Validation III
Bachelor’s Degree or higher in Engineering or related technical discipline required.
5 or more years of Engineering experience in medical device or other regulated industry required.
3 or more years of Engineering experience in medical device or other regulated industry acceptable with Master’s Degree.
Senior Mechanical Engineer - Validation
Bachelor’s Degree or higher in Engineering or related technical discipline required.
7 or more years of Engineering experience in medical device or other regulated industry required.
5 or more years of Engineering experience in medical device or other regulated industry acceptable with Master’s Degree.
KNOWLEDGE, SKILLS & ABILITIES:
Mechanical Engineer - Validation I
Standard MS-Office Tools: WORD, EXCEL, POWERPOINT (Intermediate Proficiency).
Autodesk Inventor or other 3D CAD system (Basic Proficiency).
Minitab, Weibull++, or equivalent statistical software (Basic Proficiency).
Capable of written and verbal presentation of technical concepts to leadership (Intermediate Proficiency).
Mechanical Engineer - Validation II
All the knowledge, skills & abilities listed above.
Design Optimization and Experiment Design (DOE) Techniques (Basic Proficiency).
Design for Reliability, Reliability Engineering, and Sample Size Statistics (Basic Proficiency).
Minitab, Weibull++, or equivalent statistical software (Intermediate Proficiency).
Design Failure Mode Effects Analysis (Intermediate Proficiency).
Root Cause Analysis (Intermediate Proficiency).
Measurement System Evaluation and Analysis (Basic Proficiency).
Regulatory compliance related to the Design Validation function.
Mechanical Engineer - Validation III
All the knowledge, skills & abilities for Level II.
Design Optimization and Experiment Design (DOE) Techniques (Intermediate Proficiency).
Design for Reliability, Reliability Engineering, and Sample Size Statistics (Intermediate Proficiency).
Minitab, Weibull++, or equivalent statistical software (Intermediate Proficiency).
Design Failure Mode Effects Analysis (Intermediate Proficiency).
Root Cause Analysis (Intermediate Proficiency).
Measurement System Evaluation and Analysis (Intermediate Proficiency).
Senior Mechanical Engineer - Validation
All the knowledge, skills & abilities for Level III.
Minitab, Weibull++, or equivalent statistical software (Advanced Proficiency).
Root Cause Analysis (Advanced Proficiency).
PHYSICAL DEMANDS AND WORK ENVIRONMENT:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Frequently required to lift, carry, push and/or pull from 10-20 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.
LSI SOLUTIONS BENEFITS INCLUDE:
Bonus Plan, 401(k) plan with company match, Tuition Assistance, Employee Assistance Program (EAP) and Product Discounts
15 Paid Holidays, PTO, Sick Time
Medical, Vision and Dental effective first day of employment
LSI SOLUTIONS® is an equal opportunity employer and does not discriminate based on any legally protected status or characteristic.
Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.