Surgical Device Engineer I, II, Sr

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: Surgical Device Engineer I, II, Sr

SHIFT HOURS: 8:00am to 5:00pm

LOCATION: Onsite at LSI Solutions in
Victor, NY

SALARY PAY RANGE: $90,000.00 - $115,000.00

SURGICAL DEVICE ENGINEER JOB SUMMARY: Provide application focused insight to the assigned product line and advocate for the benefit of the customer in internal forums, contributing to both new product development as well as ongoing improvement activities that support existing product. This role is structured to prioritize influence on one of two topic areas but is able to contribute to the alternate topics when necessary.

SURGICAL DEVICE ENGINEER ESSENTIAL FUNCTIONS:

Acting as Voice of Customer within the company.

Level I: Participate in Usability Engineering process for new product including uFMEA, Formative testing, and Summative Usability testing.

Level II & Senior: Direct Usability Engineering process of new product within the assigned product line, including Use Specification, uFMEA, implementation of necessary changes post Formative Usability testing, and contributing to Summative Usability testing.

Provide input to risk documentation.

Review and approve product drawings and participate in design reviews.

Participate in bench-top, animal, and cadaver laboratories and studies as necessary.

Observe surgical procedures to better understand device performance in the field.

Product Definition Focus:

Creation of Design Inputs for new product development in the form of device requirements and specifications.

Identification and evaluation of benchmark and compatible products.

Consistency and clarity of labeling content, including Product Inserts and packaging labels.

Participate in evaluation of prototype devices.

Review and approve product drawings and participate in design reviews.

Provide input on new packaging.

Product Refinement Focus:

Creation of accurate simulated-use tests to assess overall product performance to ensure Design Outputs continue to meet expectations under various use environments.

Development and execution of statistically valid device evaluation protocols.

Review product examination reports within the Complaint Handling System.

Monitor information from various sources to enable early awareness of device trends and identify opportunities of improvement.

Communication of post-market surveillance and trend analysis pertinent to the assigned product line.

Review and provide input to design verification and validation (V&V) protocols and reports.

ADDITIONAL RESPONSIBILITIES:

Participate in review & disposition of Non-Conforming Material Reports.

Participate in Corrective and Preventive Action (CAPA) teams.

Serve as a member of the Clinical Liaison Team.

Senior level mentor level I & II Surgical Device Engineers and other team members regarding best practices on SDE areas of expertise.

All other duties as assigned.

SURGICAL DEVICE ENGINEER EDUCATION & EXPERIENCE:

Surgical Device Engineer I

Bachelor's Degree in Engineering required.

1-4 years of experience in manufacturing or engineering required.

Experience in the Medical Device Industry preferred.

Surgical Device Engineer II

Bachelor's Degree in Engineering required.

5-8 years of experience in manufacturing or engineering required.

Experience in the Medical Device Industry required.

Senior Surgical Device Engineer

Bachelor's Degree in Engineering required, Master's Degree preferred.

9+years of experience in manufacturing or engineering required.

Minimum 3 years of experience in the medical device industry required.

SURGICAL DEVICE ENGINEER KNOWLEDGE, SKILLS & ABILITIES:

Surgical Device Engineer I

Knowledge of applicable standards related to medical device manufacturing preferred, including:

ISO 62366-1 (Usability Engineering for Medical Devices)

ISO 13485 (Medical devices - Quality management systems)

21CFR820, 21CFR801

ISO 14971 (Risk Analysis)

Knowledge of risk management and analysis preferred.

Knowledge of mechanical engineering principles, including basic CAD proficiency preferred.

Proficiency with electronic change control systems (e.g. Product Data Management, Engineering Change Notice) preferred.

Familiarity with basics of surgery and anatomy preferred.

Familiarity with common manufacturing processes preferred.

Surgical Device Engineer II

Knowledge and successful application of applicable standards identified in SDE Level I above.

Knowledge of risk management and analysis (e.g., FMEA) required.

Knowledge of mechanical engineering principles, including basic CAD proficiency required.

Proficiency with electronic change control systems (e.g. Product Data Management, Engineering Change Notice) required.

Familiarity with basics of surgery and anatomy required.

Familiarity with common manufacturing processes required.

Ability to communicate with all levels of the organization including but not limited to medical professionals and surgeons required.

Senior Surgical Device Engineer

Knowledge and successful application of applicable standards identified in SDE Level I above.

Knowledge of risk management and analysis (e.g., FMEA) required.

Knowledge of mechanical engineering principles, including basic CAD proficiency required.

Proficiency with electronic change control systems (e.g. Product Data Management, Engineering Change Notice) required.

Familiarity with basics of surgery required.

Familiarity with common manufacturing processes required.

Ability to communicate with all level of the organization including but not limited to medical professionals and surgeons required.

SURGICAL DEVICE ENGINEER 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 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.