"Alerted.org

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 II, III, Sr.

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

SALARY RANGE: $92,000 to $120,000

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.

ESSENTIAL FUNCTIONS:

Surgical Device Engineer I

+ Acting as Voice of Customer within the company.

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

+ Provide input to risk documentation, including dFMEAs, pFMEAs, and uFMEAs.

+ Participate in evaluation of prototype devices.

+ Create risk analysis and root cause analysis for product examination reports within the Complaint Handling System.

+ Participate in complaints review.

+ Participate in review of new or revised packaging for sterilization requirements.

+ NCMR input and approval.

Surgical Device Engineer II

+ All the knowledge, skills & abilities listed above.

+ Review and approve product drawings and participate in design reviews.

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

+ Revise uFMEA based on reported complaints.

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

+ Participate in IFU and labeling artwork development.

+ Report on complaint status to executive management.

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

Surgical Device Engineer III

+ All the knowledge, skills & abilities listed above.

+ 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.

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

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

+ Lead sterilization testing and cycle adoption for new products, and updates to existing products.

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

+ Monitor information from complaints to enable early awareness of device trends and identify opportunities of improvement.

Senior Surgical Device Engineer

+ All the knowledge, skills & abilities listed above.

+ Monitor information from various sources to enable early awareness of device trends and implement improvements.

+ Identification and evaluation of benchmark and compatible products.

+ Provide design input on new packaging for sterilization requirements.

+ Development and execution of statistically valid device usability evaluation protocols.

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

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 & III Surgical Device Engineers and other team members regarding best practices on SDE areas of expertise.

+ All other duties as assigned.

EDUCATION & EXPERIENCE:

Surgical Device Engineer I

+ Bachelor’s Degree or higher in Engineering or related technical discipline required.

+ 0-2 years of experience of engineering experience in medical device or other regulated industry preferred.

Surgical Device Engineer II

+ Bachelor’s Degree or higher in Engineering or related technical discipline required.

+ 2 or more years of experience of engineering experience in medical device or other regulated industry required.

Surgical Device Engineer 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 Surgical Device Engineer

+ Bachelor’s Degree in Engineering required, Master’s Degree preferred.

+ 9 or more years of engineering experience in medical device or other regulated industry required.

+ 7 or more years of Engineering experience in medical device or other regulated industry acceptable with Master’s Degree.

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

+ All the knowledge, skills & abilities listed above.

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

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

+ 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 preferred.

+ Ability to communicate with all levels of the organization.

+ Proficiency with written and verbal presentation to Senior Leadership.

Surgical Device Engineer III

+ All the knowledge, skills & abilities listed above.

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

+ Knowledge of regulatory requirements, including FDA and ISO standards required.

+ Familiarity with common manufacturing processes required.

+ Able to work independently with minimal supervision.

+ Expert proficiency with written and verbal presentation to Senior Leadership.

Senior Surgical Device Engineer

+ All the knowledge, skills & abilities listed 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.

+ Knowledge of anatomy and surgery required.

+ Familiarity with common manufacturing processes required.

+ Strong knowledge of regulatory requirements, including FDA and ISO standards.

+ Ability to communicate with medical professionals and surgeons required.

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.