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. JOB TITLE : Design Quality Engineer I, II or Sr. (Days) SALARY RANGE: $74,000.00 - $110,000.00 POSITION HOURS: 8:00AM - 5:00PM LOCATION: Onsite at LSI Solutions in Victor, NY DESIGN QUALITY ENGINEER JOB SUMMARY: Perform quality engineering tasks for new & existing product and process development and improvement initiatives. Quality Engineers are specialized in either Supplier Quality Engineering, Design Quality Engineering, Metrology Quality Engineering or Finished Goods Quality Engineering. Quality Engineers interface with other functions within an organization and with internal and external customers and suppliers on quality-related issues. DESIGN QUALITY ENGINEER ESSENTIAL FUNCTIONS: Level I:
Assist in the development of Quality Management System (QMS) processes and procedures to ensure compliance with applicable regulations.
Coordinate and disposition non-conforming product.
Perform data analysis, and develop, monitor, and oversee metrics reporting.
Lead and/or support continuous improvement activities.
Support and participate in internal and external audits and inspections.
Generate and maintain procedures, work instructions, inspection plans, forms, and templates.
Lead and/or participate on Corrective Action and Preventive Action (CAPA) investigations.
Review/approve verification & validation protocols and reports.
Level II:
Demonstrate knowledge in the Quality Engineering functions listed above, plus:
Lead Activities for the development of the QMS.
Responsibility and ownership for product line and/or process Quality Engineering deliverables.
Lead continuous improvement activities.
Lead Corrective Action and Preventive Action (CAPA) investigations.
Work independently as a self-starter with minimal direction.
Senior:
Demonstrate advanced knowledge in the Quality Engineering functions listed above, plus:
Act as a team lead for Quality Engineers or subject matter expert in a critical field of the Quality Management System (QMS).
Identify areas for improvement within the QMS and lead/implement activities for improvement.
Able to teach and mentor Quality Engineers in the use of key Quality concepts.
DESIGN QUALITY ENGINEER DIFFERENTIATING ESSENTIAL FUNCTIONS:
Quality Engineers each report through a particular focus of the Quality Management System. While most of the essential functions are universal, the following responsibilities are driven by this difference in reporting structure.
Generate and maintain risk documentation, including, but not limited to Hazard Assessments, Risk Assessments, and Risk Reports, and be a strong contributing team member to Failure Mode and Effects Analyses (FMEA’s).
Create statistically rationalized component and product acceptance inspection plans.
Analyze data using tools such as Capability Analyses/Studies, SPC, and trend analyses to update inspection plans and control plans.
Apply Design Controls Management knowledge to product design and gate reviews, as well as Design History File (DHF) updates, by reviewing and approving technical documentation such as project charters, drawings, and validation/verification protocols, reports, and records.
Review and approve New Product Development project deliverables, as well as product enhancement project deliverables, for compliance, completeness, and consistency, with a focus on “Design for Quality.”
DESIGN QUALITY ENGINEER ADDITIONAL RESPONSIBLITIES:
All other duties as assigned.
DESIGN QUALITY ENGINEER EDUCATION & EXPERIENCE:
Level I:
Bachelor’s degree or higher in a technical discipline required.
0-3 years of relevant Engineering experience in medical device or other regulated industry preferred.
Level II:
Bachelor’s degree or higher in a technical discipline with 3 or more years of relevant experience in medical device or other regulated industry required.
Senior:
Bachelor’s degree or higher in a technical discipline with 7 or more years of relevant Quality experience in medical device or other regulated industry required.
Master’s degree in a technical discipline with 5 or more years as a Quality Engineer.
DESIGN QUALITY ENGINEER KNOWLEDGE, SKILLS & ABILITIES:
The following KSAs apply to all Quality Engineers:
Knowledge and application of ISO 13485.
Strong problem solving, root cause analysis and analytics skills.
Familiarity with quality engineering concepts and tools, e.g. Statistical Process Control (SPC), Capability Analyses, Design of Experiments (DOE’s), and Process Control Plans (PCP).
Geometric Dimensioning & Tolerancing (GD&T) Fundamentals.
Familiarity with Gauge Repeatability and Reproducibility (R&R) for gauging and fixturing.
Strong proficiency in MS Word, Excel, and Outlook.
Strong written and verbal communication skills.
DESIGN QUALITY ENGINEER DIFFERENTIATING KNOWLEDGE, SKILLS & ABILITIES:
Quality Engineers each report through a particular focus of the Quality Management System. All of the knowledge, skills, and abilities listed above are required for all focus areas. The following additional KSAs are required based on specific focus areas.
Design:
A strong working knowledge of ISO 14971.
A working knowledge of Design Controls Management practices and procedures (Design & Development Planning, Design Input, Design Output, Design Review, Design Verification & Validation, Design Transfer, Design Changes, and Design History File).
Demonstrated application of statistical tools and techniques.
Experience with Minitab preferred.
Knowledge of external standards and regulations pertaining to medical devices, specifically the European Medical Device Regulation (EU MDR), and Biocompatibility and Usability standards is preferred.
DESIGN QUALITY 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 (8) 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.
Ability to travel to suppliers on average 25% to support responsibilities defined above (for external Supplier function only).
LSI SOLUTIONS BENEFITS:
Bonus Plan, 401(k) plan with company match, Tuition Assistance, Employee Assistance Program (EAP) and Product Discounts
Paid Designated 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.
