Engineer Sr. I - QA Design (Remote)
- California
- Permanent
- Full-time
ER Bonus: $7,500.00
Salary Range: Salary Minimum: 109,250
Salary Maximum: 156,687Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Engineer Sr. I - Design Assurance for our Santa Barbara, CA location. The Engineer Sr. I is responsible for various Quality Assurance functions and design development activities of Class I and II medical devices in compliance with FDA, ISO, CMDR Quality Systems and Design Control requirements. This position requires a Bachelor's degree in Engineering and 5+ years' experience in Quality Control or Quality Assurance.Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.This position is eligible for remote work.Essential Duties and Responsibilities:
- Lead design assurance efforts within product design and development for new product introduction projects with an emphasis in quality aspects of integrated software, electrical, and/or mechanical device characteristics, as appropriate for the specific area of position focus.
- For electrical equipment / active device projects, lead compliance efforts for electrical safety, environmental, and emissions in accordance with national and international regulations.
- Ensure appropriateness of documented design requirements and outputs while ensuring traceability throughout the product development lifecycle.
- Provide active leadership in understanding and implementing regulations/standards, acting as a resource to other disciplines, within the product design process from idealization through product retirement.
- Supervise, assign, and coordinate others / the work of others within the design assurance team to support the department and design projects and goals.
- Provide input into and lead addressing of lessons learned to support development, modification, and improvement of design processes and quality management system.
- Lead product risk assessment activities through application of a working knowledge of applicable standards (e.g., ISO14971, etc.) and tools such as (application, design, process) FMEAs, FTA, and Hazard Assessment.
- Display working knowledge and provide guidance to design teams in the area of usability/human factors engineering principles including standards (IEC 62366) and FDA guidance for compliance.
- Facilitate the planning, execution, and review of verification/validation (v&v) activities including assessment of adequate inputs to the v&v process.
- Lead and coordinate the design assurance aspects of Design to Manufacture Transfer including generation of inspection methods, drawing reviews, determining key product indicators/essential requirements and, where appropriate, training of manufacturing personnel in appropriate test procedures, inspection methods, and interpretation of results.
- Ensure required outputs of the design control process are met, including compliance of the design history file (DHF), and support transition of the design project into sustaining engineering.
- Support design-related corrective and preventative activities for projects in the pre-sustaining phase.
- Establish and maintain Risk Management File(s)
- Bachelor's degree in Engineering required; Biomedical, Mechanical, or Electrical Engineering degree preferred.
- 5 years design assurance/quality assurance experience in a medical device or other highly regulated industry required.
- Medical, Dental and Vision Insurance
- Company-Provided Life Insurance
- Voluntary Life Insurance
- Flexible Spending Account (FSA)
- Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
- Matching 401(k) Retirement Plan
- Annual Bonus
- Wellness Incentive Program
- Free Onsite Lunch
- Gym Reimbursement Program
- Tuition Reimbursement Program
- Trip of a Lifetime
- Paid Parental Leave
- Paid Time Off
- Paid Sick Leave
- Volunteer PTO
- Employee Assistance Provider (EAP)