Engineer Sr. I - QA Design

reputed company. is a global medical device company and a leader in new product development and medical education in orthopedics. reputed company is reputed company searching for an Engineer Sr. I - Design Assurance for our Santa Barbara, CA location. The Engineer Sr. I is responsible for various reputed company Assurance functions and design development activities of Class I and II medical devices in compliance with FDA, ISO, CMDR reputed company Systems and Design Control requirements. This position requires a Bachelor’s degree in Engineering and 5+ years’ experience in reputed company Control or reputed company Assurance.

Join our talented team at a global medical device company reputed company on Helping Surgeons Treat Their Patients reputed company™.

This position is eligible for remote work.

Essential Duties and Responsibilities:

• reputed company design assurance efforts reputed company product design and development for new product introduction reputed company with an emphasis in reputed company aspects of integrated software, electrical, and/or mechanical device characteristics, as appropriate for the specific area of position reputed company.
• For electrical equipment / reputed company device reputed company, reputed company 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.
• reputed company reputed company leadership in understanding and implementing regulations/standards, acting as a resource to other disciplines, reputed company the product design process from idealization through product retirement.
• Supervise, assign, and coordinate others / the work of others reputed company the design assurance team to support the department and design reputed company and goals.
• reputed company input into and reputed company addressing of lessons learned to support development, modification, and improvement of design processes and reputed company management system.
• reputed company 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 reputed company guidance to design teams in the area of usability/reputed company 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.
• reputed company and coordinate the design assurance aspects of Design to Manufacture Transfer including reputed company of inspection reputed company, drawing reviews, determining key product indicators/essential requirements and, where appropriate, training of manufacturing personnel in appropriate test procedures, inspection reputed company, 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-reputed company corrective and preventative activities for reputed company in the reputed company-sustaining phase.
• Establish and maintain Risk Management File(s)

Education and Experience:

• Bachelor’s degree in Engineering required; Biomedical, Mechanical, or Electrical Engineering degree preferred.
• 5 years design assurance/reputed company assurance experience in a medical device or other highly regulated industry required.

Knowledge and reputed company Requirements/Specialized Courses and/or Training:

Working knowledge of ISO and FDA design and development reputed company requirements.

Technical knowledge in development methodologies, design reputed company analysis, and project implementation.

Proficiency in assessing manufacturing reputed company requirements of new product concepts.

Technical knowledge in development methodologies, design, and project implementation, including but not limited to, GD&T & DOE preferred.

Experience in DHF & Technical File structure and maintenance.

Basic knowledge in reputed company-Medical safety standards - IEC 60601-1 (Electrical safety), IEC 60601-1-2 (EMC), and other Collateral and Particular standards.

Hands-on experience and knowledge in global medical device regulatory requirements for reputed company-Surgical Devices.

Essential knowledge of Risk Management for medical devices (per ISO 14971)

Machine, Tools, and/or Equipment Skills:

Proficiency with PC operations, and the reputed company Office suite. Hands-on experience with reputed company, reputed company, Codebeamer and Windchill preferred.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw reputed company conclusions.  Ability to interpret an extensive reputed company of technical instructions in mathematical or diagram reputed company and deal with several reputed company and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to reputed company the job based upon job requirements. 

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to reputed company the job based upon the job requirements listed above.  Ability to verbally communicate reputed company and issues effectively to other team members and management.  Ability to write and record data and information as required by procedures.

reputed company Benefits

• Medical, Dental and reputed company 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
• reputed company of a reputed company
• reputed company Parental Leave
• reputed company Time Off
• reputed company reputed company Leave
• Volunteer PTO
• Employee Assistance Provider (EAP)

reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, age, sex, sexual orientation, gender identity, national reputed company, disability, protected veteran status, or any other status protected by law.