Engineer Senior I - QA Design (Electromechanical)

Arthrex GmbH; Santa Barbara (CA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

Voluntary Life Insurance

Flexible Spending Account (FSA)

Supplemental Insurance Plans

Matching 401(k) Retirement Plan

Annual Bonus

Wellness Incentive Program

Free Onsite Lunch

Tuition Reimbursement Program

Paid Time Off

Employee Assistance Provider (EAP)

Job summary

Arthrex, Inc. in Santa Barbara, CA is seeking a Sr. I Engineer – QA Design to drive design assurance across product design and development, ensuring regulatory and patient safety standards are met throughout the lifecycle.

You will lead risk assessments, usability, V&V planning, design transfers, and DHF compliance, collaborating with electrical, mechanical, and software teams to bring new and sustaining medical devices to market.

Qualifications

• Bachelor’s degree in Engineering is required; Biomedical/Mechanical/Electrical preferred.
• Minimum 5 years in design assurance/quality in medical devices.
• Working knowledge of ISO and FDA design and development quality requirements.

Responsibilities

• Lead design assurance efforts for new product introductions with software/electrical/mechanical focus.
• Lead compliance for electrical safety and emissions per regulations.
• Ensure traceability of design requirements across development lifecycle.
• Lead design teams on usability/human factors per IEC 62366 and FDA guidelines.
• Plan, execute, and review verification/validation activities.
• Drive Design to Manufacture Transfer with inspection methods and training.
• Ensure DHF outputs meet design control requirements.
• Support corrective and preventive actions pre-sustaining.

Skills

Design Assurance

FDA Regulations

ISO Standards

Risk Assessment

V&V Planning

Electrical/Mechanical/Software

GD&T

DOE

SAP

Windchill

CodeBeamer

CAD/CAM

Education

Bachelor's degree in Engineering

5 years design assurance experience in medical devices

Tools

SAP

CodeBeamer

Windchill

CAD/CAM

Job description

Engineering - Santa Barbara, CA, US, 93111

Arthrex, 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 – QA Design who is responsible for interfacing and driving Design Assurance principles within engineering teams for design, development transfer and post-market surveillance of FDA Class I and II, EU Class I, IIa, IIb and III medical devices in the achievement of company goals. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

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.
• 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.

Education and Experience:

• 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.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Working knowledge of ISO and FDA design and development quality requirements.

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

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

Proficiency in assessing manufacturing quality requirements of new product concepts.

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

Machine, Tools, and/or Equipment Skills:

Proficiency with PC operations, and the Microsoft Office suite, and CAD/CAM Software. Hands on experience with SAP, Codebeamer and Windchill preferred.

Reasoning Ability:

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

Mathematical Skills

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

Language and Communication Skills:

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

• 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
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Time Off
• Employee Assistance Provider (EAP)

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