Senior Engineer I - Quality Design & Reliability Assurance

INTEGRA LIFESCIENCES CORP; Irvine (CA); On-site; USD 94,300 - 129,950; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) savings plan

Life insurance and disability benefits

Job summary

INTEGRA LIFESCIENCES CORP is looking for a Senior Engineer II, Quality Design Assurance in Irvine, California. This role involves leading the design and development of medical devices, ensuring compliance with regulatory standards.

The ideal candidate will have a Bachelor's degree in engineering and five years of experience in the medical device industry along with skills in risk management and quality assurance processes.

The position offers a salary range of $94,300 to $129,950, with additional benefits like medical insurance and a 401(k) savings plan.

Qualifications

• Five years of experience in medical device or regulated industry.
• Strong knowledge of Risk Management (ISO14971, ISO13485, FDA QSR).
• Excellent organizational and communication skills.

Responsibilities

• Lead design and development of medical devices.
• Conduct risk analysis activities.
• Support transfer to manufacturing activities.

Skills

Analytical skills

Problem-solving methodology

Design Verification and Validation

Communication skills

Project management

Education

Bachelor’s degree in engineering (Electrical/Electronic preferred)

Tools

MS Office Suite

Statistical software

Job description

Job Overview

The Senior Engineer II, Quality Design Assurance, will work within the Integra Lifesciences CSS Quality organization to support the development of new Medical Devices. Working in the Design Quality team, you should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. You should be willing to make a significant contribution to a multi-discipline team, must be self-motivated to take actions, and have excellent written and verbal communication skills. The position will support line extensions of existing products as part of the new product development process, as well as design related aspects of product and process transfers between manufacturing sites. This position will have responsibility for new product introduction and development to ensure the highest levels of product quality to the end customer. Being able to independently plan and conduct projects and/or assignments with technical responsibilities or strategic inputs with moderately detailed instructions from Leaders and Stakeholders is a must‑have. For this Sr II role, ideal candidate will be a Subject Matter Expert with ISO11607, 10993, and functional cascading system requirements to component drawings, balancing the use of Y14.5 with the needs of the business.

Responsibilities

• Lead and/or support the design and development of medical devices in close collaboration with R&D and external partners, including software requirements and electrical/software architectures.
• Lead and/or support risk analysis activities (FMEAs and SHAs).
• Demonstrate proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis).
• Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes.
• Working knowledge of DFSS techniques, process improvement techniques, and Lean process improvement techniques.
• Proficiency in Design / Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control.
• Conduct and support the development of test methods in equipment, process, and product qualifications/validations.
• Support transfer to manufacturing activities both in product development and base business.
• Contribute to root cause investigations using various problem‑solving techniques and tools and assess the effectiveness of corrective actions.
• Develop inspection methodology and acceptance criteria for inspection sampling plans.
• Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance, Nonconforming Materials, etc.
• Fulfill design control requirements compliant: software specifications, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA, and ISO guidelines.
• Support Design and Technical Review.
• Communicate effectively at all levels within Quality, as well as cross‑functionally with departments such as Research & Development, Regulatory, Marketing and Manufacturing.
• Demonstrate project management and leadership abilities.
• Participate in internal and external audits.
• Maintain the Quality System.

Qualifications

• Bachelor’s degree in engineering (Electrical/Electronic preferred; others considered Mechanical, Systems, Chemical).
• Five years of experience working within a medical device or other regulated industry with knowledge of Risk Management (ISO149712019), EU MDR, MDD, IEC62366, ISO13485, FDA QSR, and cGMP.
• Strong analytical skills and a working knowledge of problem‑solving methodologies.
• Working knowledge of DFSS techniques, process improvement techniques, and Lean process improvement techniques.
• Five years of experience in a Quality Assurance role for medical device or pharmaceutical product development.
• Knowledge of industry best practices and advances in Risk Management practices, processes, tools and technology.
• Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data‑driven decision making.
• Excellent organizational, verbal and written communication skills.
• Proficient with the MS Office Suite and statistical software.
• Must be able to work independently with minimal supervision.
• Able to prioritize projects and manage assigned Design Assurance resources to meet organizational goals and objectives.

Salary & Benefits

Salary Pay Range: $94,300.00–$129,950.00USD. Employees may be eligible for bonus, commission, equity or other variable compensation.

• Medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, and savings plan (401(k)).

EEO Statement

Integra Lifesciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. Integra Lifesciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA.