Senior Engineer II — Quality Design & Reliability Assurance

Job overview

The Senior Engineer II — Quality Design & Reliability Assurance role is onsite in Cincinnati, OH. The listed salary range is $82,000–$113,000 per year. The engineer works within Integra LifeSciences’ CSS Quality organization and Design Quality team to support development of new medical devices. The role supports product development, line extensions, and transfers between manufacturing sites while helping ensure product quality. Through design assurance, risk management, verification and validation, and quality system work, the engineer contributes to compliant product introduction and ongoing quality performance.

What you'll do

• Lead or support medical device design and development with R&D and external partners
• support risk analysis including FMEAs and SHAs
• apply statistical methods to establish test plans and evaluate data
• support design and process verification and validation
• develop test methods and support qualifications and validations
• support manufacturing transfers
• contribute to root-cause investigations and corrective action assessment
• develop inspection methods and acceptance criteria
• support quality system processes, design controls, reviews, and audits
• maintain the Quality System. Travel may range from 0% to 50% depending on business needs.

What we're looking for

Skills & competencies

senior engineer ii

quality design & reliability assurance

cincinnati oh

integra lifesciences

medical device development

design assurance

risk management

fmea

verification and validation

iso 13485

travel may be required

$82,000–$113,000/year

Work arrangement

• Weekend coverage required

Benefits & perks

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

Why this role

Senior design assurance role supporting new product introduction and manufacturing transfers; posting highlights ISO 11607, ISO 10993, and requirements cascading to component drawings.

About the employer

Integra LifeSciences is hiring for this role. Industry: Engineering Services. Sector: 54.