Senior Engineer I — Quality Design Assurance

Job overview

The Senior Engineer I — Quality Design Assurance role is onsite in Cincinnati, OH. The listed salary range is $71,000–$98,000 per year. The position works within Integra LifeSciences’ CSS Quality organization and Design Quality team to support development of new medical devices. The engineer helps ensure new products, line extensions, and product or process transfers meet quality requirements. Through design controls, risk analysis, verification and validation, and cross-functional collaboration, the role contributes to product quality and successful introduction to manufacturing.

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.

What we're looking for

Skills & competencies

senior engineer i

quality design assurance

cincinnati oh

integra lifesciences

medical device development

design controls

risk management

fmea

verification and validation

iso 13485

quality assurance

$71,000–$98,000/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

Design Quality role supporting new product introduction, line extensions, and manufacturing transfers; ideal candidate has expertise in ISO 11607, ISO 10993, and requirements cascading to component drawings.

About the employer

Integra LifeSciences is hiring for this role. Industry: Professional and Management Development Training. Sector: 61.