Senior Medical Device Quality Engineer – Development & Compliance

Abbott; Iowa (LA); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Tuition reimbursement

Education benefits

Job summary

Abbott's Electrophysiology division in Plymouth, MN seeks a Senior Engineer to lead development and sustaining activities for complex medical devices, focusing on disposable catheters. You will guide design verification/validation, run analyses, and mentor junior engineers in a multidisciplinary team.

The role requires a bachelor’s in engineering, 6+ years in new product development, and strong regulatory knowledge. On-site work in Plymouth with ~10% travel; Abbott offers extensive benefits.

Qualifications

• Bachelor's degree in Engineering or technical field.
• Minimum 6 years in new product development.
• Experience with design verification and design validation.
• Knowledge of statistics and DOE; with Minitab.
• Willingness to travel ~10%, including international.
• FDA/IEC 60601, GMP, ISO 13485, ISO 14971 knowledge; medical device experience preferred.

Responsibilities

• Lead complex development projects and quality improvements.
• Drive cross-functional strategies for compliant and efficient solutions.
• Train and develop other engineers.
• Execute design verification/validation strategies.
• Lead root cause investigations and CAPA.
• Ensure DHF content integrity and regulatory compliance.
• Represent the team during FDA/ISO inspections.
• Support establishment of customer and product requirements.
• Support QMS/EMS initiatives and regulatory adherence.
• Perform other related duties as assigned.

Skills

Design verification

Design validation

Applied statistics

Minitab

Regulatory knowledge

Cross-functional

Travel willingness

Medical device experience

Education

Bachelor's degree

Job description

Abbott's Electrophysiology division in Plymouth, MN seeks a Senior Engineer to lead development and sustaining activities for complex medical devices, focusing on disposable catheters. You will guide design verification/validation, run analyses, and mentor junior engineers in a multidisciplinary team.

The role requires a bachelor’s in engineering, 6+ years in new product development, and strong regulatory knowledge. On-site work in Plymouth with ~10% travel; Abbott offers extensive benefits.