Software Design Assurance Engineer - Medical Device Quality

Philips Iberica SAU; Bedford (MA); On-site; USD 102,480 - 163,968; Full time

Benefits offered by this job

Generous PTO

401(k) plan (up to 7% match)

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips Iberica SAU is looking for a Software Design Assurance Engineer in Bedford, MA. This role involves overseeing software quality documentation and ensuring compliance throughout the software lifecycle. You will lead assessments, conduct root-cause analyses, and implement risk management activities.

The ideal candidate has over 5 years in FDA-regulated environments, a strong background in software design assurance, and excellent communication skills. A Bachelor’s degree in a related field is required.

Qualifications

• 5+ years in FDA-regulated medical device software environments.
• Experience with Software Design Control and QMS related to Software Design.
• Ability to communicate software quality standards across levels.

Responsibilities

• Lead assessments of software designs against quality and regulatory standards.
• Conduct root-cause analyses for software quality issues.
• Ensure compliance throughout the product software lifecycle.

Skills

FDA regulations

Risk Management (ISO 14971)

Software Design Assurance

Root-Cause Analysis

Software Validation & Verification

Communication skills

Agile and SAFe methodologies

C/C++/C# programming

Education

Bachelor’s Degree in Quality, Computer Science/Engineering, or similar

Job description

Philips Iberica SAU is looking for a Software Design Assurance Engineer in Bedford, MA. This role involves overseeing software quality documentation and ensuring compliance throughout the software lifecycle. You will lead assessments, conduct root-cause analyses, and implement risk management activities.

The ideal candidate has over 5 years in FDA-regulated environments, a strong background in software design assurance, and excellent communication skills. A Bachelor’s degree in a related field is required.