Senior Design Quality Engineer - Risk & Design Control

Freseniusmedicalcare; Lawrence (MA); On-site; USD 117,000 - 196,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid time off

Parental leave

Performance-based bonuses

Job summary

Fresenius Medical Care is seeking an Engineer with a focus on Risk Management and Design Assurance to support ISO14971-2019 risk activities, CAPAs, and post-market surveillance. The role involves cross-functional collaboration in quality systems and design controls, with emphasis on Risk Management Plans and Hazard Analysis.

The position requires a Bachelor’s degree (advanced preferred) and 5–8 years of related experience, or a Master’s with 3+ years, along with strong analytical and reporting

Qualifications

• Bachelor’s Degree required; Advanced Degree desirable.
• Minimum 5–8 years of related experience; or a Master’s degree with 3 years’ experience.
• Strong analytical & troubleshooting skills.
• Ability to understand and employ mathematics at an engineering or scientific level.
• Strong technical report writing skills.
• Strong computer skills, proficient with Microsoft Office.

Responsibilities

• Coordinates timely and complete investigations within the assigned manufacturing plant.
• Ensures compliance to all state and Federal regulations and requirements.
• Composes and executes design and process verification and validation protocols and reports.
• Reviews and approves protocols and reports written by other staff as appropriate.
• Investigates root cause solutions for product release through NCR, CAPA, and MCH/ALH.
• Utilizes statistical techniques, DOE, Risk Management, HACCP, and FMEA; conducts R&R studies.
• Supports plant risk management activities and ensures risk management techniques are implemented.
• May assist junior staff with complex tasks and escalate as needed.
• May manage and execute testing and release procedures for finished products.
• Mentors other staff; adheres to Code of Business Conduct and policies.

Skills

Analytical skills

Troubleshooting

Mathematics proficiency

Technical reporting

Communication skills

Gage R&R/DOE

Education

Bachelor’s degree

Advanced degree preferred

Tools

Microsoft Office

Job description

Fresenius Medical Care is seeking an Engineer with a focus on Risk Management and Design Assurance to support ISO14971-2019 risk activities, CAPAs, and post-market surveillance. The role involves cross-functional collaboration in quality systems and design controls, with emphasis on Risk Management Plans and Hazard Analysis.

The position requires a Bachelor’s degree (advanced preferred) and 5–8 years of related experience, or a Master’s with 3+ years, along with strong analytical and reporting