Principal Design Quality Engineer

Fresenius Medical Care • Lawrence, MA

9d • $117,000 - $196,000

About The Position

Coordinates all efforts for major projects and other significant assignments. Assists in performing disciplined problem solving for supplier, customer, and internal quality defect. Plays an active role in supporting design control activities, concept through release.

Requirements

• 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.
• Ability to read, analyze, interpret common scientific and technical reports, technical procedures, governmental regulations.
• Experience with Correlation and regression Analysis, Experimental Design (DOE), and acceptance sampling; as well as conducting and interpreting gage R&R studies.
• Strong oral and written communication skills.
• Strong computer skills, proficient with Microsoft Office.

Nice To Haves

• Advanced Degree desirable.

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 nonconformance reports (NCR), corrective and preventative actions (CAPA), and material containment and hold forms (MCH) and affected lot hold forms (ALH).
• Utilizes basic statistical techniques, Experimental Design (DOE), Risk Management, Hazard Analysis and Critical Control Point (HACCP), and Failure Modes and Effects Analysis (FMEA). Conducts and interprets Gage Reproducibility and Repeatability (R&R) studies.
• Provides support in coordinating plant risk management activities and ensuring risk management techniques are implemented throughout product lifecycle.
• May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.
• May escalate issues to supervisor/manager for resolution, as deemed necessary.
• May manage and execute testing and release procedures for finished products.
• Mentors other staff as applicable.
• Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
• Assists with various projects as assigned by a direct supervisor.
• Other duties as assigned.
• Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
• Deep understanding and experience with Risk Management techniques associated with ISO14971-2019. Includes creation of Risk Management Plans, Hazard Analysis/Risk Analysis, Risk Management Reports.
• Understanding Risk linkages to CAPAs, SCARs, NCMRs, complaint handling, and overall quality system.
• Understanding and experience of applying Risk Activities required to support post-market surveillance.
• Understanding and experience applying supportive risk management tools such as dFMEAs, pFMEAs, Use Error Analyses, SW Risk analyses.
• Understanding and applying use of Harms libraries, P1 values, P2 values in premarket and post market settings.
• Ability to review and oversee quality system procedures related to risk management and risk related techniques.
• Deep understanding and experience with Design Control techniques including Design Planning, Design Inputs, Design Outputs, Design Reviews, Design Verification, Design Validation, Design Changes, Design Transfer, and Design History Files (Design and Development Files).
• Understanding and experience with applying Design Control linkages to Mfg. Process development and Process Validation.
• Understanding and experience with how Design Controls link into other facts of a quality management system.
• Understanding and experience applying Statistical Techniques in a Design Control context for Design Verification and Validation.
• Understanding of Human Factors/Usability Engineering processes and techniques.

Benefits

• medical, dental, and vision insurance
• a 401(k) with company match
• paid time off
• parental leave
• potential for performance-based bonuses depending on company and individual performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal