Principal Design Quality Engineer

Katalyst CRO; Waukesha (WI); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking an experienced Quality Engineer specialized in design control to lead design history file reviews, risk management, and regulatory compliance for medical device development. You will guide engineering teams, review DHF/DMR deliverables, and ensure quality by design across NPI projects.

The role requires deep knowledge of FDA/ISO requirements, strong multitasking, and the ability to mentor junior staff while coordinating cross-functional activities across multiple

Qualifications

• Bachelor's degree is required; advanced degree preferred.
• 8–12+ years of experience, or 6+ years with master's.
• Familiar with DHF, DMR, risk management, design verification and validation.
• Ability to multi-task in a fast-paced environment.
• Strong organizational and presentation skills.
• Excellent written and verbal communication.

Responsibilities

• Resolve issues in creative ways within the design control process.
• Ensure projects meet customer expectations and regulatory requirements.
• Act as a subject matter expert on design control and Quality Engineering.
• Address complex engineering issues with in-depth evaluation of variable factors.
• Provide guidance to engineering staff and ensure design control requirements are met.
• Input to DHF deliverables including material specs, drawings, inspection procedures, and manufacturing procedures.
• Review and approve design control related Change Notices (CNs).
• Coordinate Design Assurance activities of other team members.
• Create processes and improvements to ensure internal and external regulatory compliance.
• Represent design quality functions for review and approval of design outputs.
• Assist in development and maintenance of procedures for design control, change management, risk management and PV.
• Represent QA to FDA, ISO and auditors.
• Work independently on high visibility NPD projects across technologies and sites.
• Maintain knowledge of regulatory requirements and standards for development and release of medical devices.
• Provide mentorship to junior staff and escalate issues as needed.
• Assist with various projects as assigned by supervisor.
• Other duties as assigned.

Skills

Design control process

Quality Engineering

Regulatory compliance

Mentorship

Leadership

Education

Bachelor's Degree

Advanced Degree

Job description

Job Description

Participate in the New Product Development (NPI) and design changes, Design History File (DHF) and Device Master Record (DMR) reviews meetings and fully understand the design control process and Quality Engineering. Utilize technical training and compliance experience to ensure that company design control projects comply with internal design control procedures in accordance with FDA and ISO requirements.

• A seasoned, experienced professional with a full understanding of design control process; resolves a wide range of issues in creative ways.
• Responsible for assuring projects meet customer expectations, and regulatory requirements.
• Act as a subject matter expert on design control process and Quality Engineering. The Quality Engineering subjects are Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV).
• Successfully address complex engineering issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Provide guidance to engineering staff and other personnel, and ensure that design control requirements are being met in an effective manner in order to achieve quality by design, including those for design verification, validation, specification and procedure development, risk management, and design review.
• Provides input to design and manufacturing engineering project DHF deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF files for accuracy and completeness and provide guidance on FDA compliance and procedures.
• Review and approve design control related Change Notices (CNs) within the documentation system as applicable.
• Coordinate the Design Assurance activities of other team members and assist staff with complex tasks that may require considerable judgment and initiative.
• Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards.
• Represent the design quality functions for the review and approval of designated design outputs.
• Assist in the development and maintenance of company procedures for design control, change managements, risk management, process validation and related areas of the quality management system.
• Represent the design quality assurance department to FDA, ISO and all other auditors.
• Work independently on high visibility new product development projects; including projects involving multiple technologies and design sites.
• Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
• Provide mentorship and assistance to junior level staff with more complex tasks that require a higher level of understanding of functions, and escal... issues to supervisor/manager for resolution, as necessary.
• Assist with various projects as assigned by a direct supervisor.
• Other duties as assigned.

Roles & Responsibilities

• A seasoned, experienced professional with a full understanding of design control process; resolves a wide range of issues in creative ways.
• Responsible for assuring projects meet customer expectations, and regulatory requirements.
• Act as a subject matter expert on design control process and Quality Engineering. The Quality Engineering subjects are Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV).
• Successfully address complex engineering issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Provide guidance to engineering staff and other personnel, and ensure that design control requirements are being met in an effective manner in order to achieve quality by design, including those for design verification, validation, specification and procedure development, risk management, and design review.
• Provides input to design and manufacturing engineering project DHF deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF files for accuracy and completeness and provide guidance on FDA compliance and procedures.
• Review and approve design control related Change Notices (CNs) within the documentation system as applicable.
• Coordinate the Design Assurance activities of other team members and assist staff with complex tasks that may require considerable judgment and initiative.
• Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards.
• Represent the design quality functions for the review and approval of designated design outputs.
• Assist in the development and maintenance of company procedures for design control, change managements, risk management, process validation and related areas of the quality management system.
• Represent the design quality assurance department to FDA, ISO and all other auditors.
• Work independently on high visibility new product development projects; including projects involving multiple technologies and design sites.
• Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
• Provide mentorship and assistance to junior level staff with more complex tasks that require a higher level of understanding of functions, and escal... issues to supervisor/manager for resolution, as necessary.
• Assist with various projects as assigned by a direct supervisor.
• Other duties as assigned.

Requirements

• Bachelor's Degree required; Advanced Degree preferred.
• Bachelor's degree and 8-12+ years of experience or a master's degree and 6+ years of experience preferred.
• Familiar with critical elements of the design history file including risk management, design verification and validation tests and ensuring compliance of these elements to procedural requirements.
• Ability to multi-task and operate within a fast-paced environment.
• Strong organizational and presentation skills required.
• Excellent oral, written, analytical, computer and interpersonal skills.