Sr. Design Assurance Engineer

This position can be Remote or Hybrid.

PURPOSE AND SCOPE

Participate in the New Product Development (NPI) and design changes, Design History File (DHF) and review 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 13485 and ISO 14971 requirements. Must have manufacturing processes understanding and know when certain qualifications and verifications are required. 

PRINCIPAL DUTIES AND 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.

· 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.

· Experience with product lifecycle management from ideation, development, to commercialization along with relevant risk files.

· 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.

· 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.

· Assist with various projects as assigned by a direct supervisor.

· Additional duties and responsibilities may include focus on one or more departments or locations.

PHYSICAL DEMANDS AND WORKING CONDITIONS

· Ability to lift and/or move up to 50 lbs. with assistance.

EDUCATION

· Bachelor’s Degree in related engineering or scientific discipline required; Advanced Degree desirable

EXPERIENCE AND REQUIRED SKILLS

·         5 - 8 years' related experience; or a Master's degree with 3 years' experience; or a PhD without experience; or equivalent directly related work experience. 

·         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.