Senior Design Assurance Engineer

Job Description

The Sr. Design Assurance Engineer position will support design assurance activities for Bracco Medical Technologies (BMT) products. This role is responsible for providing support for Design Verification and Validation activities while ensuring compliance to BMT design control procedures and applicable regulations and external standards.

Primary Duties & Responsibilities:

Design Assurance - Consumables

• Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements associated to consumable, software, electrical, and mechanical products.
• Drive the Design Control process and own the Design History File (DHF) within the framework of regulatory requirements.
• Ensure that specifications and requirements are relevant, capable, contain essential elements and meet applicable standards, and that all requirements are suitably testable and verified.
• Provide guidance and support for design verification activities. Assess protocols and reports test robustness, traceability to requirements, and statistical sample sizes, and quality of the test specifications.
• Work with Engineering to develop production acceptance criteria, test methods, and process validation protocols.
• Lead risk management activities from planning, analysis and verification, and risk reporting and acceptance for the assigned areas of responsibility.
• Provide support and guidance for testing qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.
• Generate the QA deliverables to meet the project scope and plan.
• Review, provide input, and approve project-related deliverables and change orders.
• Work with external design/test organizations to ensure Design Control requirements are fulfilled and appropriate supplier controls are in place.
• Review Design History Files and Technical Files for conformance to applicable requirements.

• Prepare technical sections of regulatory approval applications by identifying the testing needed to support global submissions.

Required Skills

Minimum

• Where permitted by applicable law, must have received or be willing to receive the COVID-19 vaccine by date of hire to be considered for U.S.-based job, if not currently employed by ACIST Medical Systems
• B.S. in Mechanical Engineering, Material Science, or related equivalent experience with engineering or science degree
• 5+ years of engineering experience.
• 3+ years of experience in a Quality Engineering/Design Assurance capacity in the medical device industry, preferably with catheter and single use devices.
• Experience managing design assurance/quality engineering deliverables for medical device systems (e.g. medical devices that utilize electro-mechanical components, catheters, and associated consumable devices)
• Strong working knowledge of the FDA Quality System Regulation, ISO 13485, the Medical Device Directive and Medical Device Regulations
• Demonstrated knowledge and proficiency in the application of ISO 14971 and other standards related to product design and medical devices
• Demonstrated knowledge and proficiency in quality principles and best practices
• Strong collaboration skills to effectively communicate with both business and technical teams
• Effective oral and written communication skills
• Moderate level of computer proficiency including MS Word, Excel, and statistical applications software
• Effective technical writing skills
• Ability to work independently
• Ability to travel both domestically and internationally
• Demonstrated knowledge and proficiency in problem solving, root-cause analysis, and corrective and preventative actions
• Demonstrated knowledge and proficiency in statistics, data analysis and trending, and reporting of results.

Preferred:

• Advanced degree in Mechanical Engineering or similar discipline
• ASQ CQE (Certified Quality Engineer) or similar certification
• Experience with catheters and/or medical device consumables design, product development, and manufacturing
• Skilled in the application of statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments
• Demonstrated project management skills

Other:

• Travel expected to be less than 10%.