Advanced Manufacturing Quality Engineer

Becton Dickinson Medical Devices•Warwick, RI

10d•Onsite

About The Position

Represent quality on design teams and assure that new and sustaining product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy. Be an active team member and cross-function collaborator on new product development and product sustaining project teams for implantable medical devices. Be an active team member for investigating quality complaints, examining non-conformances and executing CAPAs. We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Requirements

Bachelor Degree in Engineering or Technical Sciences and 2 years experience OR Masters' Degree and 1 year experience in Quality Engineering or related discipline including design controls, product/process validation, risk management, and technical problem solving.
A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability.
Strong Design Control understanding from concept to launch; especially in post-market activities (including complaints, failure investigations, and CAPAs).
Applied Knowledge of the requirements of FDA QSR, ISO13485, ISO14971, and ISO 9001.
Proven track record of developing new products that meet customer expectations.
Prior experience as a quality engineer lead on new product development teams.

Nice To Haves

Prior experience with combination products and absorbable technologies a plus.
Prior experience interacting with Surgeons
Knowledge of statistics and experience with statistical software (e.g. MiniTab), preferred.

Responsibilities

Technical Leadership & Mentorship - Provide expert guidance to Quality Engineers, Technicians, and Inspectors.
Regulatory Excellence - Develop comprehensive test protocols and final reports that support critical regulatory submissions including 510K, PMA, CE mark, and international registrations.
Innovation Partnership - Collaborate with our R&D teams to support Pre-Concept Front End Product Innovation Process activities, helping bring groundbreaking technologies to life.
Project Leadership - Spearhead Quality Engineering initiatives aimed at enhancing our quality systems and procedures, driving continuous improvement across the organization.
Risk Management - Create sophisticated design risk assessments while coordinating input from cross-functional team members and managing comprehensive risk files for medical devices.
Design Verification & Validation - Develop robust protocols and detailed reports for both verification and validation processes, including critical data analysis and design acceptability decisions.
Design Control Documentation - Contribute valuable insights to all phases of design control documentation as defined by our established product development process.
Biocompatibility Expertise - Determine appropriate biocompatibility testing requirements per ISO10993 and company procedures, working alongside subject matter experts to coordinate testing and document results.
Test Method Development - Create or enhance inspection and test methods aligned with product specifications, ensuring the highest quality standards.
Shelf Life & Stability Studies - Design and execute comprehensive protocols and deliver detailed final reports supporting product expiration dating, Shelf Life and Stability Studies.
Test Method Validation - Perform rigorous validations ensuring accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods critical for device safety and efficacy.
Manufacturing Control Systems - Develop and document robust control systems for new products, including detailed inspection plans for components, sub-assemblies, and final products.
Process Control Planning - Support the development of manufacturing control plans for both internal and outsourced processes, ensuring consistency and quality.
Process Risk Assessment - Lead or support the development of thorough process risk assessments to identify and mitigate potential issues.
Process Development - Conduct comprehensive studies to determine the acceptability of new processes or equipment, driving manufacturing excellence.
Inspection Method Design - Create and qualify innovative inspection test methods and equipment to enhance quality control processes.
Supplier Quality Management - Provide expert Quality Engineering support to outsourced analytical laboratories and manufacturing facilities, ensuring compliance with 21CFR 820, 210, 211; cGMPs, and ISO13485:2003 requirements.
Supplier Qualification - Lead critical supplier part qualification activities including mold qualification and Design of Experiments (DOEs).
Production Transfer Support - Facilitate smooth process transfers to production facilities, ensuring quality is maintained throughout scaling operations.
Quality Analytics - Generate detailed quality information reports showcasing trends and demonstrating the impact of process improvements.
CAPA Implementation - Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances.
Statistical Analysis - Perform DOEs and other advanced statistical analyses to support product and process optimization or determine causes of process variation, initiating corrective actions as needed.
Technical Problem-Solving - Provide expert technical support to resolve quality challenges across development, pilot, manufacturing, or supplier operations.
Quality Assurance Alignment - Support the strategic goals of the Quality Assurance Department, contributing to our culture of excellence.