Senior Design Quality Engineer I

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

We are searching for the best talent for a Senior Design Quality Engineer I to be based in Danvers, MA.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech.

Purpose: This person will have the opportunity to perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products!  Activities will include risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support statistical analysis and more! This role’s emphasis will be in support of Abiomed’s existing single-use heart pumps.

You will be responsible for:

• Support and lead Design Assurance engineering activities in support of Abiomed’s Life Cycle processes including design controls, quality planning, risk assessments/analysis/management, design reviews, test method development and validation, design and process verification and validation test plans and reports, post-market monitoring, investigations, follow-up and reporting.

• Expertly navigate existing FMEA’s and Hazard Analysis in support of sustaining and lifecycle activities.

• Ensure that FDA and other regulatory knowledge and experience is applied to risk and testing assessments.

• Work with manufacturing engineering to ensure necessary process controls are in place for design changes.

• Review and approve Engineering Change Requests (CR’s) and support the Non-Conformance (NC’s) process as necessary.

• Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc), ISO 13485, MDD, CMDR, CMDCAS and other national and international quality and regulatory requirements and standard.

• Contribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance.

• Collect, analyze & report on quality system metrics: CAPA, complaint trends, manufacturing trends, etc.

• Develop statistically sound sampling plans and perform data analysis.

• Participate in design reviews for the system as well as review and approve design input/design requirements, design documents, test results, verification and validation.

• Be a voice of quality and ensure compliance to internal & external quality standards.

• Bring ideas that challenges curent thinking.

• Serve as a 'go-to' for quality & multi-functional team members.

• Independent decision maker, provides strategic solutions to multi-functional team with minimal guidance from leadership.

• Mentor Newer QE’s on business practices and quality tasks.

 

Qualifications/Requirements:

• Bachelor degree in Engineering or Sciences is required.

• Minimum of 8 years of quality experience.

• Experience in the medical device industry highly preferred.