Design Quality Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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About MedTech

Fueled by innovation at the intersection of biology and technology were 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 are searching for the best talent for Design Quality Engineer role to be located at Danvers MA.

The ideal candidate for the Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a role in product risk management cybersecurity change controls and design controls.

This engineer should excel in an environment that embraces teamwork change risk-based decision-making and flexibility. Be ready to make a significant contribution to a dynamic fun multi-disciplinary team where a self-motivated engineer with excellent written and verbal communication skills stands ready to succeed.

Seize the opportunity today to join this collaborative high performing team within the fastest growing business in MedTech. Come join our Abiomed team today!

Key Responsibilities:

• Provide Design Quality Engineering support throughout the product development lifecycle ensure compliance with regulations and internal Quality Management System procedures.
• Provide support to new product development and sustaining engineering projects including review and approval change orders.
• Use technical expertise knowledge and experience to rapidly innovate the companies medical devices for use in chronic heart failure patients.
• Facilitate and conduct risk management activities including development of Risk Management Plans Hazard Analyses Design Failure Modes and Effects Analysis () and Risk Management Reports.
• Participate and review design inputs and design output requirements ensure risk control measures and cybersecurity requirements are transformed into product requirements.
• Participate in V&V activities review verification and validation plan test protocol reports.
• Participate in product cybersecurity activities including product security planning threat analysis cybersecurity risk assessments periodic monitoring and reporting.
• Apply sound systematic problem-solving methodologies in identifying prioritizing communicating and resolving quality issues as related to the position responsibilities.
• Contribute to the success of the Quality System performance measures by completing tasks on time and with a high level of Quality
• Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system as necessary.
• Support 3rd party audits including follow-up on actions and quality department initiatives.
• Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).

Qualifications

Education:

• A minimum of a bachelors degree in engineering or scientific discipline is required. An advanced degree in a related field is also an asset.

Experience and Skills

Required:

• 1 years of work experience in a highly regulated industry is required or equivalent to a masters degree in engineering or scientific discipline. Medical Device and/or pharmaceutical industry is preferred.
• Knowledge of quality system regulation including 21 CFR Part 820 ISO 14971 IEC 62304 QSR ISO 13485 MDSAP and/or MDD/MDR.
• Demonstrated and impactful experience in design control and risk management activities.
• Ability to communicate ideas and information clearly effectively and frequently (oral and written) within the internal project team and international.

Preferred:

• Work experience in a highly regulated industry
• Experience conducting Design Failure Mode Effects and Analysis
• Design control or new product development experience

Other:

• This position will require working onsite in Danvers MA with a minimum of 3 days per week and will require 10% of domestic and/or international travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.