Sr. Design Quality Engineer at Johnson & Johnson

Danvers, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s degree in engineering or scientific discipline (minimum required); advanced degree in a related field is an asset
Minimum 5 years of work experience in a highly regulated industry (or equivalent to a master’s degree in engineering or scientific discipline); Medical Device and/or Biotechnology industry preferred
Working experience and knowledge of quality system regulations

Responsibilities

Provide Design Quality Engineering support throughout the product development lifecycle to ensure compliance with regulations and internal Quality Management System procedures
Provide support to new product development and sustaining engineering projects, including review and approval of change orders
Use technical expertise, knowledge, and experience to rapidly innovate the company’s 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 (DFMEA), and Risk Management Reports
Participate in reviewing design inputs and design output requirements; ensure risk control measures and cybersecurity requirements are transformed into product requirements
Participate in Verification and Validation (V&V) activities; review verification and validation plans and 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 related to position responsibilities
Contribute to the success of 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 Quality Management System (QMS) through authoring and updating Standard Operating Procedures (SOPs)

Skills

Key technologies and capabilities for this role

Design ControlsRisk ManagementCybersecurityChange ControlsQuality EngineeringProduct DevelopmentRegulatory Compliance

Questions & Answers

Common questions about this position

Is this a remote position or does it require on-site work?

The role is located in Danvers, Massachusetts, indicating it is an on-site position.

What are the key responsibilities of the Sr. Design Quality Engineer?

Key responsibilities include providing Design Quality Engineering support throughout the product development lifecycle, facilitating risk management activities, participating in design reviews, V&V activities, and product cybersecurity.

What skills and qualities are ideal for this role?

The ideal candidate excels in teamwork, change, risk-based decision-making, flexibility, and has excellent written and verbal communication skills, along with technical expertise in quality engineering for medical devices.

What is the company culture like for this team?

The team is described as collaborative, high-performing, dynamic, fun, and multi-disciplinary within the Abiomed team at Johnson & Johnson MedTech.

What makes a strong candidate for this Sr. Design Quality Engineer position?

A strong candidate is self-motivated with excellent communication skills, technical expertise in medical device quality engineering, and thrives in a teamwork-oriented environment focused on innovation and risk management.

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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