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Johnson & Johnson · 3 months ago

Sr. Design Quality Engineer

Danvers, Massachusetts, United States of America

Full-time

Hybrid

Mid, Senior Level

$109K/yr - $175K/yr

5+ years exp

Johnson & Johnson is a leader in healthcare innovation, focused on developing smarter and less invasive treatments. The Sr. Design Quality Engineer will support New Product Development and sustain engineering activities, ensuring compliance with quality standards and regulations while facilitating risk management and cybersecurity efforts.

Hospital & Health Care

Comp. & Benefits

H1B Sponsor Likely

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 in reviewing 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)

Qualification

Design ControlRisk ManagementQuality System RegulationMedical Device ExperienceElectro-mechanical DevicesCommunication SkillsTeamworkProblem Solving

Required

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

Minimum 5 years of work experience in a highly regulated industry is required or equivalent to a master's degree in engineering or scientific discipline. Medical Device and/or Biotechnology industry is preferred

Working experience and Knowledge of quality system regulation, including 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR

Experience conducting and furnishing RMF and Design Failure Mode Effects and Analysis

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 electro-mechanical devices

Familiar and working experience in CI tools, reliability and statistical sample size

Benefits

Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

Company

Johnson & Johnson

Glassdoor4.2

At Johnson & Johnson, we believe health is everything.

Founded in 1886

New Brunswick, NJ, US

10001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (48)

2024 (56)

2023 (58)

2022 (59)

2021 (44)

2020 (27)