Johnson & Johnson MedTech · 6 days ago
Sr. Design Quality Engineer
Danvers, MA
Full-time
Onsite
Mid, Senior Level
$109K/yr - $175K/yr
5+ years expJohnson & Johnson MedTech is committed to healthcare innovation, focusing on developing smarter and less invasive treatments. The Sr. Design Quality Engineer will support new product development and sustaining activities while managing product risk, cybersecurity, and design controls.
Hospital & Health Care
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
Required
A minimum of a bachelor's degree in engineering or scientific discipline is required
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
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 MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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