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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:
R&D/Scientific Quality
Job Category:
Professional
All Job Posting Locations:
Danvers, Massachusetts, United States of America
Job Description:
We are searching for the best talent for Design Quality Engineer role to join our MedTech Quality organization located 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
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, 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:
Support New Product Development projects Risk Management Deliverables
Use technical expertise, knowledge, and experience to rapidly innovate the companies' medical devices for use in chronic heart failure patients
Evaluate end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets which include design for manufacturing, assembly, and automation
Develop and/or review test protocols, reports, and engineering summaries
Perform process development studies in collaboration with cross functional teammates and bring an open mind to design solutions which enable manufacturability internally and at external suppliers
Test and analyze engineering prototypes using statistical analysis in Minitab and apply to the design effort (Multivar chart, t-tests, confidence/reliably analysis, Gauge R&R) to iterate concepts toward extremely innovative yet robust solutions
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
Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP)
Qualifications
Education:
A minimum of a Bachelor's degree is required. Degrees in engineering or scientific discipline is preferred. An advanced degree in a related field is also an asset
Experience and Skills
Required:
A minimum of 6 months of related work experience
Knowledge of quality system regulation, including 21 CFR Part 820, ISO 14971, QSR, ISO 13485, MDSAP and/or MDD/MDR
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 Process / Design Failure Mode Effects and Analysis
Design control or new product development experience
Experience supporting or conducting Process Verification / Validation activities
Experience with Blueprint reading/literacy including GD&T is preferred. Familiarity with inspection methods and techniques
Other:
This position will require to work onsite in Danvers, MA with a minimum of 4 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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers .Internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Agility Jumps, Business Behavior, Compliance Management, Continuous Improvement, Database Backup, Data Gathering and Analysis, Data Savvy, Disruptive Innovations, Execution Focus, Issue Escalation, Process Oriented, Product Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing
The anticipated base pay range for this position is :
$76,000.00 - $121,900.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Sprachkenntnisse
- English
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