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 II 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 Quality Engineer position will lead various New Product Development activities as well as play a role in product risk management, manufacturing qualifications, 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 for our Impella product portfolio, emphasizing on Risk Management.
- 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 MFG 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:- A minimum of a Bachelor's degree in an engineering or scientific discipline is required. An advanced degree in a related field is also an asset.
- Must have in depth knowledge of and ability to apply quality system regulation, including ISO 13485, ISO 14971, 21 CFR 820, MDSAP, EU MDR and others.
- 2+ years of work experience in a highly regulated industry is required or equivalent masters degree in engineering or scientific discipline. Medical Device and/or Pharmaceutical industry is preferred.
- Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international.
- Experience conducting Process / Design Failure Mode Effects and Analysis is an asset.
- Design control or new product development is preferred.
- Experience supporting or conducting Process Verification / Validation activities is preferred.
- Experience with Blueprint reading/literacy including GD&T is preferred. Familiarity with inspection methods and techniques is an asset.
This position will be based in Danvers, MA with a requirement to be on-site 3-4 days per week and will require 10% travel.
If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent's consent for the background check.
#LI-Hybrid
Required Skills:Preferred Skills:Agility Jumps, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Database Backup, Data Savvy, Disruptive Innovations, Issue Escalation, Problem Solving, Process Oriented, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing
The anticipated base pay range for this position is :$92,000.00 - $148,350.00
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
