Design Quality Engineer
About The Position
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!
Requirements
- 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
- 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
Nice To Haves
- 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
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)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
