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Abiomed · 3 days ago
Design Quality Engineer II
Danvers, MA
Full-time
Onsite
Mid Level
4+ years exp
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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 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).
Qualification
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Required
A minimum of a Bachelor's degree in an engineering or scientific discipline is required.
A minimum of 4 years of professional working experience is required.
A minimum of 1+ years of work experience in a highly regulated industry is required or equivalent master’s degree in engineering or scientific discipline.
Must have in-depth knowledge of and ability to apply quality system regulation, including QSR, ISO 13485, MDSAP and MDD/MDR.
Working knowledge and practical application of 21 CFR Part 820, ISO 13485, and ISO 14971 is required.
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international.
Preferred
An advanced degree in a related field is an asset.
Medical Device and/or Pharmaceutical industry experience is preferred.
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.
Company
Abiomed
Abiomed is a provider of mechanical circulatory support devices and offers a continuum of care to heart failure patients.
1,001-5,000 employees
H1B Sponsorship
Abiomed 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
Trends of Total Sponsorships
2023 (7)
2022 (16)
2021 (20)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
unknown2022-11-01Acquired· by Johnson & Johnson ($16.6B)
2011-12-29Post Ipo Equity· Undisclosed
1987-08-07IPO· nasdaq:ABMD
Leadership Team
Todd Tetreault
Chief Financial Officer
Will Danzinger
Chief Operating Officer
Recent News
The Business Journals
2024-04-25
2024-04-25
Company data provided by crunchbase
