Sr Design Quality Engineer
Company: Disability Solutions
Location: Danvers
Posted on: May 2, 2024
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Job Description:
Abiomed, a part of Johnson & Johnson MedTech, is currently
recruiting for a Sr. Design Quality Engineer to be based in
Danvers, MA, onsite 3 days a week. At Johnson & Johnson, we believe
health is everything. Our strength in healthcare innovation
empowers us to build a world where complex diseases are prevented,
treated, and cured, where treatments are smarter and less invasive,
and solutions are personal. Through our expertise in Innovative
Medicine and MedTech, we are uniquely positioned to innovate across
the full spectrum of healthcare solutions today to deliver the
breakthroughs of tomorrow, and profoundly impact health for
humanity. Learn more at https://www.jnj.com/. Abiomed, part of
Johnson & Johnson MedTech, is a leading provider of medical devices
that provide circulatory and respiratory support, with a mission of
recovering hearts & saving lives. Abiomed's "Patients First!"
culture drives our skilled workforce and strong relationships with
clinicians. Our innovative product portfolio and robust pipeline
provide us the incredible opportunity to bring lifesaving
technology to more patients around the world than ever before.
Founded in 1981, Abiomed has a proven track record for growth,
integrity and innovation. This Senior Design Quality Engineer
position is responsible for various Design Quality Engineering
functions in support of product development such as risk
management, design verification, design validation, design
assurance activities, as well as manufacturing process development
support, and statistical analysis. This role's emphasis will be in
support of Abiomed's new PreCARDIA system's continued development
through Early Feasibility Studies on its way to full
commercialization. Primary Duties and Responsibilities: The
following duties and responsibilities are intended to be
representative of the work performed by the incumbent(s) in this
position and are not all-inclusive. The omission of a specific duty
or responsibility will not preclude it from the position: ---
Support Design Quality Engineering activities in support of
Abiomed's Product Development and Life Cycle processes including
design controls, quality planning, risk management assessments,
design reviews, test method development and validation, design
verification and validation test plans, protocols and reports ---
Ensure that Design controls are compliant with all relevant
regulations (FDA, ISO13485, EU MDR, PMDA) --- Lead, conduct and own
risk management activities including Hazard Analysis, System Risk
Analysis, and various FMEAs (Design, Use, Process) --- Ensure
compliance to ISO14971 and implementation of Risk Management best
practices --- Ensure that FDA and other regulatory knowledge and
experience is applied to risk and testing assessments --- Work with
manufacturing engineering and contract manufacturing partners to
ensure necessary process controls are in place for initial product
launch and significant design changes --- Review and approve Change
Requests and Engineering Change Orders (ECO) as needed --- Act as
an effective team member in the execution of Quality functions in
compliance with FDA QSRs (Design Control, CAPA, etc.), ISO 13485,
ISO 14971, IEC 62366, MDR, CMDR, CMDCAS and other national and
international quality and regulatory requirements and standard ---
Contribute to the design, development, and implementation of
product assurance plans providing feedback to corrective and
preventative actions to engineering, manufacturing, service and
field operations and supplier performance --- Develop statistically
sound sampling plans and perform data analysis --- Assess
reliability growth strategies for the product and provide input to
the engineering teams --- Build and maintain strong interpersonal
relationships within and outside of the company
Keywords: Disability Solutions, Concord , Sr Design Quality Engineer, Engineering , Danvers, New Hampshire
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