Senior Design Quality Assurance Engineer - Integrations
Company: Boston Scientific
Location: Marlborough
Posted on: May 8, 2024
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Job Description:
Additional Location(s): N/A Diversity - Innovation - Caring -
Global Collaboration - Winning Spirit - High Performance At Boston
Scientific, we'll give you the opportunity to harness all that's
within you by working in teams of diverse and high-performing
employees, tackling some of the most important health industry
challenges. With access to the latest tools, information and
training, we'll help you in advancing your skills and career. Here,
you'll be supported in progressing - whatever your ambitions. About
the Role : At Boston Scientific, the Design Assurance Engineer
Integrations is a quality engineer that directly supports medical
device product development and integration from an acquired system
to BSCs Quality system, including design controls. This individual
will work with high-performance cross-functional development team
to ensure safety, quality and compliance of acquired products while
continuously improving their commercial value. Initially, this
position supports the transition of the acquired devices to meet
regulations and BSC requirements. This position is part of the
design site for the Endoscopy division and can support activities
including but not limited to New Product Development, Sustaining
and Life Cycle Management and Quality Systems initiatives as they
relate to design and development. Provides quality engineering
support to operations, product development and sustaining projects
for current products on the market. Develops, establishes, and
maintains quality-engineering methodologies, systems, and practices
which meet BSC, customer, and regulatory requirements. Serves as a
Quality representative to improve awareness, visibility, and
communication on quality initiatives to support assigned
departmental, functional, site, divisional and corporate quality
goals, and priorities. Provides quality engineering support within
acquired products, technical development projects, new product
development projects, sustaining existing product families, or
system/services support. This is a hybrid position based out of
Marlborough, MA with the expectation to be in the office a minimum
of two days per week. Your Responsibilities Will Include: Working
knowledge of Design Controls. Provide quality and compliance input
to project teams for project decisions and deliverables (i.e.
Design Change Analysis, Design Inputs, Design Outputs, Test
Methods, Design Reviews, Design V&V, Usability Testing, SW
Validation, Process Validation and Labeling). Creation and review
of Risk Management documentation such as Hazard Analysis, Task
Analysis, Design Failure Mode, and Effects Analysis (DFMEA) and
Fault Tree Analysis (FTA). Understand and support linkage of field
data and Risk Management Apply sound, systematic problem-solving
methodologies in identifying, prioritizing, communicating, and
resolving quality issues (i.e. 5 Whys analysis, Is-Is Not analysis,
DMAIC problem solving methodologies). Provide quality guidance to
assure country specific compliance. Champion compliance to company
policies, work instructions and SOPs. Fully conversant with
validation techniques and associated regulatory requirements
including analysis of customer feedback and complaints. Support
effective quality assurance, process controls and metrics using
data and statistical analysis to drive improvements and actions for
manufacturing and assembly of products. Provide quality and
compliance input for post market product sustaining activities,
such as design changes, supplier auditing and surveillance, design
concessions, product CE marking and safety certification, customer
complaint investigations, NCEP's, CAPA's PIRs, Field Signals
Evaluations and Field Actions. Support internal and external
regulatory audits as required. Support collection and analysis of
key quality trending information and data for Management Review and
Complaint Reviews. Required Qualifications: Bachelor's Degree in
Mechanical, Electrical, Biomedical Engineering, or related degree.
Minimum of 5 years of Medical Device engineering experience with a
Bachelor's Degree OR a minimum of 3 years Medical Device
engineering experience with a Master's Degree. Working knowledge of
the FDA, ISO, EUMDR and the medical device industry quality
requirements associated with product development, design controls,
product risk management, and usability engineering. Travel
approximately 10-25% Preferred Qualifications: Strong communication
(oral and written) and presentation skills. Ability to collaborate
and work on a global team. Previous Experience in integrations.
Focus on detailed work with emphasis on accuracy and completeness.
Excellent organizational and planning skills; drives for results.
High energy problem solver capable of driving items to closure.
Minitab Statistical Analysis software (or equivalent). Requisition
ID: 581181 Among other requirements, Boston Scientific maintains
specific prohibited substance testing requirements for
safety-sensitive positions. This role is deemed safety-sensitive
and, as such, candidates will be subject to a drug test as a
pre-employment requirement. The goal of the drug testing is to
increase workplace safety in compliance with the applicable law. As
a leader in medical science for more than 40 years, we are
committed to solving the challenges that matter most - united by a
deep caring for human life. Our mission to advance science for life
is about transforming lives through innovative medical solutions
that improve patient lives, create value for our customers, and
support our employees and the communities in which we operate. Now
more than ever, we have a responsibility to apply those values to
everything we do - as a global business and as a global corporate
citizen. So, choosing a career with Boston Scientific (NYSE: BSX)
isn't just business, it's personal. And if you're a natural
problem-solver with the imagination, determination, and spirit to
make a meaningful difference to people worldwide, we encourage you
to apply and look forward to connecting with you! At Boston
Scientific, we recognize that nurturing a diverse and inclusive
workplace helps us be more innovative and it is important in our
work of advancing science for life and improving patient health.
That is why we stand for inclusion, equality, and opportunity for
all. By embracing the richness of our unique backgrounds and
perspectives, we create a better, more rewarding place for our
employees to work and reflect the patients, customers, and
communities we serve. Boston Scientific is proud to be an equal
opportunity and affirmative action employer. Boston Scientific
maintains a prohibited substance free workplace. Pursuant to Va.
Code - 2.2-4312 (2000), Boston Scientific is providing notification
that the unlawful manufacture, sale, distribution, dispensation,
possession, or use of a controlled substance or marijuana is
prohibited in the workplace and that violations will result in
disciplinary action up to and including termination. Please be
advised that certain US based positions, including without
limitation field sales and service positions that call on hospitals
and/or health care centers, require acceptable proof of COVID-19
vaccination status. Candidates will be notified during the
interview and selection process if the role(s) for which they have
applied require proof of vaccination as a condition of employment.
Boston Scientific continues to evaluate its policies and protocols
regarding the COVID-19 vaccine and will comply with all applicable
state and federal law and healthcare credentialing requirements. As
employees of the Company, you will be expected to meet the ongoing
requirements for your roles, including any new requirements, should
the Company's policies or protocols change with regard to COVID-19
vaccination.
Keywords: Boston Scientific, Haverhill , Senior Design Quality Assurance Engineer - Integrations, Engineering , Marlborough, Massachusetts
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