Sr Design Assurance Engineer - Active Medical Device
Company: B. Braun Medical
Location: Allentown
Posted on: May 16, 2022
Job Description:
B. Braun Medical, Inc.Sr Design Assurance Engineer - Active
Medical DeviceUS-PA-Allentown - US-PA-AllentownJob ID:
2021-19241Type: Regular Full-Time# of Openings: 1Category:
QualityCorp at Allentown AuxiliaryOverviewAbout B. Braun B. Braun
Medical Inc., a leader in infusion therapy and pain management,
develops, manufactures, and markets innovative medical products and
services to the healthcare industry. Other key product areas
include nutrition, pharmacy admixture and compounding, ostomy and
wound care, and dialysis. The company is committed to eliminating
preventable treatment errors and enhancing patient, clinician and
environmental safety. B. Braun Medical is headquartered in
Bethlehem, Pa., and is part of the B. Braun Group of Companies in
the U.S., which includes B. Braun Interventional Systems, Aesculap
- and CAPS -. Globally, the B. Braun Group of Companies employs
more than 64,000 employees in 64 countries. Guided by its Sharing
Expertise - philosophy, B. Braun continuously exchanges knowledge
with customers, partners and clinicians to address the critical
issues of improving care and lowering costs. To learn more about B.
Braun Medical, visit .ResponsibilitiesPosition Summary:Responsible
for working as the Quality Assurance member on new product
development projects for the B. Braun Medical Inc active medical
device franchise. The desired candidate will have experience with
design controls specially related to active medical devices and
associated software development processes. The position will also
be responsible for working with external specification developers
and contract manufacturers as part of new product development and
product life cycle management that includes design changes. The
ability to work in a cross functional team and ensure compliant
project execution is a must. Responsibilities: Essential Duties
- Provides Design Assurance Quality Engineering support, to the
R&D and Sustaining Engineering organization for new products,
product design modifications, and OEM customers; this includes
creation of Quality and Validation plans, risk analysis,
traceability matrixes, URS/FS, Design Reviews, customer interface,
and follow
- Ensure appropriateness application of company policies and
procedures for medical device design controls, risk management,
test method development, statistical data analysis, and support of
regulatory filings.
- Maintain oversight of cGMP documentation, including, but not
limited to design history files, regulatory submissions, device
history records, change control, validations, methods, and
technology transfer.
- Ensure documents are thorough, accurate and compliant to
support regulatory inspections and
- Operates in accordance with company policies, procedures and
regulatory requirements (FDA, ISO, MDD, CMDR, ).
- Defines implements and monitors metrics for key Prepare and
present trend reports to management, as applicable.
- Proactively investigates, identifies and implements improved
quality practices and drives continuous improvement efforts through
facilitating, leading, and collaborating with cross function
- Prepares reports for key quality metrics and lead continuous
improvement efforts in Quality.The job function listed is not
exhaustive and shall also include any responsibilities as assigned
by the Supervisor from time to time. General: It shall be the duty
of every employee while at work to take reasonable care for safety
and health of himself/herself and other persons. Expertise:
Knowledge & Skills
- Please refer to the Corporate Guidelines or BBMUS Guidelines or
job specific authorities where applicable. This list is however not
exhaustive and may be amended by the Management from time to
time.
- Requires advanced knowledge of professional field and industry.
Influences the development of and drives the application of
principles, theories, concepts. Determines best course of
action.
- Work under minimal supervision. Relies on experience and
judgement to plan and accomplish assigned goals. May periodically
assist in orienting, training, and/or reviewing the work of
peers.
- Judgement is required in resolving all day-to-day
problems.
- Contacts are primarily with department supervisors, leads,
subordinates, and peers. Occasional contact with external
contractors/vendors.QualificationsExpertise: Qualifications
-Education/Experience/Training/Etc Required:
- Bachelor's degree required or equivalent combination of
education and experience.
- 06-08 years related experience required.
- Occasional business travel required
- Regular and predictable attendance While performing the duties
of this job, the employee is regularly required to sit and talk or
hear. The employee frequently is required to use hands to handle or
feel and reach with hands and arms. The employee is occasionally
required to stand and walk. The employee must occasionally lift
and/or move up to 20 pounds. Additional Information
Responsibilities: Other Duties: The preceding functions have been
provided as examples of the types of work performed by employees
assigned to this position. To perform this job successfully, an
individual must be able to perform each essential duty
satisfactorily. The requirements listed in this description are
representative of the knowledge, skill, and/or ability required.
Management reserves the right to add, modify, change or rescind the
work assignments of different positions due to reasonable
accommodation or other reasons. Physical Demands:While performing
the duties of this job, the employee is expected to:
- Light work - Exerting up to 20 lbs of force occasionally,
and/or up to 10 pounds of force frequently, and/or a negligible
amount of force constantly to move objects.Lifting, Carrying,
Pushing, Pulling and Reaching:
- Occasionally: Reaching upward and downward, Push/pull,
Stand
- Frequently: Sit, Visual Acuity with or without corrective
lenses
- Constantly:N/AActivities:
- Occasionally: Climbing stairs/ladders, Handling, Push/pull,
Reaching upward and downward, Standing, Walking
- Frequently: Finger feeling, Hearing - ordinary, fine
distinction, loud (hearing protection required), Seeing - depth
perception, color vision, field of vision/peripheral, Sitting ,
Talking - ordinary, loud/quick
- Constantly: N/AEnvironmental Conditions:
- Occasionally: Proximity to moving parts
- Frequently: N/A
- Constantly: N/A Work Environment: The work environment
characteristics described here are representative of those an
employee encounters while performing the essential functions of
this job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
- Noise Intensity: Moderate
- Occasionally: Production/manufacturing environment, Lab
environment
- Frequently: N/A
- Constantly: Office environment What We OfferB. Braun offers an
excellent benefits package, which includes healthcare, a 401(k)
plan, and tuition reimbursement. To learn more about B. Braun and
our safety healthcare products or view a listing of our employment
opportunities, please visit us on the internet at
www.bbraunusa.com.
Through its Sharing Expertise - initiative, B. Braun promotes best
practices for continuous improvement of healthcare products and
services.NoticesEqual Opportunity Employer Veterans/DisabledAll
qualified applicants will receive consideration for employment
without regard to race, color, sex, sexual orientation, gender
identity, religion, national origin, disability, veteran status,
age, marital status, pregnancy, genetic information, or other
legally protected status.PI177339124
Keywords: B. Braun Medical, Allentown , Sr Design Assurance Engineer - Active Medical Device, Engineering , Allentown, Pennsylvania
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