Sr Design Assurance Engineer
Company: B. Braun Medical
Posted on: May 16, 2022
B. Braun Medical, Inc.Sr Design Assurance
EngineerUS-PA-AllentownJob ID: 2022-20253Type: Hybrid# 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: Responsibilities: Essential
- Provides Design Assurance Quality Engineering support, to the
R&D organization for new products, 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
- Responsible for data trending and analysis, issue
- Prepares reports for key quality metrics and lead continuous
improvement efforts in
- 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.
- Drives continuous improvement efforts through facilitating,
leading, and collaborating with cross function 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
- Requires advanced knowledge of professional field and industry.
Influences the development of and drives the application of
principles, theories, concepts. Determines best course of
- 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
- Judgement is required in resolving all day-to-day
- Contacts are primarily with department supervisors, leads,
subordinates, and peers. Occasional contact with external
contractors/vendors.Additional Responsibilities: Essential Duties:
- Provide Design Assurance support related to new product
development, product design modifications and transfer to
- Provide leadership, expertise and guidance on all Design
Assurance and Risk Management activities related to the development
of new products and product improvements.
- Ensure appropriate application of company policies and
procedures related to medical device development - 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 and Technology Transfer.
- Support the continuous improvement of the quality system
elements that support the design, development, and manufacturing
transfer of new products.
- Provide support for investigations and recommend, develop and
implement effective corrective actions.
- Provide support during regulatory inspections and customer
- Identify and implement quality system improvements when gaps
are identified through audits and departmental reviews.
- Proactively investigate, identify and implement improved
quality practices and drive continuous improvement efforts through
facilitating, leading, and collaborating with cross functional
- Operate in accordance with company policies, procedures and
regulatory requirements (FDA, ISO, MDD, CMDR). Knowledge and
- Experience and knowledge of ISO 14791 and ISO
- 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,
- Frequently: Sit, Visual Acuity with or without corrective
- 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
- 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
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.PI177338917
Keywords: B. Braun Medical, Allentown , Sr Design Assurance Engineer, Other , Allentown, Pennsylvania
Didn't find what you're looking for? Search again!