Quality Engineer II, Design Assurance - Allentown, PA, United States - B. Braun Medical Inc

Description

Braun Medical, Inc.
Braun Medical, Inc.
Quality Engineer II, Design Assurance

Type:
Hybrid Full Time

# Category:
Quality

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.

Braun Medical is headquartered in Bethlehem, Pa., Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs.

Braun Medical, visit
Responsible for working as the Quality Assurance member on new product development projects for the B. Braun Medical Inc medical device franchise. The desired candidate will have experience with design controls and the associated regulations related to medical devices.

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.

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 through.

Responsible for data trending and analysis, issue identification and resolution.
Prepares reports for key quality metrics and lead continuous improvement efforts in Quality.
Operates in accordance with company policies, procedures and regulatory requirements (FDA, ISO, MDD, CMDR, etc.).
Provide Design Controls support related to new product development, product design modifications and transfer to manufacturing.

Ensure appropriate application of company policies and procedures related to medical device development - Design Controls, Risk Management, Test Method Development, and Statistical Data Analysis.

Maintain oversight of cGMP documentation, including, but not limited to Design History Files, Device Master Record, Device History Records, Change Control and Technology Transfer.

Operate in accordance with company policies, procedures and regulatory requirements (FDA, ISO, MDD, MDR, CMDR).
Requires advanced knowledge of professional field and industry.
Influences the development of and drives the application of principles, theories, concepts.
Work under minimal supervision.
May periodically assist in orienting, training, and/or reviewing the work of peers.
Occasional contact with external contractors/vendors.
#Target Based Range
$Qualifications -Education/Experience/Training/Etc
Bachelor's degree required or equivalent combination of education and experience.
Occasional business travel required

Frequently:
Sit, Visual Acuity with or without corrective lenses

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
Proximity to moving parts
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


Constantly:
Office environment

Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. Equal Opportunity Employer Veterans/Disabled

All 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.