Sr. Design Assurance Engineer

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

Position Summary:

This position provides leadership, and guidance on all Design Controls and Risk Management activities related to the development of new products with embedded and standalone software. It requires subject matter expertise in the applicability of the IEC 62304, IEC 60601, IEC 62366, ISO 14971 standards, and Cybersecurity Requirements for Medical Devices.

Responsibilities:
Essential Duties

• 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 identification and
• 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 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.

Expertise:
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.

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,…