Senior MedTech Product Engineer — End-to-End R&D

B. Braun Melsungen AG

Allentown (Lehigh County)

On-site

USD 95,000 - 105,000

Full time

7 days ago
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Benefits offered by this job

Healthcare
401(k) plan
Tuition reimbursement

Job summary

B. Braun Medical Inc. in Allentown, PA is seeking a Product Engineer for our R&D team to lead full lifecycle development of medical devices.

You will work with customers to define requirements and ensure compliant, high-quality solutions under FDA 21 CFR Part 820, ISO 13485 and ISO 14971. The ideal candidate has a B.S. in Engineering and 6–8 years of experience in a regulated environment, with CAD proficiency (SolidWorks preferred) and strong project leadership, capable of delivering reliable

Qualifications

  • Bachelor's degree required.
  • 6+ years of related experience in engineering and regulated environments.
  • Regular and predictable attendance.
  • Applicable industry/professional certification preferred.

Responsibilities

  • Develops, evaluates and improves industrial manufacturing methods with design, materials, and tooling knowledge.
  • Analyzes and plans workforce utilization, space requirements, and equipment layout for efficiency.
  • Estimates production times, staffing needs and related costs for management decisions.
  • Communicates manufacturing capabilities and schedules to facilitate production processes.
  • Confers with vendors to determine specifications and procure equipment and parts.
  • Evaluates products based on specifications and quality standards.

Skills

Project leadership
CAD proficiency
Regulatory understanding
Communication

Education

Bachelor's degree

Tools

SolidWorks

Job description

B. Braun Medical Inc. in Allentown, PA is seeking a Product Engineer for our R&D team to lead full lifecycle development of medical devices.

You will work with customers to define requirements and ensure compliant, high-quality solutions under FDA 21 CFR Part 820, ISO 13485 and ISO 14971. The ideal candidate has a B.S. in Engineering and 6–8 years of experience in a regulated environment, with CAD proficiency (SolidWorks preferred) and strong project leadership, capable of delivering reliable

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