Scientific and Clinical Careers

Job Title

Scientific & Clinical Job Details

Biomedical Engineer

Job Code: #689
Job Type: Contract
Salary: $30.00 - $35.00/hour
Job Location: Franksville, WI
Posted yesterday

Job Description

Title:  Biomedical Engineer

Pay:  $30.00 - $35.00/hour

Job Overview:  Support aspects of project work related new medical device commercialization, sustaining engineering, manufacturing process development, qualification, and validation.  Responsibility for budget and schedule as well as Design Controls documentation.  Support aspects of project work related new medical device commercialization, sustaining engineering, manufacturing process development, qualification, and validation.  Responsibility for budget and schedule as well as Design Controls documentation.  

Installed Base Support

  • Provide continuing product support for manufacturing, regulatory and quality on design requirements, customer needs, testing, CAPA, reliability predictions, and product documentation.

Product Design Support – Serviceability

  • Create and implement test plans, design analysis, making design adjustments, running performance calculations, and maintaining quality standards.

Supply Continuity

  • Support of the Engineering Change Order (ECO) process per Design Controls – Design Change regulations and internal policies
  • Provide continuing product support for manufacturing, regulatory and quality on design requirements, customer needs, testing, CAPA, reliability predictions, and product documentation.

Service Methods

  • Develop and implement continuous improvement against current service methodologies

Compliance

  • Ensure compliance to the requirements of ISO 13485 standards, FDA regulations and Good Manufacturing Processes regarding service and repair of new product launches and product upgrades

Requirements:

  • 3-5 years of related design and manufacturing experience in the medical device and/or component industry (Required)
  • Design Control experience including design and process verification and validation (Preferred)
  • Experience in manufacturing and assembly process development and validation (IQ, OQ, PQ and PPQ) (Preferred)
  • Minimum of 3 years’ experience in the medical device field or other Quality Control/Quality Assurance trade required.
  • Experienced in using schematic capture and PCB layout CAD software (Cadence / Allegro / Altium / Or CAD) (Preferred)
  • PCB Design and Analysis experience and understanding, grounding / EMI considerations (Preferred)
  • Familiar with project management methods and tools (Preferred)
  • Familiarity with coding (Preferred)
  • Understanding and application of ISO Quality System requirements and FDA regulations (Required)
  • Knowledge and understanding of RF circuitry (Required)
  • Familiar with a variety of manufacturing processes including mechanical and electromechanical (Required)
  • Practical knowledge of Six Sigma methodologies. Green or Black Belt certification (Preferred)