Project Engineer Medical Products.

Project Engineer in Medical Products

Our client is an international, innovative company specializing in wound healing solutions and products. 

Location: Full-time (3/2 Home Office)
Workload: 100%
Your Role: Working as Project Engineer within the Supply Chain & Quality department your responsibilities will include:

• Prepare design options for product realization and develop working models and prototype

• Identify performance, cost, quality, and timing trade-offs and implement corrective actions

• Document product and performance requirements for product development, and future technical use; conforming to ISO, FDA, MDR, MDD and other regulatory standards

• Provide support to Sourcing, Procurement, Marketing and Quality

• Manage and support outsourced machine, fixture, and tool fabrication 

• Support the Non-Conforming Report (NCR) process through reviews and disposition approvals.

• Perform as a project resource on assigned projects

Qualifications:

• Bachelor of Science (BS) degree in Engineering or related field required

• Minimum seven years’ experience in engineering required

• Mechanical design, materials, analysis, and manufacturing experience required

• Plastic part design, materials, analysis, and manufacture direct experience strongly preferred

• Electro-mechanical design, analysis and manufacturing experience strongly preferred

• Knowledge of Sterilization and Biocompatibility medical process preferred 

• Medical product or regulated environment experience strongly preferred

• ASQ certifications is a plus

• Knowledge of ISO 13485, FDA 21 CFR 820, and GMP required

• Six Sigma Certification is preferred.

• Must be able to read, understand and communicate in English and German

Physical demands

• Travel up to 30% of the time, including occasional international travel

• Must be able to occasionally lift and/or move up to 50 pounds

How to Apply:

Submit your application here, your detailed CV is enough. We look forward to hearing from you!