Engineer Manager- Design Control

Medtronic
Posted

Post Expires

Type

Junior industry position

Position Description:
Engineer Manager- Design Control, Covidien LP (a Medtronic company), Irvine, CA. Engineering Manager – Design Control provides engineering support for technologies used to treat brain aneurysms, arteriovenous malformations, and other vascular lesions. Understands endovascular procedures and applies knowledge to product development and product risk assessment. Applies understanding of human biology and physiology and application of biomedical engineering. Provides design control expertise to new product development teams. Lead projects related to major design control upgrades utilizing application tools.  Utilizes application tools to include computer aided design (CAD), Minitab and Microsoft Project and Vizio. Utilizes engineering principles including biomedical materials, strength of materials, components and engineering drawing.  Navigates the complexities of various government and agency regulations to include FDA & QSR requirements and guidance including 21 CFR820, ISO13485 and ISO14971. Leads CAPA (Corrective and Preventative Actions) projects for existing product lines. Utilizes process validations including installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ). Understand and employ’s Design for Six Sigma tool (DFSS) Kaizen, DMAIC or DMADV. Provides statistical applications and tools including hypothesis testing, distribution identification analysis, data transformations, tolerance interval analysis (confidence and reliability analysis), control charts (SPC), measurement system analysis (gage studies), process capability and sample size determination. 

 

Basic Qualifications:
Master’s degree in Mechanical, Materials, or Biomedical Engineering or related science field and 2 years of experience in medical device engineering; OR a Bachelor’s degree in Mechanical, Materials, or Biomedical Engineering or related science field and five years of experience in medical device engineering. Must possess a minimum of 2 years of experience with each of the following:  application of human biology and physiology to biomedical engineering; application tools to include computer aided design (CAD), Minitab and Microsoft Project and Vizio; engineering principles including biomedical materials, strength of materials, components and engineering drawing; FDA & QSR requirements and guidance including 21 CFR820, ISO13485 and ISO14971; leading CAPA projects; process validations – installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ); Design for Six Sigma tool (DFSS) Kaizen, DMAIC or DMADV; and statistical applications and tools such as data transformations, tolerance interval analysis (confidence and reliability analysis), or process capability and sample size determination.

More Information

Posted

Post Expires

Type

Junior industry position

Irvine%2C%20United%20States

Irvine , United States