Senior Design Assurance Engineer - Med Device Quality DHF

Cypress HCM; Maple Grove (MN); On-site; USD 100,000 - 130,000; Full time

Job summary

Cypress HCM is looking for a Senior Design Assurance Engineer in Maple Grove, Minnesota. This role involves ensuring quality input and deliverables for new product development in medical devices. Candidates should have over 5 years of experience in medical device development and possess strong knowledge of quality systems and risk management practices. The position offers a competitive salary of $100,000 - $130,000 plus a 15% bonus.

Qualifications

• 5+ years of experience in medical device development.
• 3+ years of experience in Design Assurance or Quality Engineering.
• Understanding of ISO 14971 and risk management applications.

Responsibilities

• Plan and execute Hazard Analysis and FMEA/Risk Assessments per ISO 14971.
• Draft and approve product development deliverables.
• Manage product Design History Files.

Skills

Medical device development

Design Assurance or Quality Engineering

Risk management knowledge

Quality tools usage

Statistical software (Minitab)

Job description

Cypress HCM is looking for a Senior Design Assurance Engineer in Maple Grove, Minnesota. This role involves ensuring quality input and deliverables for new product development in medical devices. Candidates should have over 5 years of experience in medical device development and possess strong knowledge of quality systems and risk management practices. The position offers a competitive salary of $100,000 - $130,000 plus a 15% bonus.