Remote Principal Quality Engineer Job in Boston, MA Medtronic

Who you are

• Bachelor’s degree
• Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
• Excellent communication and technical writing skills
• Experience in Manufacturing and/or Electro-Mechanical Medical Devices
• Leadership-level domain expertise within Engineering, R&D, or Sustaining existing technology/products
• Understanding of therapy performance, product function, and use environments
• Six-Sigma greenbelt or blackbelt certification
• Knowledge of Quality System Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC)
• Understanding of Risk Management in accordance with ISO 14971
• General understanding of Design controls in accordance with ISO 13485
• General understanding of GMP/GDP
• Familiarity with Supplier Qualification activities
• Experience with compliance audit support
• Familiarity with Statistical analysis methods.
• Proven track record in evaluating and solving complex technical problems across multiple product lines or geographies

Desirables

• Excellent communication
• Technical writing
• Manufacturing experience
• Electro-Mechanical Medical Devices
• Leadership-level domain expertise
• Understanding of Risk Management
• GMP/GDP understanding
• Supplier qualification
• Statistical analysis
• Cross-functional interaction
• Complex problem solving

What the job involves

• Support the AST GYN business for RPE Quality role.
• Evaluate product issues to ensure patient, user and security risk are assessed.
• Lead Design Quality for post-market design changes on capital hardware and disposable products.
• Collaborate with various departments to assess patient/user risk, conduct health hazard assessments, and review field data.
• Maintain risk management files throughout the product lifecycle.
• Communicate findings to Quality, Development, and Operations teams and escalate risk profile changes.
• Assure compliance to procedures, regulatory requirements and industry standards.
• Partner with clinical and commercial communities to drive product lifecycle management.
• Document and share knowledge by mentoring, coaching, and teaching employees and/or customers.