Sr Quality Engineer
Medtronic
- North Haven, CT
- Permanent
- Full-time
In this exciting role as a Senior Post-Market Quality Engineer you will have responsibility for developing and implementing best practices in risk management and for providing risk management expertise throughout the product life cycle including development, market release, and post-market activities within the Robotics Surgical Technologies organization. This includes evaluating product issues to ensure patient, user and security risk are assessed, and acting as the lead Design Quality Engineer for Post-Market Design Changes on Capital Hardware.A Day in the Life
Provide comprehensive support to new product development teams with focus on supplier quality and design transfer activities.Responsibilities may include the following and other duties may be assigned.
- Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with the post market life-cycle phase.
- Conduct health hazard assessments or IIAs for fielded products.
- Conduct Corrections & Removals assessments.
- Collaborate cross functionally to perform bounding/scoping for field actions and assist in field action related regulatory inquiries.
- Assess risks that were not previously identified, as well as potential risks associated with changes in therapy, systems, products, components, manufacturing processes,
- Collaborate with Medical Safety and Complaint Handling to review and analyze field data, discuss the harm severity sources and estimate the probability or harm occurrence.
- Support Complaint trending and Severity trending signal dispositions.
- Maintain risk management file throughout product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation.
- Actively communicate findings to Quality, Development, and Operations teams and escalates when the risk profile of a medical device adversely changes.
- Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings.
- Develops, modifies, applies and maintains quality standards and protocol for risk management.
- Makes decisions and proposes solutions based on calculated risks identified through data analysis
- Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines.
- Capable of leading cross-functional projects with little or no guidance.
- Coordinate activities through the Quality Engineering Manager and report regularly on the progress of activities.
- Participate in meeting departmental goals and objectives.
- Mentor or supervise junior engineers.
- Bachelor’s degree required
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
- Bachelors degree required
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
- Working knowledge of medical device products
- Excellent communication and technical writing skills
- Experience in Manufacturing and/or Electro-Mechanical Medical Device risk assessments
- Understand therapy (clinical) performance, product function(s), and product use environments to appropriately and strategically apply technical knowledge, analysis tools and methodologies to understand and quantify residual risks.
- Six-Sigma greenbelt or blackbelt certification
- Working knowledge of Quality System Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC)
- Posting Date: May 3, 2024
- Travel: Yes,
- Salary Min: 90,000
- Salary Max: 135,000