Reporting to the Director, Quality, this position will plan and ensure the implementation of the ISO 14971, IEC 62366 and 21 CFR 820 standards to ensure safe products exceed customer and market requirements. This individual will need to work closely with manufacturing sites, support audits, work with new product development, as well as on-market teams in regard to change management and product life-cycle management.
The Senior Manager, Risk Management will ensure product development utilizes appropriate engineering and scientific analyses during the product development and commercialization process for medical device and combination products. In addition, conduct analysis and investigation of product or quality system issues intended to support the continuous improvement surrounding the quality of products and systems.
KEY DUTIES AND RESPONSIBILITIES:
1. Develop and maintain Risk Management Files according to ISO 14971 and ensure Risk Management Files are updated per defined schedules and frequencies. This would include risk management plans, hazard analyses, user risk assessments, design risk assessments and process risk assessments. Provide Risk Management technical expertise through the product life cycle and drive the concept of Systems Risk Analysis across the organization.
2. Work with all production and post-production functions (manufacturing, post market surveillance, complaints, CAPA, Corrections and Removals, Change Control, Supplier Quality, acceptance activities) to ensure the proper application, use and updates of risk management files.
3. Support the Risk Management and Safety Management Team Review process to ensure all activities are completed to maintain the risk management file as new information is learned during the product development process or per signals obtained through post market surveillance programs.
4. Work with R&D, Medical Safety, CMC, Clinical Development on the development and incorporation of Risk Management during all design phases for new and/or product enhancements. Facilitate development and completion of risk assessments. Work cross-functionally with personnel and support the ongoing maintenance of appropriate harm/hazard analysis for issues potentially impacting patient outcomes.
5. Keep up to date on new regulations and standards that affect Risk Management for medical devices. Ensure Risk Management procedures, processes and files are updated where required. Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross function teams. Participate in regulatory inspection and notified body audits.
6. Develop and maintain effective relationships and integration activities with other departments.
Education and Experience:
1. Bachelor’s degree in engineering, physical or life sciences with a minimum of 7-10 years’ experience in the medical device quality engineering for new product development and sustaining product engineering.
2. Proven experience working with medical device companies’ Risk Management, Design Control and Human Factors Usability Engineering programs and/or processes.
3. Experience with problem solving/risk assessment.
4. Proven ability to generate results.
Essential Skills and Abilities:
1. Excellent written and verbal communication skills.
2. Experience reading drawings, shop orders, and documentation.
3. Computer literate; use of word processing, spreadsheets.
4. Experience with statistical and six sigma methods required, and Black Belt
5. Experience with risk management processes and tools
6. Experience with sustaining engineering
7. Experience with Class II or III medical devices required, and experience with implantable devices preferred
8. Experience working with external contract partners for design, development, manufacturing, and/or testing
9. Extensive knowledge of US and International Design Control, Producte Development, Quality System and Risk Management requirements (specifically 21 CFR Parts 4, 803, 806, & 820, MDD, CMDR, ISO 13485, ISO 14971, EN 60601, IEC 62366 ), as well as other applicable standards (e.g., AAMI, ANSI) required
10. Critical Thinking and Problem Solving.
11. Ability to recognize problems and take corrective measures.