Top 3 Must Have Skill Sets:
Experience with risk management per ISO 14971
Experience with risk analysis methods such as PrHA and FMEA for medical device or combination product
Ability to converse technically with mechanical, electronic, software, and quality engineers
Currently seeking a Sr. Engineer in our Final Products and Technology Risk Management (FPT-RM) team. In support of mission to serve patients, the FPT-RM team is a diverse team working to develop and continuously improve our drug delivery devices and combination products to ensure supply and to optimize the patient experience.
The Sr. Engineer will be responsible for development and lifecycle management of the Risk Management Files (RMF) for portfolio of combination products, as well as serving as Risk Management lead on assigned projects.
The Sr. Engineer will leverage leadership skills to actively engage with multi-functional groups to support the RMF, as well as support cross functional processes interfacing with Risk Management. This includes interfacing with the complaints and safety teams to support life cycle management.
The Sr. Engineer will support regulatory medical device reporting requirements for agencies such as FDA and European Competent Authorities, including representing FPT-RM in corresponding audits. Responsibilities will also include the continued advancement of risk assessment processes, methods and tools, and business processes for ongoing continuous improvement.
• Ensures Quality Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971 for all commercialized combination products.
• Creates and maintains the RMF’s.
• Conducts risk assessments and creates/revises risk management documents as required by Standard Operating Procedures, FDA, EU and other medical device and combination product regulations.
• Management of hazard analyses, design risk assessments, use risk assessments, system risk assessments, and process risk assessments for combination products with manual, mechanical or electromechanical device constituent parts.
• Actively collaborates with design engineers to drive design mitigations and establish effectiveness of the risk control measures
• Leads periodic and event driven risk reviews of the RMF’s for commercialized products
• Supports the complaints intake teams with assessment of risks related to reported complaints
• Supports the medical safety teams with assessment and responses to regulatory agencies and competent authorities related to medical device reporting requirements
• Successfully influences outcomes, communicates with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metrics generation and reporting
• Understands manufacturing processes for packaged and/or distributed products
• Supports root cause analysis of complaint investigations
• Doctorate degree; OR
• Master’s degree and 3 years of risk management or engineering experience; OR
• Bachelor’s degree and 5 years of risk management or engineering experience; OR
• Associate’s degree and 10 years of risk management or engineering experience; OR
• High School diploma/GED and 12 years of risk management or engineering experience
• Bachelor’s or Master’s Degree in Engineering, preferred Mechanical Engineering, Electrical Engineering, Systems Engineering, Materials Engineering, or Bio-Medical Engineering.
• 6 or more years of experience with risk analysis methods such as PrHA and FMEA for medical devices
• 5 or more years of experience in a Medical Device Development or Device Risk Management role
• 3 or more years of experience with Medical Device Reporting requirements, preferably for the European Union
• Experience with risk management per ISO 14971
• Experience is leadership role(s) and working with cross functional groups
• Experience working with complaints intake and complaints investigation teams
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Ability to converse technically with mechanical, electronic, software, and quality engineers
• Capable of managing multiple projects in a deadline driven environment
• Strong technical writing and interpersonal skills
strives to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives. In everything we do, we aim to fulfill our mission to serve patients. And every step of the way, we are guided by the values that define us.
leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
"This posting is for Contingent Worker, not an FTE"