Sr Risk Management Engineer
PURPOSE AND SCOPE:
The Sr. Engineer possesses specific product lines knowledge to be a resource and key technical expert to support related projects. The Sr. Engineer is largely unsupervised and self-motivated to lead projects. Shall be capable of being given high level tasks and working independently to organize work, from required Cross Functional Teams (CFT) and to produce the final product or outcome assigned. The Sr. Engineer is expected to be trusted to provide production support to ensure product reliability, dependability and efficient manufacturability. The Sr. Engineer is also capable of formulating new research projects - from starting with a concept, formulating a pre-development plan and completing a feasibility study. The Sr. Engineer can act as the expert in a cross technical team (CTT) to execute a project and/or solve hard to diagnose problems. The Sr. Engineer, as a technical expert, may be called upon to provide system related technical seminars across the company.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Owner and subject matter expert for all risk management deliverables where R&D/Design Owner is responsible per company policies and procedures.
- Risk management file owner for North America product portfolio.
- Supports design related risk topics globally for product portfolio.
- Develops and leads all aspects of the design FMEAs, product Risk or Hazard Analysis and other risk assessment processes and documentation (as required). Ensures action outputs are captured in project planning.
- Ensures risk management files are in alignment with company policies and procedures and risk management requirements of ISO 14971.
- Creates and maintains all product risk documentation throughout product lifecycle. Maintains risk management file for regulatory submissions and audits.
- Authors and facilitates design related risk assessments or risk reviews.
- Leads or provides input for periodic risk reviews.
- Ensures risks for products within portfolio are updated at the system level and alignment of risk evaluations between interfacing products. Point of contact for system level risk management activities.
- Migrates legacy documentation into electronic format using global systems (PTC Windchill, Polarion, ThingWorx, etc.).
- Ensures alignment between design FMEA, process FMEA and product Risk or Hazard Analysis.
- Collaborates with the manufacturing sites related to process risks and controls.
- Point of contact for risk based decisions on the product (i.e. disposition of anomaly reports, quality events in production, complaints, design related CAPAs and NCs, etc.) including providing guidance and direction on methods, tools, and techniques for obtaining solutions.
- Coordinates with all needed functional roles (i.e. medical/clinical, complaints, post market surveillance, etc.) to develop/maintain risk documentation.
- Works with product owners to develop and maintain a profile for product portfolio risks (i.e. single sourced suppliers, obsolescence, regulation changes, manufacturing capacity constraints, manufacturing capability). Works with cross-functional team to reduce identified risks.
- Provides risk management direction, training and guidance to others.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EXPERIENCE AND REQUIRED SKILLS:
- Bachelor's Degree in related engineering or scientific discipline required; Advanced Degree desirable
- Minimum 5 – 8 years’ related risk management experience.
- Experience with medical device risk management.
- Experience in planning Risk Management activities for a complex project.
- Experience with common Risk Management tools (Risk Analysis, FMEA, etc.).
- Effective utilization of Risk Management processes and tools to support development and risk based decisions through product lifecycle.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.