Staff Engineer, Design Assurance

Position Summary In this role, the Staff Engineer Design Assurance will be responsible for design control activities. You will execute design control activities and work with multiple engineering teams through the various design control phases. This includes experience and knowledge in Design Inputs, Design Trace, Verification, Validation, Biocompatibility Sterilization Validation, Data Analysis, Design Transfer, Design Change and Design History Files. Responsibilities and Duties Contribute to New Product Development Ensure compliance with risk management, quality and design control requirements is demonstrated in design and development projects. Supports, plans, and executes initiatives that support best practices. Contributes in sub-project workstreams as required to support projects. Prepare, conduct, and support routine meetings to ensure accountability and milestone achievements with cross-functional teams as needed. Set prioritization of activities and follow-up on actions. Actively seeks collaboration and builds relationships with internal customers. Proactively identify and follow up on risks and improvements and accelerate issues in a timely manner. Leads problem solving activities and identifies root cause to issues. Support internal and external audits as a subject matter expert for Design Assurance. Other essential duties as directed. Requirements Bachelor of Science degree in engineering or technical discipline. Minimum 8 plus years of related experience, preferably in the medical device industry related to operations/design/quality engineering. Experience with Class II and Class III Medical Device Product Development. Experience in Design Control, Design Verification, Design Validation, Statistical Data Analysis, Sterilization Validation, Biocompatibility Testing, Design Change Management, and Design Transfer. Demonstrated expertise in root cause analysis tools such as fishbone diagram, Ishikawa diagram, fault tree, etc. Knowledge of EU 2017/745 (EU MDR), FDA QSR, ISO 13485, ISO 14971, Electrical Safety Standards, Electromagnetic Compatibility Standards, Software Development Standards, and other applicable industry standards. Proven planning and organizational skills with background and experience in project management principles, practices, techniques, and tools. Strong analytical skills and the ability to operate effectively in a team environment. Ability to analyze complex problems, interpret operational needs, and develop integrated, creative solutions. Must be able to work independently, self-motivated, a sense of ownership with a strong sense of urgency to drive for results. Responds well under pressure and manages stress. Effective at dealing with change and ambiguity as business needs shift, demonstrating flexibility while ensuring compliance. Ability to gain cooperation and commitment from people through influence. Excellent verbal and written communication skills and comfortable presenting to small and large groups. Expert in Excel, Power Point, Visio, and Word. Experience in working with global teams. Salary Range: $156,000 - $170,422 (Annual base Salary). Equal Employment Opportunity At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. #J-18808-Ljbffr Otsuka Pharmaceutical Co., Ltd