Device Development Associate Principal Scientist – Development Strategy – Design Controls – Associate Director Equivalent

Device Development Associate Principal Scientist – Development Strategy – Design Controls – Associate Director Equivalent

Requirements

• B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus 10 years of related experience
• Has broad knowledge of medical device development, design controls and risk management
• Led and managed development of DHF (design history file) deliverables for medical devices
• Recognized as a subject matter expert in at least one medical device development or design controls area
• Knowledge of U.S. and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.
• Proven track record of applying analytical skills in product design, development, and evaluation
• Self-motivated and work independently
• Proven ability to work with team members of diverse skill sets and backgrounds
• Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership
• Excellent communication, presentation, negotiation, project management, and organizational skills
• Willing to travel
• Able to quickly pick up advanced domain knowledge
• Able to multi-task continuously

Responsibilities

• Lead/contribute to device development, design controls for the assigned projects.
• Lead the implementation and/or ensure effective execution of the device development strategy and design controls for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication to cross-functional stakeholders, including external suppliers.
• Proactively resolve project obstacles and challenges and communicate device development strategy and design controls approach within Device Development and with external suppliers.
• Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.
• Lead the preparation of materials for program presentations for management review and regulatory submission.
• Contribute to the development, implementation, and continuous improvement of design controls processes, procedures, and tools.
• Enhance our Company’s professional image and competitive advantage through publications, presentations, patents, and professional activities.
• Stay current with relevant regulations, technologies, standards, and effectively share this knowledge with others.

Preferred Qualifications

• Master’s degree in one of the above disciplines plus 7 years related experience OR a PhD in one of the above disciplines plus 5 years related experience
• Experience with the development drug-device combination product or a medical device component of a combination product
• Experience with leading development projects at an enterprise level
• Experience with device design, requirement management, FMEA, design verification, design validation, statistical sampling, and control strategy
• Experience with regulatory fillings
• Working knowledge of ISO 11608 and ISO 11040