Job Description

• Lead/contribute to device development, design controls and risk management strategy for the assigned projects.
• Lead the implementation and/or ensure effective execution of the device development strategy, design controls and risk management activities 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, design controls and risk management approaches within Device Development and with external suppliers.
• Understand and apply regulatory / compliance requirements related to design controls and risk management activities.
• 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.

• B.A./B.S. in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus 5 years of related experience.
• Previous experience in inhalation drug delivery.
• 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.
• 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.
• Self-motivated and work independently.
• Experience with the inhalation products (such as Dry-power inhaler), combination products or a medical device component of a combination product.
• Master's degree in one of the above disciplines plus 3 years related experience.
• Experience with device design, requirement management, FMEA, design verification, design validation, statistical sampling, and control strategy has context menu.

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