Overview
On Site
Full Time
Skills
Biomedicine
Management
Regulatory Compliance
Leadership
Communication
Presentations
Negotiations
Project Management
Organizational Skills
Mechanical Engineering
Biomedical Engineering
Systems Engineering
Design Controls
Risk Management
Health Care
Good Manufacturing Practice
Human Factors And Ergonomics
ISO 9000
Medical Devices
Requirements Management
FMEA
Job Details
Responsibilities:
- 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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