Design Control Risk Management
Design Control Risk Management
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Location: Rahway NJ (Onsite)
Duration: 12 Months
Implementation Partner: Kaleidoscope Innovation
End Client: To be disclosed
- 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 managementapproved strategic plans corporate policies and providing clear communication to crossfunctional 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 relative to design controls and risk management activities.
- B.A./B.S in Mechanical Engineering Biomedical Engineering Industrial and System Engineering or other types of engineering plus 5 years of related experience
- Required Experience and Skills:
- 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.
- Selfmotivated 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
- Experience with the inhalation products (such as Drypower inhaler) combination product or a medical device component of a combination product
- Masters 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
Employment Type
Full Time
