What are the responsibilities and job description for the Design Control Risk Management position at Wise Skulls llc?
Job Title : Design Control Risk Management
Location : Rahway, NJ (Onsite)
Duration : 12 Months
Implementation Partner : Kaleidoscope Innovation
End Client : To be disclosed
Principal 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 relative to design controls and risk management activities.
Position Qualifications :
Education Minimum Requirement :
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.
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
Preferred Experience and Skills :
Experience with the inhalation products (such as Dry-power inhaler), combination product 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
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