Key skills
LeadershipProject ManagementRisk ManagementCommunicationNegotiation
About this role
Role Overview
- 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.
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
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days