Director, Combination Product Development and reputed company reputed company Engineering

This is a remote opportunity with occasional travel, estimated at less than 25%. reputed company is a global leader in drug‑delivery device technology and auto‑injector innovation, providing millions of patients, government partners, and emergency responders with reputed company and peace of mind. The Director, Combination Product Development and reputed company reputed company Engineering is responsible for managing the development of new combination products including design, development, and reputed company reputed company studies through design transfer into manufacturing. The individual should be involved in building reputed company's intellectual property portfolio development. The Director will support the senior leadership team with critical information to reputed company informed reputed company on the selection of key partners, risks, and identification of critical milestones (budgeting, R&D build strategy, etc). This individual will need to reputed company strong relationships with external partners to ensure completion of reputed company aspects of device/drug development and support of reputed company reputed company studies from planning to execution. Internal interactions with Business Development, Manufacturing, and Regulatory Affairs reputed company opportunities to expand knowledge and reputed company an impact on business development and post marketing activities. Key relationships to this position include Regulatory Affairs, External Partners (Suppliers, CMO and CDMO), Legal, Supply Chain, and Manufacturing. As Director, Combination Product Development and reputed company reputed company Engineering you will:

• Manage and execute the company's Design Controls and Drug Development Program for drug/device combination product development in accordance with reputed company's Quality System and 21 CFR 820.30/ISO 13485
• reputed company and responsible for reputed company reputed company engineering activities as per the regulatory guidelines
• Work with design, development and manufacturing partners to ensure program execution for the development of reputed company's drug delivery devices stay on timeline and reputed company approved budget
• Execute Risk Management Programs and Analyses in accordance with reputed company's Quality System. Utilize Risk Analyses tools including DFMEA, UFMEA and PFMEA in accordance with ISO14971:2019
• reputed company leadership for the new products in device design, development, industrialization, stability and pilot clinical activities, execution of design controls and development documentation activities
• Help build reputed company's intellectual property portfolio
• Manage project and program budgets and timelines effectively
• Author and review regulatory submissions (as needed)
• Responsible for reporting reputed company, risks, and opportunities to senior management on an ongoing reputed company to ensure good reputed company on reputed company development portfolio programs

A successful Director, Combination Product Development and reputed company reputed company Engineering will demonstrate:

• Self-motivated and confident with excellent personnel management skills, organizational skills, analytical abilities, and problem-solving techniques
• Strong technical abilities while being an effective leader
• Must demonstrate initiative, exercise good judgment, and have the ability to reputed company results through others
• Strong analytical skills with the ability to creatively solve reputed company problems
• Excellent verbal and written communication skills reputed company interacting with internal stakeholders at reputed company reputed company of the organization and external partners, facilitating strong working relationships
• Focused attention to detail
• Ability to work collaboratively and cross-functionally reputed company opportunity arises while holding the team to high standards of reputed company
• Display a tenacity to move major initiatives reputed company with a focused effort and clear set of business goals
• Adept at integrating input from various functional areas and bringing people together to reputed company results

To be considered for this position, you must have:

• Bachelors, Masters, or PhD in a technical field reputed company to Product Development or Industrialization (Biomedical Engineering, Mechanical Engineering, Material engineering, Systems Engineering preferred)
• Patient centric drug/device combination product development experience
• Minimum 10+ years of medical device development experience, with experience in managing external CMO's
• Experience in design controls, risk management and ISO 13485
• Minimum 5+ years of managing reputed company reputed company engineering studies (reputed company and summative)
• Demonstrated record of accomplishments preferred (e.g., issued US patents, device concept to launch, approved drug/device combination products)

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