Associate Principal Scientist, Drug/Device Combo Products Full-time

Associate Principal Scientist, Drug/Device Combo Products

The Associate Principal Scientist, Drug/Device Combo Products will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.

This position will interact with cross-functional development teams within and external to Device Development. The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies. This individual will be expected to apply his/her knowledge of product development and design control principles to positively support and influence clinical and commercial combination product development and launches to ensure they are developed and manufactured in accordance with regulatory, company, and customer requirements.

Principal Responsibilities

• 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.

Qualifications

Minimum 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

Preferred requirements:

• Master's degree in one of the above disciplines plus 7 years related experience OR a PhD in one of the above disciplines plus 5 years related experience
• Experience with the development drug-device combination product or a medical device component of a combination product
• Experience with leading development projects at an enterprise level
• Experience with device design, requirement management, FMEA, design verification, design validation, statistical sampling, and control strategy
• Experience with regulatory fillings
• Working knowledge of ISO 11608 and ISO 11040

Required Skills: Accountability, Combination Products, Cross-Functional Teamwork, Design Controls, Design Failure Mode and Effect Analysis (DFMEA), Design Inputs, Design Specifications, Device Development, Injection Devices, Medical Device Quality Systems, Medical Devices, Medical Devices Design, Product Development, Project Management, Regulatory Submissions, Risk Management, Self Motivation, Stakeholder Communications, Systems Engineering

Preferred Skills: Change Management, Design Verification Testing, Leadership