Device Development Associate Principal Scientist (Associate Director Equivalent) – Development Strategy, Design Controls and Risk Management

Job Description

Position Description:

Device Development Associate Principal Scientist – Development Strategy, Design Controls and Risk Management

Our company’s Device Development (DD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action.  The DD Team manages the development of the device constituent of our company’s pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection.

This position will be responsible for leading and implementing medical device and combination product design controls and risk management activities 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, design control principles and risk management techniques 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 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.

• 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 and risk management 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

Position Qualifications:

Education Minimum Requirement:

• B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering,  or other types of engineering plus 10 years of related experience

Required Experience and Skills:

• 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 and risk management 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 Experience and Skills:

• 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 deve