Associate Principal Scientist, Drug/Device Combo Products

MSD•Rahway, NJ

1d•Hybrid

About The Position

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.

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
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

Nice To Haves

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
Change Management
Design Verification Testing
Leadership

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.