Senior Engineer Medical Device and Combination Products
The Senior Medical Device and Combination Product (MDCP) engineer is a key technical leader within Global Pharmaceutical Operations (GPO). Under general direction, the engineer leverages experience gained on scientific/technical/business issues to support project teams and other technical staff in regards to design control, risk management, change control, customer complaints and deviation management for medical devices or combination products.
The person in this position participates in high impact, complex, cross-functional and cross-divisional teams and initiatives, and will provide significant leadership to achieve project goals. Effective collaboration with teams is essential to meet the company's goals/objectives. Key interfaces include sites, External manufacturing, Quality Ops, Product Development groups, Regulatory Affairs, Procurement and suppliers.
Knowledge of design control, electro mechanical systems, medical device, combination products, drug delivery, pharmaceuticals and related scientific/technical concepts and techniques are highly desirable for this position. The engineer will routinely face competing priorities, and must manage time effectively, while keeping stake-holders and team members informed with effective communication.
Actively supports and applies various initiatives and goals of our Manufacturing Division and the company; including those for design control, risk management, change control, customer complaints and deviation management.
Subject matter expert in electro mechanical devices and build capabilities for the future
Operates effectively as a leader in assigned roles on projects, or as GPO representative on multiple small teams.
Displays ownership of tasks and continuously undertakes professional development activities to improve skills.
Demonstrates the necessary inclusion skills to integrate inputs and perspectives from various sources, and communicates the decision and its Risk/Benefit implications to key stakeholders and sponsors.
Speaks/presents effectively to both internal and external audiences to influence change and build consensus.
Education Minimum Requirement:
Required: Technical BS degree or higher (MS or PhD)
Preferred: BS in Mechanical Engineering, Biomedical engineering, , electrical or electronics or computer science engineering or similar.
Required Experience and Skills:
Experience in the medical device, combination products, biologics and/or pharmaceutical industry.
Experience in design control, risk analysis, change control, customer complaints and/or deviation management.
Technical expertise in design and analysis of Electromechanical Systems and components such as wearable drug delivery systems
Ability to complete all activities with the highest regard for all the company's divisional and local site procedures for safety, quality, and regulatory compliance.
Excellent oral and written communication skills
Preferred Experience and Skills:
5+ years of experience in electro mechanical systems in medical device, pharmaceutical or biotech organizations.
Experience with regulations for medical device or combination products related electromechanical systems and its life cycle management
Experience leading and enabling diverse teams.
Knowledge of sterile and non-sterile combination products.
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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