Senior Engineer, Devices and Combination Product Technology (Hybrid)
USA - New Jersey - Rahway
Job Description
We are seeking a Growth and Improvement minded Senior Engineer in Device Technology that can help drive our Strategic Operating Priorities.
Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us
Summary, Focus and Purpose
The Senior Engineer is a key member of our Device Development and Technology Organization with responsibilities supporting the commercialization and sustainment of medical devices and combination products globally.
Experience in authoring ISO-13485 and 21 CFR 820 compliance technical documents, design controls, device risk management, medical device, combination products, prefilled syringes, autoinjectors, and related scientific/technical concepts and techniques are a must for this position. The ability to apply these in a fast-paced operating environment to resolve issues and meet customer needs in a compliant manner are at the core of this position. The Senior Engineer will routinely face competing priorities, and must manage time effectively, while keeping stake-holders and team members informed with effective communication.
This individual will be expected to function as an independent contributor, supporting global and site-specific projects, including those related to Combination Products and Drug Delivery Systems. The role includes leading, enabling or consulting in the development and execution of related strategic plans for problem-solving and continuous improvement by working with internal and external partners.
The key stakeholders include our Company Manufacturing sites, External Manufacturing, R&D, Quality, Operations, Product Development groups, Regulatory Affairs, Procurement, and suppliers.
Key Functions
Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion.
Complete all activities with the highest regard for our Company divisional and local site procedures for safety, quality, and regulatory compliance.
Understand the big picture, and how activities link to our Company …
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Hybrid Hybrid work model
Benefits/PerksCareer growth opportunities Collaborative culture Flexible work arrangements Hybrid work Hybrid work model Inclusive environment Insurance Meetings Paid holidays Retirement benefits Sick Days Vacation
Tasks- Collaboration
- Communication
- Communications
- Compliance
- Innovation
- Leadership
- Project management
- Resolve issues
- Risk Management
- Technical writing
- Technology Transfer
Analysis Animal Health Biomedical Engineering Business Operations Change Control Chemical Engineering Collaboration Combination products Commercial Communication Compliance Continuous Improvement Design Design Controls Deviation management Device technology Engineering GMP GMP Documentation Innovation ISO 13485 Leadership Management Manufacturing Mechanical Engineering Medical Devices Oncology Problem-solving Procurement Product Development Project Management Quality R Regulatory Regulatory Affairs Regulatory Compliance Research Risk Management Safety Stakeholder communication Technical Technical Leadership Technical Writing Technology Technology Transfer Vaccines
EducationBiomedical Engineering Business Chemical Engineering Communications Engineering Management Mechanical engineering Oncology Science
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