Junior HIL Validation Engineer responsible for reviewing test procedures and validating system requirements. Working in a hybrid model for a global engineering and consulting service provider.
About the role
- R&D Engineer overseeing Biologics and Regenerative Medicine project plans at Smith+Nephew. Collaborating across teams for innovation and product development in healthcare technology.
Responsibilities
- Oversee the design and execution of BRM’s project plans that integrate early innovation & feasibility and product characterization and development to support the pipeline and portfolio programs
- Act as primary contact and provide oversight to CRO/CDMO partners to ensure consistent practices across vendors, groups and sites, communicate and trouble-shoot issues and track/forecast activities
- Preparation and review of protocols, abstracts and manuscripts, study and technical reports for their inclusion in either regulatory and/or marketing support
- Collaborate with cross functional teams (Clinical Affairs, Safety, Regulatory Affairs, QA, QC, Manufacturing, other subject matter experts) to deliver BRM project needs
- Maintain current, in-depth product knowledge, including current developments, scientific and clinical literature review, therapeutic and product operation knowledge, as well as related new technologies for technology assessment
- Facilitate medical device development and sustaining through design controls including but not limited to, DHF creation and maintenance, user needs, design inputs, verification & validation testing, and working in a quality management system
- Mentor junior engineers and scientists.
Requirements
- Bachelor's Degree with 2+ years' experience in a relevant scientific or engineering discipline required
- Master’s Degree in a relevant scientific or engineering discipline preferred
- Minimum 2 years of relevant experience with demonstrated ability to work in the lab setting and experience with physical chemistry and formulation
- Excellent communication skills and interpersonal/team effectiveness, ability to communicate to various levels of management
- Proven ability to deliver results in a matrix organization and effectively collaborate with leadership.
Benefits
- 401k Matching Program
- 401k Plus Program
- Discounted Stock Options
- Tuition Reimbursement
- Flexible Personal/Vacation Time Off
- Paid Holidays
- Flex Holidays
- Paid Community Service Day
- Medical, Dental, Vision
- Health Savings Account (Employer Contribution of $500+ annually)
- Employee Assistance Program
- Parental Leave
- Fertility and Adoption Assistance Program
- Discounts on fitness clubs, travel and more!
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