Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you will help bring medicines to the world even faster by imagining what’s possible and taking action.
What You Will Achieve
- Responsible for device lifecycle management of on-market medical devices and combination products
- Develop change management technical impact assessments, design and development plans, risk management and design verification plans, test methods and data analysis.
- Ensure the design controls are documented in accordance with internal procedures.
Role Responsibilities
- Lead design changes, process changes and risk management updates. Track progress and communicate status to management
- Guide, motivate and/or oversee the activities of individuals and teams with focus on project/program issues
- Liaison between GTEL Device Engineering and external production sites, Regulatory, and Quality colleagues
- Plan and execute technical strategy, protocols, tests and reports for line extensions and market expansion activities with production sites and Regulatory Affairs
- Establish and review specifications / requirements for components, products and processes
- Identify Design History File (DHF) enhancements / updates for specific device presentation / platform
- Assess trends in post-market surveillance and production controls to identify and execute continuous improvement activities for device presentation / platform and processes
- Support investigations of delivery system customer complaints to determine root cause and implement appropriate corrective and preventive actions
- Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material / processes / changes to assure reliability requirements are met
- Identify, communicate, and develop mitigation strategies for technical risks with key stakeholders per appropriate escalation thresholding
- Contributor to Annual Product Record Review
- Represent device engineering on change / CAPA review board, as needed
Basic Qualifications
- Applicant must have a High School Diploma (or Equivalent) with 10+ years of relevant experience;
- OR an Associate’s degree with eight years of experience;
- OR a Bachelor’s degree with at least 5+ years of experience;
- OR a Master’s degree with more than three years of experience;
- OR a Ph.D. with 0+ years of experience.
- Prior experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or Quality.
- Strong knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products.
- Experience analyzing patient/user impact.
- Experience in a GMP regulated industry.
- Understanding and practical knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and related standards.
- Critical thinking, and problem-solving skills.
- An ability to work independently as well as a member of a team in a fast-paced environment.
- Working knowledge of statistical methods for data analysis
- Experience with Computer Aided Design (CAD) software.
PHYSICAL/MENTAL REQUIREMENTS
- Hybrid role supporting virtual teams via webex and phone.
- Flexibility required when working with global colleagues in various time zones.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Must be able to travel up to 20%.
Work Location Assignment: Hybrid
Last Date To Apply: January 29, 2025
The annual base salary for this position ranges from $96,300.00 to $160,500.00.
