Sr. Principal Device Engineer

Sr. Principal Device Engineer

Requirements

• Applicant must have BA/BS with 6+ years of experience or MBA/MS with 5+ years of experience or PhD 1+ year of experience
• Effective written and verbal communication skills
• Strong interpersonal skills and the ability to work collaboratively in a team environment across various business functions
• Experience in project management and leading complex projects
• Ability to develop and manage plans to achieve objectives
• 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.

Responsibilities

• 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.
• Lead highly complex design changes, process changes and risk management updates. Track progress and communicate status to management.
• Project management capability for managing complex projects involving stakeholders from multiple areas of the business
• Guide, motivate and/or oversee the activities of individuals and teams with focus on project/program issues.
• Lead the develop, implementation, and maintenance of processes and/or procedures cross functional in scope
• Liaison between GT&E Device Engineering Lifecycle Management (DELCM) and external manufacturing sites, Regulatory, and Quality colleagues for highly complex technical projects and process improvements
• Develop and execute strategies for lightspeed and/or accelerated development timelines
• Contribute expert level knowledge of device standards, regulations, processes and/or technology to ensure project success
• Plan and execute technical strategy, protocols, tests and reports for complex 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
• Manages the identification, communication, and development of mitigation strategies for complex 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
• Interface and manage vendors on design control related topics and activities
• Knowledge of design for manufacturing.

Preferred Qualifications

• Experience in problem-solving, negotiations, presentation, and supervision of a multi-layered organization
• Understanding of DAMIC (six sigma) tools and practices with a focus on continuous improvement
• Broad knowledge of technology transfer processes and manufacturing for Active Pharmaceutical Ingredients
• Good technical understanding of pharmaceutical processes and the impact of technical change
• Demonstrated experience and competence in organizing, planning, and problem-solving related to qualifying new API suppliers
• Strong leadership and team management skills
• Excellent analytical and strategic thinking abilities
• Ability to influence and drive alignment across stakeholders