Sr. Engineer, Device Development

Position Summary

This position will serve the role of medical device development engineer within Pharmaceutical Development. Experienced engineer who executes technical development of drug delivery medical devices and packaging.

Principal Duties And Responsibilities

• Design medical device mechanical components and packaging.
• Perform Design Failure Mode and Effects Analysis (DFMEA) and User Failure Mode and Effects Analysis (UFMEA).
• Lead design verification and validation (V&V), design outputs (drawings, specs), and feasibility assessments, including prototyping and lab testing.
• Collaborate with Quality, Regulatory, Human Factors, and Manufacturing teams, often managing relationships with external CMOs/suppliers.
• Author technical documentation to ensure compliance with FDA, EU, and ISO standards.
• Communicate project plans, status updates and progress against milestones to project team members including management.
• Generate technical documents including test protocols and reports documenting product and process knowledge.
• Display a strong understanding of product development and transfer needs of commercial development.

Qualification Requirements

• Minimum of a bachelor’s degree (advanced degree desirable) in Mechanical Engineering, Biomedical Engineering or related discipline.
• 8+ years of experience in medical device design, development and testing.
• Strong knowledge and understanding of medical device design controls and product realization processes.
• Strong knowledge of ISO 13485, ISO 14971, IEC 62366.
• Experience using 3D modeling software such as SolidWorks or ProEngineer.
• Capital project experience, including authoring User Requirement Specifications for processing equipment, vendor proposal selection, design review and Factory Acceptance Testing.
• Demonstrated ability to apply strong fundamental scientific and engineering skills to evaluate processes and develop practical solutions to technical challenges.
• Use of DoE and associated statistical methods for process and design space optimization.
• Demonstrated written and verbal communication skills.
• Demonstrated data analysis and problem-solving skills.
• High degree of initiative and self-motivation to meaningfully advance multiple tasks and projects.
• Strong interpersonal skills.
• Experience solving ambiguous problems.
• Experience creating technical, written content.

Working Conditions

• Production Floor – gowning requirements
• Bending
• Lifting