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. The role includes but is not limited to determining design input, generating design outputs, conducting design verification and validation, developing manufacturing and inspection processes, supporting GMP manufacturing of clinical trial material. This individual will execute assigned project activities and work with project team members to develop and manufacture the combination products. They may oversee the execution of project tasks and monitor the activities and deliverables of project aspects in a leadership role. The position is set in a dynamic and fast-paced environment.

Critical areas of focus will be mechanical design, testing, risk management activities, technical transfers, scale-up and new process development.

Principal Duties And Responsibilities Include The Following

• 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
• A hard-working, team-player that is passionate about science and can effectively collaborate in a dynamic, cross-functional matrix environment
• Geometric Dimensioning and Tolerancing (GD&T) practices
• Ability to interpret and draft technical drawings and schematics
• Experience designing and developing mechanical assemblies
• Strong understanding of mechanical engineering principles and methodologies
• Experience in plastic part design, extrusion techniques and injection molding
• Familiarity with best practices for implementing automated systems (e.g. GAMP)
• Drafting of regulatory submission documents and agency audit experience
• Working Conditions:
• Production Floor – gowning requirements
• Bending
• Lifting