Sr. Engineer, Device Development

Principal Duties And Responsibilities

• Design medical device mechanical components and packaging.
• 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.

Qualification Requirements (continued)

• 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.
• 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.