Senior development engineering

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

#J-18808-Ljbffr Planet Pharma