Product Engineer, 3 yrs + exp in Product Design. Knowledge of Med Device Industry.
Nypro Healthcare, a subsidiary of a US multinational, specialises in the development and manufacturing of medical devices for the healthcare sector.
Located in Ireland, Bray, Nypro Healthcare is the European Centre of Excellence for Nypro for the development of medical devices including delivery of proof of concept, initial prototyping, clinical trial support, validation leading to full manufacturing of medical devices for global markets. Nypro uses state of the art injection moulding processes and integrated complex automated assembly lines within cleanroom manufacturing environments. Our customers include the world’s leading pharmaceutical and healthcare companies.
As part of our continued growth we currently have a vacancy for a Product Engineer.
As a Product Engineer you will be involved in the development and qualification of complex medical devices.The role is expected to apply knowledge from mechanical and manufacturing backgrounds to prepare product specification, maintain engineering control, develop product assembly solutions and develop testing requirements to meet Regulatory submission. Collaborate to provide technical guidance and support to internalcross-functional team such as Design, Quality and Manufacturing.
Device electro mechanical mechanism development and testing
Development of required Engineering Studies & Feasibility Reports, with focus on detail and quality
Definition of Product Requirements into Product Specifications
Protocol testing and specification development for verification, validation protocols and reports
Development of inspection techniques and engineering test method developments
Lead product and manufacturing Risk Assessment / Analysis documentation (PHA, FTA, dFMEA / uFMEA)
Plan and carry-out design verification / validation activities
Applies a project management approach to all deliverables, involving key stakeholders with ability to communicate in a structured manner both internally and externally
- Provide technical support to key vendors / sub-contract manufacturers
- All functions to be performed in strict accordance with the Quality Management System
- Strong knowledge of testing instrumentation and international Standards e.g. Tensile Testers, IST,Packaging, ISO Standards, DIN, etc
- Conduct proof of concept experiments and design other testing requirements as needed.
Engineering Degree and/or Master’s in Mechanical or Biomedical Engineering
Minimum 3 Years product engineering experience in preferably in medical devices
Strong Manufacturing skills, with a working knowledge of 2D/3D CAD
Knowledge of materials and processing techniques (polymers, metals, ceramics), including rapid prototyping
Strong knowledge of root cause analysis techniques, engineering theories, design of tests and practices, and documentation control techniques.
Strong technical writer
Strong communication skills with an ability to successfully manage cross functional teams.
Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820).
Attention to detail and Quality Focus
Knowledge of manufacturing processes within a clean-room environment
Knowledge of statistical techniques and DOE
Knowledge of engineering test development for reliability
The applicant must be a motivated and enthusiastic individual, self starter capable of planning and managing own responsibilities with little input. They must also be a team-player that can develop strong working relationships within a cross-functional team.