R&D Engineer II (Ostomy)

We Make Life More Rewarding and Dignified 

Location: ​Ballina​
Department: ​ 

The R&D Engineer will play a key role in the design, development, and testing of medical devices and systems. Focus will be on learning, developing technical skills, and applying knowledge. Collaboration across multiple functions will be necessary to create innovative solutions, from the concept phase through product commercialization. The candidate will work with a multidisciplinary team and other R&D Engineers to solve complex problems while keeping the end user’s needs at the forefront. The R&D Engineer will need to be able to think creatively, be curious, and apply their technical expertise to drive and develop solutions that provide meaningful value to our customers, provide business outcomes, and maintain Regulatory standards. The role will include a combination of supporting the delivery of new products as well as improving and upgrading our existing product designs

Responsibilitities:

• Works on well-defined tasks and projects with guidance from senior engineers or managers
• Supports the design and development process
• Support the design and development of products including a high-level of design feasibility, prototype development, design, test method development, design verification/validation, and product commercialization
• Application of both new and existing technologies, materials, and processes to deliver a product
• Supports the creation of engineering specifications, drawings, and prototypes
• Ability to learn CAD Software (i.e. Solidworks) to develop and design concepts, components, and systems
• Develop prototypes and conduct hands-on testing to evaluate functionality and durability
• Support feasibility studies and risk assessments to ensure products meet regulatory requirements, performance specifications, and safety standards
• Support testing protocols to validate device performance against design specifications
• Understanding of problem-solving behaviors and activities such as Root Cause Analysis, Design of Experiments (DOEs), and other problem-solving tools
• Conduct analysis of data and develop detailed reports and recommendations
• Collaborate with clinicians and end-users to gain an understanding of their needs. Support the creation of user needs and ensure the optimization of product functionality and performance based upon their feedback.
• Prepare technical documentation in accordance with regulatory and design control requirements
• Develop and maintain relationships with cross-functional team members (i.e. marketing, design assurance, global engineering, operations, project management, clinical)
• Analyze existing devices and processes to identify opportunities to enhance customer needs, quality, cost, and/or production

Functions of the Role:

• Ability to work in a laboratory setting and use prototype machinery  
• Ability to lift 15-25kg
• Ability to travel as needed to Hollister manufacturing facilities and vendor locations

Educational and Experience Requirements:

• Bachelor’s degree in Science related discipline and minimum 2-5 years of experience OR
• Master’s Degree in Science or Engineering preferred
• Experience in Research & Development, ideally in medical device industry
• Experience in project management
• Experience in quality 

Specilaized Skills/Technical Knowledge:

• Solid understanding and capable of designing and developing medical devices across various stages (concept, prototyping, testing, production)
• Some experience with Design Controls including documentation of design history files (DHF), risk management files, failure mode effects analysis (FMEA), traceability matrices, and verification and validation (V&V) processes
• Ability to learn, execute tasks, and build experience
• Familiarity with ISO 13485 (Quality Management System for Medical Devices)
• Experience with prototyping
• Effective verbal and written communication skills both Lithuanian and English
• Experience collaborating across multidisciplinary teams (marketing, design assurance, engineering, operations, regulatory, clinical, etc.)

Local Specifications: 

Language: English

About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Req ID: 34598