Senior Lead Engineer - Chemical & Materials

We Make Life More Rewarding and Dignified 

Location: ​Ballina​
Department: ​Operations 

Summary: 

The position based in Ballina will liaise with Research and Development (R&D), Manufacturing Operations, New Product Development (NPD), Quality Assurance(QA), Design Assurance (DA) & Supply Chain(SCM) to effectively carry out its responsibilities. 

This person will lead and coordinate Chemical & Materials engineering activities associated with the development of new and existing manufacturing technologies. The position will utilize learnings from external and internal technical development work to support the overall objective of executing work on time, on budget and to the necessary Quality and Regulatory standards. The role will lead chemical process development and chemical management requirements, along with material selection, preparation, characterization and compatibility assessments to ensure product performance. It will include oversight of manufacturing performance and project execution, including liaising with cross site internal stakeholders and external vendors to achieve desired outcome. This role requires expertise in polymers, coatings and biocompatible materials used in medical device technologies.

Responsibilities: 

• Process Improvements: Position will be responsible for assessing manufacturing data, defining process requirements and identifying and implementing process & product improvements for chemical and material focused workstreams. Position will provide leadership to cross functional team to deliver on same objectives.
• New Processes Implementation: Optimize chemical processes, chemical reactions, coating application and surface treatment process for biocompatibility, durability, and manufacturability on highly automated production equipment. Conduct and interpret analytical and physical testing (e.g., DSC, FTIR, SEM, mechanical, chemical stability). Support product performance test method and implementation development.
• New Materials Development & Characterization: Lead material selection, processing requirements, test requirements and qualification for new product development and cost saving projects.
• Work Management: Position will be responsible for identifying, developing & tracking work plans and ensuring use of phase reviews or other suitable processes to create, support and manage development of goals, schedules and tasks. Also, position will be responsible for maintaining documented evidence of work completed and budgetary control.
• Process Concept Development: Position will be responsible for overseeing development of concept for fully automated manufacturing systems, working with a technology partner, driving proof of principle by prototyping key chemical and materials challenges, and developing a high level concept that meets customer requirements.
• Collaboration: Participate with peers, cross functional stakeholders and external vendors/ consultants in development, execution and monitoring of work plans and evaluation of product/ process concepts.
• Design Transfer Management: Conduct and document Design Transfer and Change Control implementation to move projects from the design to manufacturing phase.
• Process Qualification: support qualification of new products / processes, and ensure compliance to quality standards through execution of protocols.
• Safety/ Risk Assessments: position will be responsible for ensuring safety compliance in the area, and supporting both conduction and timely closeout of risk assessments.
• Communication: Pro-actively socialize key development opportunities and activities, milestone plans, progress and major interdependencies with Stakeholders on a regular basis. Present updates to senior leadership using clearly understood metrics to report progress management.

Work Experience:

• 8 - 12 years post qualification applicable experience.
• Knowledge and experience of Hydrophilic coating
• Demonstrated advanced analytical problem solving abilities
• Exceptional organization and communications skills
• Previous experience in technology development and execution of Chemical & Materials projects
• Good working knowledge of materials and relevant technologies
• Proven ability in conducting research and/or development activities, investigating and recommending solutions to problems affecting research and development activities, projects and/or initiatives
• Project Management Training/Qualification
• Familiarity with DOE techniques, statistical analysis tools, and/or DFM principles

Education Requirements: 

• A Bachelor’s Degree (Honours / Level 8) in Chemical Engineering or related discipline is required.
• Masters or PhD in a related discipline is preferred.
• Project Management experience is preferred.

Specialized Skills/Technical Knowledge:

Core Technical & Materials Engineering Skills

• Biocompatible materials & Biomaterials engineering (ISO 10993 biocompatibility)
• Surface modification, coatings, cure technology and sterilization (plasma, hydrophilic, UV, Thermal, e-beam)
• Polymer science — extrusion, injection molding, degradation behavior, additive compounding
• Adhesives, sealants, and bonding for medical assemblies
• Failure analysis for disposable devices (fractography, contamination, stress cracking)

Chemical Engineering & Process Development

• Process design and optimization for cleanroom manufacturing
• Formulation and compounding of medical polymers, adhesives, coatings
• Process validation (IQ/OQ/PQ) per FDA and ISO 13485 requirements
• Design of Experiments (DOE) and process optimization
• Scale-up from R&D to pilot and commercial production
• Chemical compatibility studies

Data, Quality & Analytical Skills

• Statistical analysis & SPC (Minitab, JMP)
• Measurement system analysis (MSA)
• Root cause analysis tools (5 Whys, Fishbone, FMEA)
• Material characterization: SEM, FTIR, DSC, TGA, DMA, tensile testing, contact angle
• Analytical chemistry for contamination control (GC-MS, HPLC, TOC)
• Risk management per ISO 14971

Design Control & Regulatory Knowledge

• Design controls, Design history file (DHF), Device master record (DMR), Technical File
• Change control and document management
• Risk-based validation of processes and materials
• Traceability of materials and components
• Environmental and chemical compliance

Leadership & Cross-Functional Collaboration

• Lead teams or individuals, using direct or indirect influence techniques.
• Coordinate activities across multi-functional and cross-geographical teams to meet deliverables.
• Mentor others by providing guidance, direction, or other (technical) expertise.
• Frequently demonstrate highly technical and professional competencies on medium to high profile projects
• Supplier qualification for materials and contract manufacturers
• Design Excellence input to design teams
• Effective technical communication with regulatory, quality, and operations teams

Project Management

• Use systematic techniques to break technical projects into fundamental task requirements.
• Obtain (negotiate for) resources as needed, communicate direction to team members, assign tasks as appropriate, and ensure that commitments are met.
• Monitor project progress to anticipate problems and develop solutions before they become critical, and use clearly understood metrics to report progress to management.

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: 35329