Senior Research and Development Engineer

Why You’ll Love Working at Cook:

At Cook, we believe in taking care of our people so they can take care of others. As a global, family-owned company that has been improving patients’ lives since 1963, we’re committed to doing business with integrity and making a positive impact in the communities where we live and work. We’re guided by strong ethical standards and core values, and we believe the best ideas come from creating solutions together. Our company culture values every voice, brings together inclusive teams who collaborate well, and encourages learning and innovation. When you join Cook, you’re not just starting a job, you’re building a career with purpose, in a company that invests in you. 

What You Can Expect at Cook:

These are some ways we support our people across Cook: 

• Meaningful work & strong values: Contribute to improving patient care globally in a company known for high ethical standards and integrity. 
• Competitive rewards & security: Competitive, performance-related compensation and benefits that support your health and financial wellbeing. 
• Flexibility & time off: Paid time off, holidays, and hybrid or remote work options for many jobs, where possible.  
• Growth & development: Learning opportunities, educational assistance, and development programs to help you grow your skills and career. 
• Wellbeing & community: Health and wellness initiatives, social activities, and community engagement that help you feel connected and supported. 

Our employee benefits include:   

• Hybrid Work Model    

• Company sponsored Defined Contribution pension scheme   

• Medical Health Insurance cover for you and your immediate family   

• Life Assurance and Income Protection cover   

• Educational Assistance    

• Performance related Bonus   

• Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks   

• Fully equipped gym on site   

• 39-hour week with flexible start & finish times    

• Paid time off to participate in volunteer activities   

• Free parking   

• Subsidised restaurant   

• Sports & Social club 

The Senior Research and Development Engineer will be a technical leader and/or growing subject matter expert, applying engineering principles to solve complex technical challenges and ensuring products meet clinical needs, safety requirements, and quality standards.

In this role, they may have the following responsibilities:

• Lead small projects/programs and/or have ownership of portions of medium to large projects/programs while also supporting other project teams, as needed.
• Collaborate across functional department(s), grow and advance their area of technical expertise, and provide guidance and technical leadership within their area.
• Create procedures or white paper guidance for functional groups in focus area(s) of work.

Lead the design, development and verification of prefilled syringe and drug–device combination products from concept through design freeze and transfer to manufacture, owning the design control and test method evidence that supports them.

It would be an advantage if the candidate also has working knowledge of the following areas:  

• Vascular intervention or syringe-based delivery system experience.
• Autoinjector or on-body delivery system experience.
• Human factors and usability engineering under IEC 62366.
• Experience supporting IND, IMPD, 510(k), PMA or Design Dossier submissions.
• ISO 11040 (prefilled syringes) — essential.
• ISO 11608, ISO 7886 and ISO 80369.
• ISO 14971 (risk management) and ISO 10993 (biological evaluation).
• 21 CFR 820.30 (design controls), 21 CFR Part 4 (combination products) and EU MDR 2017/745
• Cognition Cockpit — requirements management, design control and traceability (strongly preferred).
• Design History File

• Continue to perform the functions, duties, and expectations of the Research and Development Engineer 2 at a high level, as applicable.
• Responsibilities for supporting technical leadership may include:
  • Leading technical development of small projects/programs and/or ownership of portions of medium to large projects/programs.
  • Leading all key design decisions to ensure quality of design selection to meet customer needs.
  • Retrospective project reviews to understand lessons learned.
  • Implementation of strategic goals within area of expertise.
• Responsibilities for providing subject matter expertise may include:
  • Work with senior leadership to identify and agree on focus area(s) for their projects across the functional department(s).
  • Conduct research and contribute to the development of best practices in focus area(s).
  • Create procedures or white paper guidance for functional groups.
  • Deploy knowledge, training, and ensure correct implementation of new concepts and/or approaches.
• Work closely with SME’s, physicians, and product managers to develop innovative medical devices to improve patient care, as applicable.
• Lead the activities of small projects/programs and drive project tasks to ensure timely completion of project milestones, and that business metrics are achieved in collaboration with project manager(s) (when one is assigned).
• May also assume responsibility in interpreting data, organizing, executing, and coordinating project activities within portions of projects/programs.
• Lead the development and execute activities and documentation to create and maintain design history files.
• Assists with the development and implementation of new processes and solutions that will impact the achievement of the department business metrics.
• Implement subject matter area specialization to support the department.
• Provide technical input on company intellectual property relevant to area of work to drive innovation and IP generation.
• Utilize innovative and creative problem-solving techniques to develop and implement cutting edge medical devices and technologies, overcoming complex engineering challenges and driving product/process excellence to support projects/programs across functional groups.
• Build, communicate, and manage effective relationships with cross functional groups to achieve business metrics and project milestones.
• Apply the organization’s business processes and systems, as applicable to your duties and responsibilities.
• Ensure with Quality, Regulatory, and company policies and systems.
• May represent Cook in industry standards, working groups and present on Cook’s behalf in industry conferences.
• Act as a mentor to other personnel fostering an environment of collaborative knowledge sharing and continuous learning.

Essential Regional or Country RequirementsEducation and/or Work Experience

• Bachelor’s degree in Engineering and 5 years’ relevant experience. Relevant advanced degrees (Master’s or PhD) may reduce the experience requirement by 2-4 years.
• Experience in a technical role within Medical Device or regulated industry/adjacent experience.
• Project/technical leadership experience preferred.

Knowledge and Skills and/or Abilities

• Strong analytical and critical thinking skills.
• Strong technical writing.
• Proven ability to work with cross functional teams to solve complex problems.
• Ability to develop new products and processes in achieving functional objectives.
• Knowledge of relevant ISO, EU, FDA medical devices standards regulations is preferred.
• Project management methodology and skills is preferred.
• This role requires fluency in Artificial Intelligence (AI) and data concepts, including the ability to critically evaluate AI outputs, improve workflows using approved tools, identify and mitigate bias or inaccuracies, and communicate AI-driven insights clearly and responsibly to peers and managers.
• Demonstrated fluency in both written and spoken English, and in other local language(s), as applicable.

Physical Requirements

• Work under general office environmental conditions.
• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
• In line with local health and safety requirements, personal protective equipment may be required in areas associated with this position.
• May require occasional travel.