Product Development and Test Engineer

London. Full Time, Entry Level

We have an immediate opening for an Engineer to work closely with senior design engineers in a dynamic Medical Device Research and Development environment.

Product Development and Test Engineer

London. Full Time, Entry Level

We have an immediate opening for an Engineer to work closely with senior design engineers in a dynamic Medical Device Research and Development environment. This is a high visibility role with a significant direct impact on the success of the project by making sure planned design changes will meet medical electrical safety requirements of IEC 60601 1 and associated standards.

Responsibilities:
  • Participating in conceptual design discussions, design reviews, requirements development, bench testing, and formal design verification testing.
  • Writing test plans and test procedures.
  • Coordinating tests with contract test laboratories
  • Contributing to design failure investigations and root-cause analysis.
  • Participating in and contributing towards regulatory submissions.
Requirements:
  • BS degree in Electrical and/or Biomedical Engineering.
  • Sound understanding of engineering fundamentals.
  • Proficiency with basic electrical circuit analysis.
  • Demonstrated ability to set up and solve engineering problems.
  • Ability to work as part of an interdisciplinary team.
  • Self-motivated and able to self-prioritize.
  • Ability to clearly explain objectives.
  • Understanding of transformers, power electronics, RF electromagnetic theory.
  • Medical device industry experience preferred.
  • Experience with research, development, and product testing.
  • Broad measurement instrument knowledge.

Associate R-D Engineer

London. Full time. 2+ years experience

The main purpose of this job is to support development of current and next generation drug-coated balloon (DCB) projects to treat peripheral vascular disease.

Associate R-D Engineer

London. Full time. 2+ years experience
Position Description:

The main purpose of this job is to support development of current and next generation drug-coated balloon (DCB) projects to treat peripheral vascular disease. These combination products integrate biotechnology, polymer science, and pharmaceutical molecules onto balloon platforms. As the Medtronic DCB portfolio has grown, additional resources are needed to support combined research and development (R&D) and design assurance engineering (DAE) activities. The employee will be a member of multiple projects through different stages of the product development cycle, bringing products to commercialization.

Position Responsibilities:

Operations Value-Stream/Sustaining Projects: With multiple DCB projects in process across Medtronic sites, a dedicated technical R&D resource is needed to provide design input and assessment on changes being implemented by Operations. Additionally, many value-stream initiatives with substantial cost savings need R&D support to be approved/implemented.

Test Method Validation: The hired resource will also support TM validations for DCB projects in early development phases, to ensure that testing is accurate, repeatable and clinically relevant.

Other general responsibilities include:
  • Assist in the development of new combination products and components.
  • Support the development and integration of new technologies into the cardiovascular product offering.
  • Provide assistance to interdepartmental team for new product introduction.
  • Take an active role in early stage design control activities leading to a first in man study (innovation, proof of principle, product development, process development, and equipment development) such that a robust pilot line that is scalable and transferable to commercial manufacturing is achievable.
  • Document research and development process through lab notebooks, engineering characterization studies, and test reports.
  • Work with Regulatory Affairs (RA) to compile US and OUS regulatory submissions. Assist RA with answering subsequent questions from regulatory bodies.
  • Design and develop new test methods and equipment specific to new products. Train technicians in new processes.
  • Create document change orders (CO’s) for design, materials, and process documentation.
  • Work with Regulatory, Preclinical, Quality, and Manufacturing departments to create product performance, design, and manufacturing specifications.
  • Perform competitive product analyses.
  • Work with patent counsel to file and evaluate intellectual property.
  • Interact frequently with all departments within organization and occasionally with external physicians, consultants, and vendors.
  • Minimum travel requirement of 10%.
Basic Qualifications:

IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME

Bachelor’s Degree in Engineering (Chemical, Materials, Mechanical or Biomedical) or Chemistry

Desired Qualifications:
  • Master’s or PhD degree.
  • 2+ years working in R&D, Quality and/r Manufacturing on combination medical devices.
  • Experience with test method validation.
  • Knowledge of design of experiments (DOE) and statistical techniques.
  • Proficient with Solid Works
Specialized Knowledge or Skills
  • Experience in R&D, Quality and/or Manufacturing in a regulated industry, working through different phases of product development.
  • Complete understanding and wide application of technical principles, theories, and concepts toward product, process, and technology development and evaluation.
  • Able to provide imaginative, thorough and practical technical solutions to a wide range of difficult problems, consistent with company’s objectives.
  • Successful collaboration as part of a cross-functional team.
  • Background demonstrating strong self-motivation; able to works under only general direction, independently determining and developing approaches to solutions.
  • Proficient with computer applications (i.e. Word, Excel, PowerPoint, Minitab, etc.).
  • Ability to communicate well (both written and verbal).
Physical Requirements:

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to be independently mobile.

The employee is also required to interact with a computer, and communicate with peers and co-workers.

Able to lift 25 pounds, Able to view items through microscope, Extended periods of time doing computer-based work.

Must be able to travel independently to various Heal Crypto Mine sites.