Senior Research and Test engineer

Johnson & Johnson MedTech; Leeds; On-site; GBP 45,000 - 65,000; Full time

Job summary

Johnson & Johnson MedTech in Leeds, UK, seeks a Senior Kinematics Test Engineer to contribute to verification, validation and risk assessment of medical implants and instrumentations. This hands-on role requires collaborating with R&D and Quality teams to ensure testability of requirements and robust test methods.

The ideal candidate has 4+ years of medical device testing experience, knowledge of tribology, data acquisition and statistical analysis, and strong technical writing skills.

Qualifications

• Bachelor's degree or equivalent in Mechanical, Electrical or Biomedical Engineering or related field.
• Minimum 4 years in the Medical Device industry with hands-on testing experience.
• Experience with transducers and data acquisition systems is required.
• Experience with joint simulators and regulated testing is highly preferred.

Responsibilities

• Perform verification tests to support regulatory submissions and product development.
• Develop test methods, protocols, fixtures, and validation plans.
• Communicate findings and resolutions clearly to cross-functional teams.
• Collaborate with development, manufacturing, regulatory affairs and QA to execute test protocols.
• Mentor junior staff and contribute to design FMEAs and DHF documentation.
• Lead internal projects with strong test/research focus and participate in audits.

Skills

Data acquisition

Statistical analysis

Technical writing

Verbal communication

Problem solving

Education

Bachelor's degree in Mechanical Engineering or related field

Tools

Load cells

LVDTs

Strain gauges

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

R&D Operations

Job Sub Function

Product Development Testing

Job Category

Professional

All Job Posting Locations:

Leeds, West Yorkshire, United Kingdom

Job Description

DePuy Synthes is recruiting for a Senior Kinematics Test Engineer, located in Leeds, UK

The Senior Test Engineer contributes with limited guidance to the research, design characterization, verification and risk assessment of medical implants and instrumentations for Kinimatic/Tribological applications. The engineer will work closely with R&D engineering and Quality engineering to develop and ensure the testability of requirements, while developing test methods that will holistically verify the safety and efficacy of the medical devices (implants and instrumentations). This is a hands‑on engineering role which touches on various engineering fields required for formal testing of complex medical devices and systems. Additionally, the individual will have the opportunity to propose improvements to our existing processes to improve the team’s quality and efficiency.

Key Responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Perform verification tests to support regulatory submissions, investigational tests to support new product development and quality investigations, and research to improve product designs
• Develop test methods that meet complex requirement intent (including but not limited to: test plans, protocol development, fixture development, test method validation, data analysis, test report and summary document generations)
• Clearly and professionally communicate test findings, technical challenges and proposed resolutions to teams
• Works with development engineers, manufacturing, regulatory affairs, product directors, equipment and materials vendors and other team members to develop and execute test protocols, creating technical reports and contribute to peer reviewed publications in multi-functional projects.
• Mentor students and other technical staff
• Participate in the review processes for function of current and new product (including investigative skills to evaluate customer complaints) and contribute in design FMEAs and process PFMEAs
• Must be able to work individually and as part of a team in development projects, possibly leading internal projects with a strong test/research bias
• Must be effective in cross functional projects and work in a global team and execute test procedures in line with company/international procedures/specific country requirements to generate data required for the design verification section of the product development and design history files (DHF).
• The Senior Test Engineer will take the lead in understanding, revising, and implementing departmental work instructions to ensure consistency in all DePuy Synthes laboratories.
• Assist with departmental internal and external quality audits to ensure compliance and remediation.

Qualifications

Education:

• Minimum of a Bachelor’s degree or equivalent in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Material Science or other related fields

Experience And Skills

Required:

• Minimum of 4 years’ experience in the Medical Device industry
• Minimum of 2 years’ experience within Tribology/
• Experience with transducers (load cells, LVDT’s, strain gages, etc.) and data acquisition systems is required
• Prior experience with medical device joint simulators is highly preferred
• Experience with data processing and statistical analyses is required
• Experience with technical writing is required
• Prior experience writing plans/protocols and performing formal testing in a regulated industry is required·
• Good Laboratory Practice/ Good Documentation Practice
• Verbal and written communication skills
• Statistical analysis
• Problem analyzing and solving
• Ability to effectively work on multiple tasks

Preferred

• Prior experience or general knowledge in fixture development and qualification is required
• Experience with 3D motion tracking systems or 3D optical test/inspection systems is preferred
• Experience with instrument qualification and validation activities
• Experience working in an agile project management environment
• Experience with PLM applications
• Knowledge of regulatory guidelines is preferred

Other

• Up to 10% of time may be expected for domestic and international travel

Required Skills

Preferred Skills:

Business Behavior, Business Case Modeling, Clinical Data Management, Coaching, Communication, Healthcare Trends, Health Sciences, Innovation, Laboratory Operations, Market Research, Problem Solving, Product Development, Product Improvements, Product Strategies, Project Management, Report Writing, Research and Development, Use of Laboratory Equipment