Senior Research and Test engineer

J&J Family of Companies; Leeds; On-site; GBP 52,000 - 70,000; Full time

Job summary

DePuy Synthes, a Johnson & Johnson company, is seeking a Senior Test Engineer to contribute to verification and risk assessment of medical implants and instrumentation for Kinimatic/Tribological applications. This hands-on role supports R&D and Quality to develop test methods and ensure testability of requirements.

You will develop test plans, communicate results, mentor staff, collaborate across functions, and assist with audits and DHF documentation; 4+ years in medical devices and a relevant

Qualifications

• Bachelor's degree in Mechanical, Electrical, Biomedical Engineering, Materials Science, or related field.
• Minimum 4 years in the Medical Device industry.
• 2 years in Tribology or related area.
• Experience with transducers and data acquisition systems.
• Experience with data processing and statistical analyses.
• Experience with technical writing and plans/protocols.

Responsibilities

• Perform verification tests to support regulatory submissions and investigations.
• Develop test methods including test plans, protocols, fixtures, validation, data analysis, and reports.
• Communicate test findings and propose resolutions to teams.
• Collaborate with development, manufacturing, regulatory, and vendors to execute test protocols and generate reports.
• Mentor students and staff; participate in PFMEAs and design reviews.
• Lead internal projects with a test/research focus; contribute to DHF updates and audits.

Skills

Test planning

Protocol development

Fixture development

Data analysis

Statistical analysis

Technical writing

Problem solving

Education

Bachelor's degree in Mechanical/Electrical/Biomedical/Materials Science or related field

Tools

Load cells

LVDTs

Strain gauges

Data acquisition systems

3D motion tracking systems

Job description

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., 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.
  Minimum of a Bachelor's degree or equivalent in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Material Science or other related fields, 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
  At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 (https://www.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.