Senior Research and Test engineer

8722-DePuy International Limited Legal Entity

Churwell

On-site

GBP 65,000 - 90,000

Full time

12 days ago

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Job summary

Johnson & Johnson's DePuy Synthes in Leeds, UK seeks a Senior Kinematics Test Engineer to contribute to verification and risk assessment of medical implants and instrumentations for Kinimatic/Tribological applications. The engineer will work with R&D and Quality teams to develop testability of requirements and test methods.

The role is hands-on, involves cross-functional collaboration, data analysis, and documentation to support design history files and regulatory submissions in a regulated

Qualifications

Minimum 4 years' experience in the Medical Device industry.
Minimum 2 years' experience within Tribology.
Experience with transducers (load cells, LVDT's, strain gauges) and data acquisition systems is required.
Experience with data processing and statistical analyses is required.
Experience with technical writing and testing in regulated environments is required.

Responsibilities

Perform verification tests to support regulatory submissions and quality investigations.
Develop test methods meeting complex requirement intent (plans, protocols, fixtures, validation, data analysis).
Communicate test findings and proposed resolutions to teams clearly and professionally.
Collaborate with development, manufacturing, regulatory affairs, and other teams to develop test protocols and reports.
Mentor students and junior staff.
Support design reviews and PFMEAs; contribute to DHF through data and reports.

Skills

Data acquisition systems

Statistical analysis

Technical writing

Experiment design

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in Mechanical Engineering or related field

Tools

Transducers (load cells, LVDTs, strain gauges)

Data processing software

Job description

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. 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

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
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 with medical device joint simulators is highly 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 activitiesExperience working in an agile project management environment
Experience with PLM applications
Knowledge of regulatory guidelines is preferred

Other: