Test Engineer

Johnson & Johnson Services; Leeds; Sur place; GBP 55 000 - 90 000; Plein temps

Avantages offerts par ce poste

Private healthcare

Digital GP

Gym memberships

Retail vouchers

CSR programme

Résumé du poste

Johnson & Johnson is seeking a Senior Test Engineer to support verification and risk assessment of medical implants and instrumentation in Kinimatic/Tribological applications. This is a hands-on role working with R&D and Quality to develop test methods that ensure safety and efficacy of devices.

You will lead test protocol development, data analysis, and reporting, mentor staff, participate in FMEAs/PFMEAs, and collaborate across global teams to meet regulatory requirements.

Qualifications

• Bachelor's degree in a relevant engineering field with 4+ years in medical devices.
• 2+ years of Tribology experience.
• Experience with transducers and data acquisition systems.
• Experience with medical device joint simulators.
• Good Laboratory Practice and Good Documentation Practice.

Responsabilités

• Perform verification tests to support regulatory submissions and investigations.
• Develop test methods including test plans, protocols, fixtures, validations, data analysis and reports.
• Communicate findings and resolutions to teams clearly and professionally.
• Collaborate cross-functionally to develop and execute test protocols and generate technical reports; contribute to publications.
• Mentor students and junior staff.
• Participate in reviews and contribute to FMEAs/PFMEAs.

Connaissances

Tribology experience

Data acquisition

Transducers

3D motion tracking

Regulatory knowledge

Agile project management

PLM tools

Verbal communication

Written communication

Formation

Bachelor's degree in engineering (Mechanical/Electrical/Biomedical/MMS)

Outils

PLM software

Data acquisition systems

Description du poste

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 of 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, 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, 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.

• Up to 10% of time may be expected for domestic and international travel
• What’s in it for YOU? It’s important to us that you feel you can bring your whole self to work; at Depuy Synthes we provide an environment for you to fulfil your career aspirations as well as promoting your physical and mental wellbeing. As part of our offering, you will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. Examples of this include: online Digital GP, private healthcare, Retail Vouchers, Discounted & Subsidised Gym memberships and you can get to support community projects as part of our global Corporate Social Responsibility programme. Depuy Synthes is a supporter of equal opportunities and is a proud member of Disability Confident.