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- Tasks: Lead process validation and optimise manufacturing for innovative orthopaedic devices.
- Company: Cutting-edge MedTech company revolutionising medical device manufacturing.
- Benefits: Flexible remote work, valuable experience, and a chance to make an impact.
- Why this job: Join a dynamic team and contribute to life-changing medical solutions.
- Qualifications: Experience in process validation and knowledge of FDA regulations required.
- Other info: 12-month contract with opportunities for professional growth in a fast-paced environment.
The predicted salary is between 36000 - 60000 £ per year.
We are seeking an experienced Process Engineer to join our innovative MedTech company for an exciting contract opportunity. Specialising in cutting-edge orthopaedic products, we are at the forefront of medical device manufacturing, utilising advanced laser-based additive manufacturing technologies to deliver life-changing solutions to patients.
This 12-month contract role offers the perfect opportunity to make an immediate impact in a fast-paced, innovative environment while gaining valuable experience in advanced additive manufacturing and regulatory compliance. This is a remote position offering flexibility while working with a dedicated team committed to excellence in medical device development and manufacturing.
Key Responsibilities- Lead and support process validation activities across manufacturing operations, ensuring compliance with ISO 13485 and FDA CFR requirements.
- Develop, implement, and maintain robust manufacturing processes for orthopaedic medical devices using laser-based additive manufacturing technologies.
- Conduct Process Failure Mode and Effects Analysis (PFMEA) in accordance with ISO 14971 risk management standards.
- Drive continuous improvement initiatives to optimise process efficiency, quality, and compliance.
- Collaborate with Quality Assurance, Regulatory Affairs, and R&D teams to ensure seamless product development and commercial manufacturing.
- Prepare and maintain comprehensive process documentation, including validation protocols, reports, and standard operating procedures.
- Support investigations and implement corrective and preventive actions (CAPA) for process-related non-conformances.
- Ensure all processes meet stringent regulatory requirements for medical device manufacturing.
- Proven experience in process validation (IQ/OQ/PQ) within a regulated manufacturing environment.
- Strong understanding of ISO 13485 Quality Management Systems.
- Working knowledge of FDA Code of Federal Regulations (CFR), particularly 21 CFR Part 820.
- Hands-on experience with laser-based additive manufacturing processes.
- Demonstrated expertise in PFMEA methodologies and ISO 14971 risk management.
- Experience with orthopaedic or implantable medical devices.
- Knowledge of additional additive manufacturing technologies.
- Familiarity with design controls and design history file requirements.
- Experience with statistical process control and data analysis tools.
Process Engineer - Contract employer: Lynx Recruitment Limited
Contact Detail:
Lynx Recruitment Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Process Engineer - Contract
✨Tip Number 1
Network like a pro! Reach out to your connections in the MedTech industry, especially those who work with orthopaedic products. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for virtual interviews by practising common questions related to process validation and regulatory compliance. We recommend setting up a mock interview with a friend to get comfortable discussing your experience with ISO 13485 and FDA regulations.
✨Tip Number 3
Showcase your skills! Create a portfolio that highlights your hands-on experience with laser-based additive manufacturing and PFMEA methodologies. This will give you an edge when discussing your qualifications during interviews.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Process Engineer - Contract
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Process Engineer role. Highlight your experience with process validation and any relevant MedTech knowledge. We want to see how your skills align with our cutting-edge work in orthopaedic products!
Showcase Your Experience: In your cover letter, don’t just list your qualifications—tell us about specific projects where you’ve led process validation or implemented improvements. We love hearing about real-world examples that demonstrate your expertise!
Be Clear and Concise: Keep your application clear and to the point. Use bullet points for key achievements and avoid jargon unless it’s relevant to the role. We appreciate straightforward communication that gets right to the heart of your experience.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It helps us keep track of applications and ensures you’re considered for this exciting opportunity in our innovative team!
How to prepare for a job interview at Lynx Recruitment Limited
✨Know Your Stuff
Make sure you brush up on your knowledge of ISO 13485 and FDA CFR requirements. Being able to discuss these regulations confidently will show that you’re serious about compliance and understand the industry standards.
✨Showcase Your Experience
Prepare specific examples from your past roles where you’ve successfully led process validation activities or implemented continuous improvement initiatives. This will help demonstrate your hands-on experience with laser-based additive manufacturing and how you can make an immediate impact.
✨Be Ready for Technical Questions
Expect questions around PFMEA methodologies and risk management. Practise explaining how you’ve applied these in previous projects, as this will highlight your expertise and problem-solving skills in a regulated environment.
✨Collaborate and Communicate
Since this role involves working closely with Quality Assurance, Regulatory Affairs, and R&D teams, be prepared to discuss how you’ve effectively collaborated in the past. Highlighting your teamwork skills will show that you can thrive in a dedicated team environment.
