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- Tasks: Lead process validation and optimise manufacturing for innovative orthopaedic devices.
- Company: Cutting-edge MedTech company focused on life-changing medical solutions.
- Benefits: Flexible remote work, competitive salary, and opportunities for professional growth.
- Why this job: Join a dedicated team and make a real impact in the MedTech industry.
- Qualifications: Experience in process validation and knowledge of FDA regulations required.
- Other info: Dynamic role with a focus on continuous improvement and innovation.
The predicted salary is between 36000 - 60000 £ per year.
We are seeking an experienced Process Engineer to join our innovative MedTech company on a 12-month fixed-term contract. 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 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.
- Validation: Proven experience in process validation (IQ/OQ/PQ) within a regulated manufacturing environment.
- MedTech Regulatory Knowledge: Strong understanding of ISO 13485 Quality Management Systems.
- FDA Compliance: Working knowledge of FDA Code of Federal Regulations (CFR), particularly 21 CFR Part 820.
- Advanced Manufacturing: Hands-on experience with laser-based additive manufacturing processes.
- Risk Management: 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 employer: Lynx Recruitment Limited
Contact Detail:
Lynx Recruitment Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Process Engineer
✨Tip Number 1
Network like a pro! Reach out to professionals in the MedTech field, especially those who work with orthopaedic products. Use platforms like LinkedIn to connect and engage with them; you never know who might have a lead on your dream job!
✨Tip Number 2
Prepare for virtual interviews by setting up a distraction-free space. Make sure your tech is working smoothly, and practice answering common questions related to process validation and FDA compliance. We want you to shine when it’s showtime!
✨Tip Number 3
Showcase your skills through real-life examples! When discussing your experience with laser-based additive manufacturing or PFMEA, use specific instances that highlight your problem-solving abilities. This will make you stand out as a candidate who can drive continuous improvement.
✨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. Let’s get you on board!
We think you need these skills to ace Process Engineer
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!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about medical device manufacturing and how your background fits with our innovative team. Let us know what excites you about working with laser-based additive manufacturing technologies.
Showcase Relevant Experience: When detailing your experience, focus on specific projects or roles where you've led process validation activities or worked with ISO 13485 and FDA regulations. We love seeing concrete examples of how you've driven continuous improvement in past positions!
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s super easy, and we’ll be able to review your application quickly. Don’t miss out on the opportunity to join our dedicated team!
How to prepare for a job interview at Lynx Recruitment Limited
✨Know Your Regulations
Make sure you brush up on ISO 13485 and FDA CFR requirements before the interview. Being able to discuss how you've applied these standards in your previous roles will show that you're not just familiar with them, but that you can navigate the regulatory landscape effectively.
✨Showcase Your Process Validation Skills
Prepare specific examples of your experience with process validation (IQ/OQ/PQ). Be ready to explain how you've led validation activities in a regulated environment, as this is crucial for the role. Highlight any challenges you faced and how you overcame them.
✨Demonstrate Continuous Improvement Mindset
Think of instances where you've driven continuous improvement initiatives. Discuss how you optimised process efficiency and quality in your past roles. This will illustrate your proactive approach and commitment to excellence in manufacturing.
✨Collaborate and Communicate
Since the role involves working closely with Quality Assurance, Regulatory Affairs, and R&D teams, be prepared to talk about your collaboration experiences. Share how you’ve effectively communicated across departments to ensure seamless product development and compliance.
