At a Glance
- Tasks: Join us as a Process Engineer to optimise medical device production and ensure quality compliance.
- Company: Be part of a leading medical technology company dedicated to innovative solutions for better patient outcomes.
- Benefits: Enjoy a full-time contract with opportunities for professional growth and collaboration in a dynamic environment.
- Why this job: Make a real impact in healthcare while working with cutting-edge technology and a passionate team.
- Qualifications: A degree in engineering or relevant experience in the medical device industry is essential.
- Other info: This role may require occasional travel outside the UK, but offers a vibrant workplace culture.
The predicted salary is between 36000 - 60000 £ per year.
Job Title: Process Engineer – 6 month contract
Job Type: Fixed Term Contract – Full Time
Location: Oxford, UK
A world-leading medical technology company developing cutting-edge solutions is seeking a skilled Process Engineer to drive the successful transfer and optimization of new medical device products and manufacturing processes from R&D into large-scale production as part of its global growth. This role offers the opportunity to work in a dynamic, innovative medical device organization dedicated to improving patient outcomes.
As a Process Engineer, you will play a key role in ensuring that new products are introduced to market efficiently, with a strong focus on compliance, quality, safety, and scalability. You will be responsible for developing, validating, and continuously improving manufacturing processes, while collaborating closely with cross-functional teams including R&D, Quality, Regulatory, and Manufacturing to enable smooth scale-up and commercialization.
Responsibilities:
- Working closely with the other departmental Process Engineer (CI) and the Process Engineer (NPI).
- Creating and reviewing Specifications, Standard Operating Procedures and Work Instructions.
- Working closely with the Regulatory Affairs and Quality departments to ensure compliance with relevant medical device regulations.
- Creating and reviewing Change Controls (CCs), Risk Assessments (RAs), Root Cause Analysis investigations, Supplier Corrective Action Reports (SCARs), Nonconformance Reports (NCs), Corrective and Preventive Actions (CAPAs) and other internal & external documentation needed to support the CI programs.
- Drafting and executing validation and qualification protocols for production and test equipment, along with relevant processes used in manufacturing (internal & external) and servicing.
- Assisting with specifying, sourcing and commissioning of tooling/equipment required for CI activities.
- Working collaboratively with colleagues on all levels in all departments to improve current processes and develop a culture of continuous improvement.
- Actively contributing towards the sites Health, Safety, Environmental and Sustainability requirements and targets.
- Assisting with general duties associated with a busy, expanding site.
Requirements:
- A degree/equivalent qualification (in process, manufacturing, mechanical, biomedical or general engineering, or other relevant discipline) or experience in the medical device industry (or a comparably highly regulated industry) (essential).
- Good working knowledge or qualifications in improvement methodologies such as Lean or Six Sigma (Green Belt desirable)
- Good working knowledge or qualifications in process Design & Review (DFx)
- Good working knowledge of the Safety, Quality and Regulatory Standards applicable (ISO 14971, IEC 60601, ISO 13485 etc) to manufacture of medical devices (desirable)
- Good practical skills and experience in the manufacture, release testing and servicing of safety-critical devices (desirable)
- A hands-on approach to developing, evaluating, and improving processes
- The ability to evaluate, explain and simplify complex technical issues.
- Proven strong knowledge and understanding of formal engineering/process principles and techniques.
- Previous experience writing clear and concise Work Instructions, Standard Operation Procedures and other relevant Quality Documentation; acting as a Quality Technical writer.
- The ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English.
- Good understanding of manufacturing equipment and related systems.
- Experience with validation protocols (IQ/OQ/PQ), FMEA, and control plans.
- Familiarity with digital manufacturing, Industry 4.0, or MES systems.
- Strong and concise communication skills, both verbal and written.
- The ability to work effectively with outside suppliers and manufacturers.
- Self-motivated and driven to succeed.
- Very strong collaborative skills.
- The ability to work across a wide range of projects simultaneously.
- Willing and able to travel outside UK on occasion (less than 20% of time).
Process Engineer employer: Skills Alliance
Contact Detail:
Skills Alliance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Process Engineer
✨Tip Number 1
Network with professionals in the medical device industry. Attend relevant conferences, workshops, or webinars to meet potential colleagues and learn about the latest trends. This can help you gain insights into the company culture and possibly get a referral.
✨Tip Number 2
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as ISO 13485 and IEC 60601. Being able to discuss these in detail during an interview will demonstrate your commitment and knowledge of the field.
✨Tip Number 3
Prepare to showcase your experience with Lean and Six Sigma methodologies. Think of specific examples where you've successfully implemented process improvements, as this will highlight your practical skills and hands-on approach.
✨Tip Number 4
Research the company’s recent projects and innovations in medical technology. Being knowledgeable about their products and initiatives will allow you to tailor your conversation and show genuine interest during interviews.
We think you need these skills to ace Process Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience and skills that align with the Process Engineer role. Emphasise your background in process, manufacturing, or biomedical engineering, and any experience you have in the medical device industry.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for medical technology and your understanding of the role. Mention specific experiences where you've successfully implemented process improvements or worked collaboratively with cross-functional teams.
Highlight Relevant Qualifications: Clearly list any qualifications related to Lean, Six Sigma, or other improvement methodologies. If you have experience with ISO standards or validation protocols, make sure to include that as well.
Showcase Communication Skills: Since strong communication skills are essential for this role, provide examples in your application of how you've effectively communicated complex technical issues in previous positions, whether through reports, presentations, or documentation.
How to prepare for a job interview at Skills Alliance
✨Showcase Your Technical Knowledge
As a Process Engineer, it's crucial to demonstrate your understanding of engineering principles and methodologies. Be prepared to discuss specific examples from your past experience that highlight your knowledge of Lean, Six Sigma, and relevant regulatory standards like ISO 13485.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world situations. Think of scenarios where you had to conduct Root Cause Analysis or implement Corrective and Preventive Actions. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Emphasise Collaboration Skills
This role requires working closely with various departments. Highlight your experience in cross-functional teams and how you've successfully collaborated with R&D, Quality, and Regulatory Affairs to achieve project goals. Share specific instances where teamwork led to improved processes.
✨Demonstrate Continuous Improvement Mindset
The company values a culture of continuous improvement. Be ready to discuss how you've contributed to process optimisation in previous roles. Mention any initiatives you've led or participated in that resulted in enhanced efficiency or quality in manufacturing processes.