At a Glance
- Tasks: Support product transitions, investigate feedback, and ensure quality standards in medical devices.
- Company: Join Endomag, a Hologic company, redefining cancer care with innovative solutions.
- Benefits: Competitive salary, personal growth opportunities, and a collaborative work culture.
- Other info: Dynamic role with travel opportunities and excellent career advancement potential.
- Why this job: Make a real impact in life-changing medical technology while working with a supportive team.
- Qualifications: Technical background in engineering and experience in high-tech or medical device industries.
The predicted salary is between 35000 - 45000 € per year.
Role location: Cambridge, UK
Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by shaping the future of cancer care. At Endomag, a Hologic company, we’re redefining cancer treatment and empowering clinicians worldwide with innovative medical solutions. We’re now looking for a Product Engineer to join our dynamic team in Cambridge —someone who thrives on solving complex challenges, driving excellence, and making an impact that truly matters.
As Product Engineer at Endomag, a Hologic company, you will play a critical role in supporting released products and managing the transition of new innovations from R&D to our manufacturing partners, collaborating closely with QA/RA and R&D teams. You will be responsible for investigating customer feedback, monitoring product performance and identifying opportunities for improvement in design, manufacturing and usage. Additionally, you will participate in post-market surveillance and work to address emergent failure modes, ensuring that products consistently meet the highest quality standards and deliver optimal outcomes for customers and patients. Due to the nature of the role, UK and international travel will be required - around 25%.
KEY RESPONSIBILITIES- Support the transfer of new products from R&D to manufacturing partners ensuring quality standards are met.
- Investigate emerging trending issues with products and work with manufacturers to resolve and address.
- Support change control processes and documentation in alignment with quality system requirements.
- Collaborate with cross-functional teams including Quality, Regulatory, Operations, and R&D.
- Work with the Repair Centre team to develop and improve repair processes for existing and new products.
- Participate in supplier audits, validations, and technical reviews.
- Work with supply chain to ensure product is supplied to stringent quality levels.
- Ensure compliance with all applicable medical device regulations, including ISO 13485, FDA 21 CFR Part 820, and MDR.
- Support regulatory submissions through compilation of Design History Files (particularly later stages), device manufacturing records and regulatory documentation.
- A technical or scientific background in engineering.
- Experience in high-tech engineering to exacting standards, ideally within the medical device industry.
- Understanding of quality and regulatory requirements, including ISO 13485, MDSAP, MDD/MDR, and 21 CFR.
- Excellent problem-solving skills and a detail-oriented approach. Problem solving methodology (8D, 5 Whys).
- Excellent written and verbal communication skills.
- Comfortable working in a high-compliance, fast-paced environment.
- Experience in Statistical Process Control (SPC) techniques for monitoring and improving manufacturing processes.
Ready to Make an Impact? If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!
Innovate with Purpose: Work at the forefront of life-changing medical technology.
Collaborative Culture: Join a friendly, supportive team where your contributions matter.
Personal Growth: Expand your skills in a fast-growing, global company.
Product Engineer in Bromham employer: Hologic
At Endomag, a Hologic company, we pride ourselves on being an exceptional employer that fosters a collaborative culture and prioritises personal growth. Located in the vibrant city of Cambridge, our team is dedicated to redefining cancer care through innovative medical solutions, offering employees the chance to make a meaningful impact while working alongside talented professionals. With opportunities for skill expansion and a commitment to quality and excellence, joining us as a Product Engineer means becoming part of a mission-driven organisation where your contributions truly matter.
StudySmarter Expert Advice🤫
We think this is how you could land Product Engineer in Bromham
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect with current employees at Endomag. A friendly chat can sometimes lead to opportunities that aren’t even advertised.
✨Tip Number 2
Prepare for interviews by researching Endomag’s products and recent innovations. Show us you’re passionate about making an impact in cancer care and have a solid understanding of the role's responsibilities.
✨Tip Number 3
Practice your problem-solving skills! Be ready to discuss how you’ve tackled complex challenges in the past. We love hearing about your thought process and how you approach issues.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows us you’re genuinely interested in joining our team at Endomag.
We think you need these skills to ace Product Engineer in Bromham
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the Product Engineer role. Highlight any relevant engineering background, especially in the medical device industry, and don’t forget to mention your problem-solving skills!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about cancer care and how your experience can contribute to our mission at Endomag. Keep it concise but impactful!
Showcase Your Technical Skills:Since this role requires a solid understanding of quality and regulatory requirements, make sure to mention any specific experience you have with ISO 13485 or FDA regulations. We want to see how you can help us maintain our high standards!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Hologic
✨Know Your Product Inside Out
Before the interview, make sure you thoroughly understand the products you'll be working with. Research Endomag's innovations and how they impact cancer care. This will not only show your enthusiasm but also help you answer questions about product performance and improvements.
✨Brush Up on Regulatory Knowledge
Familiarise yourself with key regulations like ISO 13485 and FDA 21 CFR Part 820. Be prepared to discuss how these standards apply to the role and how you can ensure compliance in your work. This will demonstrate your readiness to navigate the high-compliance environment.
✨Showcase Problem-Solving Skills
Prepare examples of how you've tackled complex challenges in previous roles. Use methodologies like 8D or 5 Whys to structure your answers. This will highlight your analytical skills and ability to drive excellence in product engineering.
✨Emphasise Team Collaboration
Since the role involves working closely with cross-functional teams, be ready to discuss your experience in collaborative environments. Share specific instances where you successfully worked with QA, R&D, or manufacturing partners to achieve a common goal.
