At a Glance
- Tasks: Lead manufacturing operations and drive new product introductions in a dynamic environment.
- Company: Innovative diagnostics and medical device manufacturer focused on impactful healthcare technologies.
- Benefits: Competitive salary, career growth, and a collaborative work culture.
- Other info: Join a purpose-driven team dedicated to improving healthcare outcomes.
- Why this job: Make a real difference in healthcare by overseeing cutting-edge medical device production.
- Qualifications: Experience in medical devices, diagnostics, or regulated manufacturing environments required.
The predicted salary is between 60000 - 80000 € per year.
Location: Wisconsin, USA
Industry: Manufacturing | NPI | Scale-Up | ISO13485
CY Partners are supporting an innovative diagnostics and medical device manufacturer in Wisconsin in the search for an experienced Operations Lead to oversee manufacturing operations and drive the successful transfer and scale‑up of new products into production. This is a hands‑on leadership role sitting at the intersection of Operations, Quality, and R&D, ideal for candidates with experience in IVD, lateral flow assays, diagnostics, or regulated medical device manufacturing environments.
Key Responsibilities
- Lead day‑to‑day manufacturing operations across safety, quality, delivery, and cost targets
- Drive technology transfer and new product introduction (NPI) from R&D into manufacturing
- Support process scale‑up, pilot builds, validation activities (IQ/OQ/PQ), and continuous improvement initiatives
- Ensure compliance with GMP, ISO13485, ISO9001, and FDA‑regulated quality systems
- Develop and mentor production teams while improving operational efficiency and reducing waste
- Collaborate cross‑functionally with Quality, Engineering, Supply Chain, and Technical teams
Ideal Background
- Experienced in medical devices, diagnostics, biotech, or lateral flow manufacturing
- Proven experience supporting technology transfer, process scale‑up, or NPI projects
- Strong understanding of regulated manufacturing environments and quality systems
- Leadership experience within production or operations teams
- Lean / Six Sigma experience advantageous
This is an excellent opportunity to join a growing and purpose‑driven organisation developing impactful healthcare technologies in a highly collaborative manufacturing environment.
Operations Lead -IVD / Medical Devices / Lateral Flow employer: Cypartners
Join a dynamic and purpose-driven organisation in Wisconsin that is at the forefront of developing innovative healthcare technologies. As an Operations Lead, you will thrive in a collaborative manufacturing environment that prioritises employee growth, offering mentorship and continuous improvement initiatives while ensuring compliance with industry standards. With a strong focus on operational efficiency and a commitment to making a meaningful impact in the medical device sector, this company stands out as an exceptional employer for those seeking rewarding careers in diagnostics and medical devices.
StudySmarter Expert Advice🤫
We think this is how you could land Operations Lead -IVD / Medical Devices / Lateral Flow
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those who work in IVD or medical devices. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO13485 and GMP regulations. We want you to show off your expertise in quality systems and how they relate to operations. Confidence is key!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Check out our website for roles that excite you, and tailor your approach to each one. We’re all about finding the right fit!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you top of mind. Mention something specific from your conversation to show you were engaged and are genuinely interested in the role.
We think you need these skills to ace Operations Lead -IVD / Medical Devices / Lateral Flow
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Operations Lead role. Highlight your experience in IVD, lateral flow assays, and any relevant manufacturing environments. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about the role and how your skills can drive our success in manufacturing operations. Keep it engaging and personal – we love a good story!
Showcase Your Leadership Skills:Since this is a hands-on leadership role, make sure to highlight your leadership experience. Share examples of how you've developed teams or improved operational efficiency in past roles. We’re looking for someone who can inspire and lead!
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 don’t miss out on any important updates. Plus, it shows you’re keen to join our team!
How to prepare for a job interview at Cypartners
✨Know Your Stuff
Make sure you brush up on your knowledge of IVD, lateral flow assays, and the specific manufacturing processes relevant to the role. Familiarise yourself with ISO13485 and FDA regulations, as these will likely come up during the interview.
✨Show Your Leadership Skills
Prepare examples that showcase your leadership experience in production or operations teams. Think about times when you successfully mentored team members or improved operational efficiency, as these stories will resonate well with the interviewers.
✨Be Ready for Technical Questions
Expect questions about technology transfer and new product introduction (NPI). Be prepared to discuss your experience with process scale-up and validation activities, as this is crucial for the role. Use specific examples to illustrate your expertise.
✨Collaborate and Communicate
Since the role involves cross-functional collaboration, be ready to talk about how you've worked with Quality, Engineering, and Supply Chain teams in the past. Highlight your communication skills and how they helped drive successful projects.
