CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.
CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at .
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At CooperSurgical (CSI) we are currently looking to recruit a Sr. Design Quality Engineer to our team in Falmouth UK. You will be part of a team of experienced R&D engineers leading, designing and testing our medical device products developed on site and across the Global R&D team.
In this role you will be responsible for ensuring the safety, effectiveness, and compliance of our medical devices throughout the design and development lifecycle. The role reports directly to the Manager of Design Engineering.
Applicants must be eligible to work in UK and be on-site at Falmouth, Cornwall UK.
Position
In the role of Sr. Design Quality Engineer, you will be responsible for implementing and maintaining robust quality management systems, leading DQE deliverable to support design control activities, and collaborating with internal and external cross-functional teams to deliver cutting-edge medical solutions.
This individual will be expected to apply his/her knowledge of design control principles and quality engineering techniques to positively influence development efforts as needed. In parallel, this person shall also ensure the products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements. Review and evaluate scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems. This position also coaches, reviews and delegates work to lower level specialists.
You thrive in a dynamic and challenging environment. You will work closely with teammates and stakeholders in the wider organization. The position of Sr. Design Quality Engineer is vital for the success and growth of the CooperSurgical company.
Your key responsibilities
1. Drive and lead validation processes, testing and Verification
2. Identify and manage risk
3. Supplier engagement, evaluation and interaction
4. Create and support Continues improvement
5. CAPA/Non- conformance
6. Design Reviews and evaluations
7. Communicate key technical content to stakeholders
8. BSc / BEng in Electronics, Electrical Engineering, Robotics, Mechatronics or combination of related fields.
9. ≥ 4 years of experience from a similar role, - preferable medical device production
10. Expertise in analog and digital circuit design and layout using tools like Altium Schematic Capture.
11. Demonstrated skills in decision making preferably across a broad spectrum of Quality Engineering responsibilities
12. Proven experience leading cross-functional teams in a medical device development environment
13. Strong interpersonal, organizational and project management skills
14. Experience with Design for Manufacturing and Assembly (DFMA)
15. Fluent English (spoken and written) is mandatory