Medical Device Product Lifecycle Expert
1 week ago
Job Title: Medical Device Product Lifecycle Expert
About the Role:
We are seeking a highly skilled and experienced Medical Device Product Lifecycle Expert to join our team at Michael Page. As a key member of our organization, you will play a vital role in managing product lines throughout their entire lifecycle.
About the Company:
Our client is a global innovator in the development and manufacturing of devices and services for the treatment of vascular disease. With a focus on collaboration and teamwork, they provide essential solutions that help surgeons deliver better outcomes for their patients.
Responsibilities:
- Collaborate with cross-functional teams to ensure all product requirements, both internal and external, are up-to-date and fully integrated into product development.
- Perform gap analyses on technical documentation and recommend improvements, initiating change orders for necessary updates.
- Identify, initiate, and manage design and process improvement projects aimed at enhancing device safety, quality, and performance.
- Support the CAPA process by ensuring product compliance with international standards, regulations, and internal requirements.
- Create protocols, generate reports, and conduct product testing to address gaps in Design V&V.
- Build strong relationships with multi-functional leaders to ensure alignment and effective execution of business objectives.
- Advocate for the voice of the customer in all decision-making, ensuring user needs are transformed into actionable design requirements that can be verified and validated.
- Ensure projects adhere to regulatory standards (GMP, GDP, ISO, EU MDR) and company policies and procedures.
- Capture and share insights gained during projects to enhance company processes and systems.
Requirements:
- Bachelor's degree in Engineering or a related technical field.
- At least 3 years of relevant experience with a proven record of success, including direct involvement in sustaining or developing products throughout their lifecycle.
- Strong problem-solving and execution skills, with the ability to devise creative solutions to complex challenges and achieve project goals.
- Familiarity with design controls and experience in developing devices by defining user needs, translating them into design inputs, and understanding the purpose of Verification and Validation testing.
- Ability to manage and prioritize schedule, cost, and quality considerations effectively.
- In-depth understanding of new product development processes or change management practices within the medical device or IVD industry.
- Proficiency in statistical techniques and their practical applications.
- Exceptional communication, teamwork, and influencing abilities.
- Proven ability to deliver project outcomes in dynamic and ambiguous environments.
What We Offer:
- A competitive salary of approximately $120,000 per annum.
- Extensive health and wellness benefits.
- Career development programs and mentorship.
- Creative, collaborative work environment.
- Flexible work arrangements for work-life balance.
- Access to cutting-edge technologies and continuous learning.
- Involvement in high-impact, innovative projects.
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