Job Title
Principal Manufacturing Engineer
About the Role
The successful candidate will lead the technical delivery of manufacturing engineering activities within our organization. This includes ensuring project completion, meeting production goals, maintaining compliance with industry standards and regulations, and operating cost-effectively.
Responsibilities
1. Technical leadership in manufacturing transfer & ramp-up of new and existing products, using design for manufacturability principles.
2. Development and implementation of manufacturing capabilities using LEAN principles and tools such as Value Stream Mapping, Poka-Yoke, Standard Work, Bottleneck Analysis, and Line Balancing.
3. Experience working with Quality Assurance, managing NCMRs and CAPAs, monitoring suppliers, conducting audits, risk management, and ensuring compliance with ISO 13485 and other relevant standards for medical devices and pharmaceuticals.
4. Contribution to departmental and company goals.
6. Development and execution of manufacturing timelines aligned with project and regulatory requirements.
7. Financial modeling for COGS and scaling production capacity.
8. Technology transfer to manufacturing partners or contract organizations.
9. Promotion of continuous improvement culture and cost-saving initiatives.
10. Creation and management of the annual manufacturing project budget.
Requirements
* Bachelor's degree in engineering or related field with at least 10 years' experience, including 5 years in a technical leadership role within the medical device industry.
* Experience with ISO 13485/FDA regulated quality systems and risk management methodologies.
* Proven track record in manufacturing and process development in a regulated environment; experience with medical device catheters is a plus.
* Ability to achieve results within a co-located organization and work effectively with cross-functional teams.
* Passion for engineering principles and concepts, with a keen interest in how and why things work.
* Knowledge in DFM, technology evaluation, process design, materials, Six Sigma, CAD (preferably SolidWorks), statistical techniques, process validation, and manufacturing KPIs.
* Excellent analytical, decision-making, organizational, communication, and leadership skills.
* Ability to manage consultants, suppliers, vendors, and budgets efficiently.
* Capability to thrive in a fast-paced, high-growth environment, managing multiple tasks with high quality.
What We Offer
* Opportunity to work on cutting-edge imaging systems that benefit patients and improve healthcare.
* Part of a dynamic, multinational team with a strong focus on culture and individual development.
* A learning environment to expand your skills and interests.
* Flexible working arrangements, international culture, and offices in multiple locations.