Medtronic is hiring a Senior Product Engineer for the EMEA headquarters of the organization, with a flexibility on the employee location within Europe. As a Product Engineer, you will play a crucial role in being responsible for designing transfer with respect to testing methods, procedures, device specification and compliance problems. Moreover, your contribution will be determinant to define strategy in product master validation project completion and set high quality standards to reach yields and process capabilities.
A Day in the Life
Be responsible for design transfer with respect to testing methods, procedures, device specification and compliance problems
Assume responsibility for device performance during and after transfer into high-volume production for entire device manufacturing operations
Analyze and mitigate product risks in collaboration with Process Development team (through pFMEA assessment)
Complete change control to NPI activities
Assess product compliance with respect to design specifications. Understanding product requirements and their associated design intent
Lead workshop event (kaizen) through multiple sites (Singapore, Switzerland, US)
Define strategy in product master validation project completion.
Providing constructive design feedback through fast prototyping and engineering builds
Set high quality standards to reach yields and process capabilities.
Collaborate in standardization across manufacturing sites
Support Project Manager\\xe2\\x80\\x99s activities and project stakeholders by acting as the technical expert and single point of contact for manufacturing process and technical related questions
Communicate with internal/external stakeholders at various organizational levels
Lead Technical Work Package execution
Responsibilities may include the following and other duties may be assigned.
Must Have
Experience in Medical Devices and/or Pharma industries (
4 years) * Exposure to Compliance/Quality Systems Regulations (e.g. GMP\\xe2\\x80\\x99s, process/document controls, CAPA, audits)
Engineering Degree (HES/EPF or equivalent)
Fluent in English
Nice to Have
Extensive expertise in manufacturing processes validation (IQ,OQ, PQ)
Knowledge and practice of Lean Manufacturing (e.g. continuous improvement mindset, process excellence)
Project management skills to lead/participate in local/global projects and initiatives
Extensive communication skills:
Strong leadership skills, proactive, flexible, results oriented and motivated by achievement
Strong analytical skills (e.g. applied to risk analysis, problem solving, to find creative/innovative solutions)
Proficient in Data analysis and Statistics (Cpk, Ppk, Confidence Interval, ANOVA, \\xe2\\x80\\xa6)
Autonomous, team player, contribute to others\\xe2\\x80\\x99 success beyond own expertise and organization
Decision making abilities, change agent, requires minimal supervision
Coaching skills to act as a global technology/product mentor
Excellent Microsoft Office practice and knowledge
DRM or Lean certifications (Green belt or Black belt)
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let\\xe2\\x80\\x99s work together to address universal healthcare needs and improve patients\\xe2\\x80\\x99 lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)