Hardware Engineering Program Manager – Quality Core Team Member
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s Degree in Engineering, Science or Technical field with 5+ years of work experience in Engineering, Quality, Program Management and/or experience in a regulated industry OR Advanced Degree in Engineering, Science or Technical field with 3+ years of work experience in Engineering, Quality, Program Management and/or experience in a regulated industry
Nice to Have
- Biomedical, Electrical or Mechanical Engineering Degree preferred
- Hands-on electromechanical, electronic, or electrochemical sensor design experience
- Strong familiarity with reliability engineering and reliability assurance
- Direct experience in transferring products from development into manufacturing, and a deep understanding of process validation activities
- Experience in particular standards as they apply to various medical devices
- Experience in performing requirements analysis and verification testing activities
- Hands on experience in environments applying modern engineering practices (Lean, Agile).
- Experience in medical device industry.
- Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD/EU MDR.
- Demonstrated success in project management, with exceptional influence management skills
- Strong written and verbal communication skills
- Strong competencies in judgement and problem solving (especially root cause analysis)
- Proficient in spreadsheets and project management tools
- Working knowledge of multiple quality disciplines, especially reliability, safety and compliance
- Experienced practitioner of Design for Reliability and Manufacturability (DRM)
- Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices and to drug-device combinations.
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’s work together to address universal healthcare needs and improve patients’ 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)
Travel up to 25%
