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Principal Reliability Engineer

2 months ago

Billerica, Massachusetts, United States Medtronic Full time

Careers that Change Lives

Engineers and Scientists create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide. Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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.

Join us to make a lasting impact. We believe that when people from different cultures, genders, and points of view come together, innovation is the result, and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. Help bring the next generation of life-changing medical technology to patients worldwide.

Medtronic's Cardiac Ablation Solutions division in searching for a dynamic Principal Reliability Engineer to join our growing team The chosen candidate will be heavily involved in supporting the design work for a critical ablation program. The Cardiac Ablation Solutions team is engaged in developing next generation of medical technologies that save lives and improves the quality of living for millions of patients across the world.

This role of Principal Reliability Engineer will be an on-site representative for Cardiac Ablation Solutions (CAS) Operating Unit (OU) post-market Reliability.

*The position will follow a hybrid schedule of 3 days onsite at 270 Concord Rd Billerica, MA 01821 with 2 days remote.

Primary Responsibilities

  • Managing and mitigating production and product impact throughout remediation efforts
  • Assessment and support of ongoing manufacturing changes and continuity activities (i.e. NCMR, Material outages, etc.) as risk management owner. Manufacturing includes capital systems (RF/PF generator, mapping system, pump) and complex single-use cardiac catheter manufacturing with rapidly expanding capacity/ramp-up at second facility (Billerica, MA)
  • Lead a small team (2-3) of contract engineers to complete remedial validation of in-process Test Methods

Required Qualifications

  • Bachelors degree
  • Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience

Preferred Qualifications

  • Foundational knowledge and expertise in risk management deliverables (i.e. DFMEA/PFMEA)
  • Experience in both capital equipment and single-use device design quality and/or design controls
  • Familiarity with manufacturing support/operations environment
  • Project Management skills and demonstrated team leadership with self-management and high accountability
  • Strong written and verbal communication skills and work cooperatively as part of a team and cross functionally
  • Ability to manage project timelines to execute deliverables in a timely manner
  • Ability to solve problems and innovate solutions
  • Quality experience working in a regulated industry
  • Experience working within complaint management system
  • Familiarity with these regulations: FDA 21 CFR Part 820 cGMP, ISO 13485, ISO 10012, and ISO 17025 within the Medical Device Industry

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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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