Job Information
Medtronic Senior Mechanical Reliability and Safety Engineer in Mounds View, Minnesota
Senior Mechanical Reliability and Safety Engineer
Careers That Change Lives
At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday, and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
The Cardiac Rhythm Management (CRM) Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure.
We are comprised of three businesses:
· Cardiac Pacing Therapies
· Cardiovascular Diagnostics & Services
· Defibrillation Solutions
We put people first in all we do. We remain on the leading edge of innovation to ensure that we treat more people. We excel in how we operate to deliver the best experiences for people who touch our therapies.
In this exciting role as a Senior Mechanical Reliability and safety Engineer, you will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.
This position is remote position within the Cardiac Rhythm Management (CRM) Operating Unit.
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.
A Day in the Life
In general, the following responsibilities apply for the Senior Mechanical Reliability and Safety Engineer role. This includes, but is not limited to the following:
· Collaborates with cross-functional teams to develop and release new cardiac rhythm management products and design changes.
· Plans, leads, and integrates Design for Reliability (DfR) activities on product development projects to drive product safety, complaint reduction, reliability, and quality outcomes that exceed patient, customer, company, and regulatory agency expectations.
· Evaluates designs for potential failure modes, assesses potential hazards and harms, prioritizes safety risks, identifies appropriate risk controls, and compiles evidence to demonstrate benefits outweigh product risks.
· Defines and allocates reliability requirements and goals, develops and leads reliability demonstration strategies, manages completion of reliability growth activities, and recommends design and manufacturing updates to ensure design achieves required levels of product reliability.
· Understands legacy product performance and incorporates learnings into new product development projects.
· Develops test plans, determines statistically valid sample sizes, works with test labs to demonstrate performance, addresses test observations, statistically analyzes data, and writes test reports.
· Articulates risk management and reliability activities and conclusions in documentation, regulatory submissions, and audits.
· Performs engineering reviews of quality records for safety and reliability impact.
· Advocates for safety, reliability, and quality in design reviews and other project meetings.
Specialized Knowledge Required:
· One or more of following qualifications:
o Medical Doctor with related device experience
o Engineer who has achieved IBHRE Exam certification
o Personnel with at least 5 years of previous clinical experience related to cardiac implantable products
o Personnel with at least 5 years of clinical field experience in the past 15 years. The relevant field experience could include the following:
§ Nurse
§ Field Personnel such as: Clinical Specialist, Technical Field Educator, Field Clinical Engineer
§ Technical Services (cardiac products)T
Must Have - Minimum Requirements
TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME
· Bachelor’s degree required in engineering, math, science, or a technical discipline
· Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Nice to Have
· Implantable medical device industry experience
· Advanced degree in Engineering or suitable Clinical/Field Support, Safety or Reliability Engineering, Biomedical Engineering, Mechanical Design Engineering, or Product Development Engineering experience
· Knowledge of cardiac anatomy, physiology, and primary disease states
· Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, ISO 14971, and Hazard Analysis and Risk Analysis techniques (e.g., FTA, DFMEA, Hazard Analysis Logs, Risk Management Report & Files)
· Certification (belts) in Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices
· ASQ CRE certified
· Strong written and verbal communication skills and ability to work cooperatively and influence outcomes as part of a cross-functional team
· Ability to manage project timelines to execute tasks and deliverables in a timely manner
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)
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic) .
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .
The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
Base pay is based on numerous factors and may vary depending on job-related knowledge, skills, and experience.
Min Salary
104800
Max Salary
157200
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.