At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
Responsibilities may include the following and other duties may be assigned.
Plans directs and implements all quality aspects of the companys design and development of new implantable medical device products and systems with detailed focus on reliability risk management and patient safety.
Provide oversight and training in the application of work processes to ensure successful adoption by development teams and positive measurable results obtained from development programs.
Work closely with cross functional teams and quality peers to ensure project planning is complete end-to-end for both pre-market and post-market activities.
Manages activities to assure programs are appropriately resourced and ensure continuous improvement in technical capability process and compliance.
Provides oversight for the development and maintenance of quality programs systems processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Provides expertise and guidance in interpreting policies regulatory and/or governmental regulations and internal regulations to assure compliance.
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Ensures the quality assurance programs and policies are maintained and modified regularly.
Communicate program status using clear metrics and specific actions plans applying organizational acumen appropriate for a senior level audience.
Facilitates uniform standards worldwide and enables best practice sharing thereby fostering the achievement of companys mission globally.
Manages feasibility studies of the design to determine if capable of functioning as intended.
Selects develops and evaluates personnel to ensure the efficient operation of the function.
Must Have: Minimum Requirements- To be considered for this role please ensure the minimum requirements are evident in your applicant profile.
Bachelors degree required in Engineering Science or technical field with 7 years of experience in the medical device engineering space and 5 years of technical leadership or managerial experience OR Advanced Degree in Engineering Science or technical field with 5 years of experience in the medical device engineering space and 5 years of technical leadership or managerial experience.
Nice to Have
Direct experience in electrical/firmware design risk management reliability or systems engineering in a design engineering role.
Extensive experience in complex product development projects with strong knowledge of product development in regulated industries (such as medical device healthcare aerospace or transportation industries)
Working knowledge of 21 CFR 820.30 and ISO 14971
Working knowledge of ISO 13485 ISOCFR 820 and MDD/EU MDR.
Ability to author technical reports business correspondence and standard operating procedures.
Experience in applying metrics to measure and improve processes and product quality during product development.
Proven track record of success in leading cross functional efforts in work process improvement.
Experience in influencing educating and fostering others in adopting work practices.
Strong employment history of assuming successive organizational roles with increasing responsibility.
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).
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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
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 benefitshere.
In addition to Base Salary this position is eligible for a short-term incentive plan which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. Learn more about Medtronic Incentive Plan (MIP)here.
The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations).The rate offered is compliant with federal/local regulations and may vary by experiencecertification/education market conditions location etc.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.
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.
Medtronic offers a competitive Salary and flexible Benefits Package
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.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here.
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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Manager
About Medtronic 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 excit ... View more