Post-Market Quality Engineering Manager, Santa Ana, CA or Santa Rosa, CA
Post-Market Quality Engineering Manager, Santa Ana, CA or Santa Rosa, CA
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$ 157600 - 236400
1 Vacancy
Job Description
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.
A Day in the Life
A career at Medtronic is like no other. Were purposeful. Were committed. And were driven by our Mission to alleviate pain restore health and extend life for millions of people worldwide.In this exciting role as a Post Market Quality Senior Engineering Manager you will lead the Aortic Post Market Product Assurance and Quality Sustaining team based in Santa Rosa CA for all commercial Aortic products for our Structural Heart and Aortic business.
At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working onsite 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.
In general the following responsibilities apply but is not limited to the following:
- Manages a team of Reliability Engineers that are responsible for monitoring product performance complaint investigations and evaluating quality issues impacting released product
- Manage a team responsible for all Design Assurance activities supporting changes to commercial products.
- Coach team members through technical problem solving including CAPA investigations and triaging issues.
- Provide technical knowledge and input into risk assessments when quality issues are being evaluated.
- Provide front room support during inspections from regulatory agencies (e.g. FDA FDB Notified Body).
- Manage performance and develop talent to support a high performing team and culture.
- Demonstrate the ability to communicate influence and negotiate with internal cross-functional employees internal leaders at all levels and external customers in the pursuit of product quality improvements and post-market risk management.
- Create strategic plans for driving efficiencies improving competencies and developing people to continuously improve function.
- Provide oversight and expertise in design change control and risk management activities.
Must Have: Minimum Requirements: To be considered for this role please ensure the minimum requirements are evident on your resume.
- Bachelors degree
- Minimum 5 years of relevant experience OR advanced degree with a minimum of 3 years of relevant experience.
Nice to Have:
- Bio-medical engineering degree
- Prior experience in or demonstrated strong working knowledge of global medical device regulations and requirements.
- Experience dealing directly with U.S. FDA and/or other medical product competent authorities/regulatory authorities.
- Engineering experience with medical devices specifically disposable devices.
- Thorough working knowledge of medical device industry product risk management regulations and standards
- Understanding of heart anatomy and human/blood physiology
- Demonstrated Aortic product application knowledge
- Strong communication skills (written verbal listening (with all levels of the organization). Strong interpersonal and problem-solving skills.
- Experience supporting cross-functional and cross-regional teams in a matrixed org. developing collaborative relationships.
- Identifies and resolves issues in a proactive creative and timely fashion.
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.
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 benefitshere.
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 experiencecertification/education market conditions location pay is based on numerous factors and may vary depending on job-relatedknowledge skills and experience.
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.
Benefits & Compensation
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
About Medtronic
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 law. In 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
Employment Type
Full-Time
