We anticipate the application window for this opening will close on - 12 May 2025
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
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 Principal Manufacturing Engineer will join the NV GOSC team and focus on supporting sustaining optimization projects and qualifications.?Responsibilities of this position will include project management, validation procedures, manufacturing job instructions, execution of the validation, compilation of reports, coordinating of tasks and creating engineering change orders.?The role will interact directly with the manufacturing operators, supplier quality engineers, operations quality engineers, and design engineers to ensure proper qualification plan is followed.
Principal Manufacturing Engineer
Location: Onsite, Irvine, California ?
Responsibilities may include the following and other duties may be assigned.
Responsible for production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; minor redesign of devices and masks; analysis of customer returns; supplier related engineering changes and optimizing device production relative to cost constraints.
Assumes responsibility for device and/or internally produced or externally purchased components after transfer into high volume production and usually responsible for entire device manufacturing operations other than wafer fabrication.
May assist customer in device usage problems or customer testing of complex devices.
Key Accountabilities:?
Operations lead which includes manufacturing oversight and manufacturing dependent upstream and downstream processes.
Manufacturing primary point of contact for the engineering team supporting direct manufacturing
Quality Control oversight: Supporting the engineers to monitor and implement quality control measures at every stage of the manufacturing process, ensuring compliance with regulatory standards and internal quality requirements.
Process Improvement: Lead the engineers through continuously identifying and implementing process improvements to enhance product quality, reduce waste, and optimize manufacturing efficiency.
Risk Assessment: Conduct risk assessments related to manufacturing processes and identify potential areas for risk mitigation to ensure the safety and efficacy of medical devices.
Regulatory Compliance: Stay up-to-date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to these regulations.
MDR: Primary point of contact for the quality operations team for MDR, with potential for this position to assume the quality program manager on MDR.
Supplier Collaboration: Work closely with supplier engineering group to assess and improve the quality of incoming components and materials, fostering strong supplier relationships.
Root Cause Analysis: Lead the team through investigation and resolution of quality issues by performing root cause analysis and implementing corrective and preventive actions.
Documentation: Maintain accurate and complete documentation of quality-related processes, inspections, and testing, ensuring compliance with Good Manufacturing Practices (GMP).
Training: Provide training to manufacturing personnel on quality-related procedures, standards, and best practices.
Audit Support: Support internal and external audits, including FDA inspections, by providing documentation, data, and expertise related to manufacturing quality.
Product Testing: Oversee and coordinate product testing, validation, and verification processes to ensure products meet required specifications.
Mentor and provide technical guidance to junior engineers, fostering their professional growth and development within the organization.
Participate in the creation and execution of intellectual property strategies, including the drafting and filing of patent applications.
Must Have: Minimum Requirements??
Bachelor's degree required.
Minimum of 7 years of relevant medical device manufacturing engineering experience or related field, or advanced degree with 5 years of relevant medical device manufacturing engineering experience or related field.
Nice to Have:
Strong understanding and experience utilizing Lean/Sig sigma tools for continuous improvements
Experience with equipment development and process validation (IQ/OQ/PQ)?
Small tooling design and development??
Engineering experience with medical devices??
Electro-Mechanical troubleshooting skills??
Medical Device experience.
Small tooling design and development.
Design of Experiments (DOE).
Technical writing skills & updating documentation and procedures.
Knowledge of drafting standards, fixtures, and tooling a plus.
Strong statistical skills using Minitab.
Proficient in Microsoft Access, Excel, Project, Visio, and Word.
Knowledge of capital project budgets including forecasting and quoting a plus.
Experience developing statements of work, project charters, and project plans.
NCMR, CAPA, and Audit experience
Project management 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.
Salary ranges for U.S (excl. PR) locations (USD):$120,800.00 - $181,200.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple 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 match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital 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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page\name=signon&co\num=30601&co_affid=medtronic)
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 95,000+ 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 (http://www.medtronic.com) .
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 find here (https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) 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.
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 95,000+ 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.
We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will...
Build a better future, amplifying your impact on the causes that matter to you and the world
Grow a career reflective of your passion and abilities
Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
Better outcomes for our world . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
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.
For sales reps and other patient facing field employees, going into a healthcare setting?is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
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