Principal Manufacturing Engineer

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.

This person will be responsible for driving operational excellence by ensuring the successful design development deployment operation and optimization of the Manufacturing Execution System (MES). Conduct various studies pertaining to cost reduction Return on Investment (ROI) inventory control and production record systems. Define Manufacturing Execution System (MES) architecture configuration and implementation of MES workflows to support production operations and regulatory traceability. Define Standard Operating Procedure (SOP) and data models linking MES with ERP (Enterprise Resource Planning) and other Manufacturing and quality systems within the manufacturing environment. Comply with Medical industry standards system testing and validation according to Good Manufacturing Practices (GMP) 21 CFR Part 11 requirements regulations and quality mgmt. requirements by conducting audits and implementing controls to ensure regulatory compliance. Monitor performance of the MES system to ensure efficiency by analyzing system metrics identifying areas for optimization and implementing system enhancements. Apply DMAIC (Design Measure Analyze Improve and Control) problem solving methodologies. Develop and maintain digital manufacturing documentation including work instructions and process maps within the MES framework. Conduct Installation Qualification Operational Qualification and Performance Qualification (IQ/OQ/PQ) system validation protocols involving test steps per production line to ensure MES compliance with regulations.

• Lead the implementation enhancement and ongoing support of Manufacturing Execution Systems (MES) to improve manufacturing performance quality compliance and operational efficiency.

• Partner with Operations Manufacturing Quality Engineering and IT teams to design optimize and deploy digital manufacturing solutions.

• Develop and maintain manufacturing workflows system configurations work instructions and technical documentation to support business processes.

• Drive continuous improvement initiatives through analysis of manufacturing processes system performance and operational data.

• Ensure manufacturing systems comply with applicable regulatory requirements and internal quality standards.

• Support system validation activities including protocol development testing documentation and change control processes.

• Manage complex cross-functional projects related to manufacturing systems automation and process improvements.

• Provide technical leadership and subject matter expertise for MES architecture system integration and manufacturing technologies.

• Train and mentor users on manufacturing systems processes and best practices.

• Collaborate with stakeholders to identify business needs and translate requirements into scalable manufacturing solutions.

Required Qualifications:

• Bachelors degree in Engineering Manufacturing Engineering Industrial Engineering Computer Science Information Systems or related technical field.

• 7 years of experience in manufacturing engineering manufacturing systems digital manufacturing MES or related technical disciplines.

• Experience implementing supporting or optimizing Manufacturing Execution Systems (MES) in a regulated manufacturing environment.

• Experience working with ERP quality and manufacturing systems integrations.

• Knowledge of manufacturing process controls quality systems and regulatory requirements including GMP and 21 CFR Part 11.

• Experience supporting software validation and qualification activities within regulated industries.

• Advanced degree in Engineering Manufacturing Operations or related field.

• Medical device pharmaceutical biotech or other highly regulated industry experience.

• Experience with MES platforms such as Tulip Camstar Opcenter FactoryTalk PAS-X or similar solutions.

• Experience with electronic batch records (EBR) or electronic device history records (eDHR).

• Lean Manufacturing Six Sigma Green Belt/Black Belt or equivalent continuous improvement certification.

• Experience supporting digital transformation Industry 4.0 smart factory or connected manufacturing initiatives.

• Experience developing manufacturing dashboards KPIs and data analytics solutions.

• Project Management certification (PMP) or equivalent project leadership experience.

• Experience supporting internal customer or regulatory audits.

For Baccalaureate degrees earned outside of the United States a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.

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.

U.S. Work Authorization & Sponsorship

At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful alignment with our enterprise-wide workforce planning approach U.S. work authorization sponsorship (H-1B TN J etc.) is offered exclusively for Principal-level roles and above where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.

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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

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.