Engineering Manager

Medtronic; Juncos (PR); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

MIP incentive

Job summary

Medtronic is seeking an Engineering Manager, Manufacturing to lead manufacturing engineering for robust production processes, validation, and continuous improvement in compliance with FDA, GMP, and ISO 13485 standards.

The role drives Lean Manufacturing, Six Sigma, CAPA, and cost optimization while managing cross-functional projects and engineering teams to achieve quality and productivity goals.

Qualifications

• Requires practical knowledge in leading and managing processes, projects and tactics within one job area.
• Typically has advanced knowledge in a technical discipline with impact on other areas.
• Requires a bachelor’s degree in engineering and minimum of 5 years relevant experience, or advanced degree with at least 3 years.

Responsibilities

• Plans, directs and implements design and development of new medical device products or software systems.
• Oversees investigation and evaluation of existing technologies.
• Guides conceptualization of new methodologies, materials, machines, processes or products.
• Directs development of concepts from design to market release.

Skills

Lean Manufacturing

Six Sigma

Quality Systems

Root cause analysis

Project management

Cross-functional leadership

Process optimization

Automation projects

Education

Bachelor’s degree in engineering

Job description

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 95,000 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.

A Day in the Life

The Engineering Manager, Manufacturing leads manufacturing engineering functions supporting the development, validation, implementation, and continuous improvement of production processes. This role is accountable for process robustness, equipment performance, automation projects, product transfers, process validations (IQ/OQ/PQ), and compliance with FDA, GMP, and ISO 13485 requirements. The Engineering Manager drives Lean Manufacturing and Six Sigma initiatives, supports CAPA and nonconformance investigations, and ensures manufacturing systems are optimized to achieve quality, productivity, and cost objectives while maintaining regulatory compliance and operational excellence.

Responsibilities may include the following and other duties may be assigned.

• Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
• May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
• Oversees the investigation and evaluation of existing technologies.
• Guides the conceptualization of new methodologies, materials, machines, processes or products.
• Directs the development of new concepts from initial design to market release.
• Manages feasibility studies of the design to determine if capable of functioning as intended.
• Monitors documentation maintenance throughout all phases of research and development.
• Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
• Selects, develops and evaluates personnel to ensure the efficient operation of the function.

Must Have: Minimum Requirements:

• Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
• Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.
• Requires a bachelor’s degree in engineering
• and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.
• Requires a bachelor’s degree in engineering
• and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.

Required Skills:

• Manufacturing Engineering leadership within a regulated manufacturing environment.
• Expertise in Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
• Experience with process validations (IQ/OQ/PQ), equipment qualification, and technology transfers.
• Strong knowledge of FDA regulations, GMP, ISO 13485, CAPA, and Quality Systems.
• Proficiency in root cause analysis, SPC, FMEA, DOE, and process optimization tools.
• Experience leading automation, productivity improvement, and cost reduction initiatives.
• Proven ability to manage engineering teams and cross-functional projects.
• Strong project management, communication, and stakeholder management skills.
• Ability to support manufacturing operations while driving quality, efficiency, and compliance objectives.

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.

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 impact. In 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.

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.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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.

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 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 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.